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The module Anamnesis and Clinical Diagnosis (incl. Basic Data Set) is used to accurately record known cardiovascular risk factors, previous diagnoses and interventions. The collected findings enable a detailed assessment of a patient’s cardiovascular risk. The module contains among others the mandatory basic data set with 42 items. In the following, these items are labeled with **.
The examinations ought to be performed according to DZHK-SOP-K-02 .
 
As of

General information relating to the anamnesis

Date of examination**

is defined as the date on which the examination takes place. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_datum
  Data type: Timestamp with day, month and year
  Figure: Number of records cumulatively by date of invastigation

Quality level

  • Level 1: The examination is performed in accordance with the guidelines of the medical associations.
  • Level 2: The examination is performed in accordance with the specifications of the DZHK SOP. Minimum requirements to ensure the quality of the implementation and the examiners are defined in the SOP.
  • Level 3: The examination is performed in accordance with the specifications of the DZHK SOP and certification of the examiners: Definition of intr-observer and interobserver-variability (standard of epidemiological studies).
DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: gehtest_qualitaet
  Data type: Integer with following options
    1
    2
    3

Physical Examination and Sociodemographic Data

Sex and date of birth**

are defined as the data which appear on the person’s identity card. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_geschlecht
  Note in CRF: Sex
  Data type: String with following options
    male
    female
    unknown
    not assessed
  Figure: Number of records by sex
  Fieldname: basis_gebdatum
  Note in CRF: Date of Birth
  Data type: Timestamp with month and year
  Figure: Number of records by year of birth

Height and weight**

Height is measured in the standing position, without shoes and without head covering. Weight is measured in normal street clothing, without a jacket and without shoes. Preferentially, measured data should be collected; only when this is not possible (e.g. in the case of bed-ridden patients) should one estimate the values or resort to information provided by the proband. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_groesse
  Note in CRF: Height
  Data type: Integer with 3 decimal places
  Figure: Number of records by height in centimetre
  Fieldname: basis_gewicht
  Note in CRF: Weight
  Data type: Integer with 3 decimal places
  Figure: Number of records by weight in kilogram

Ethnicity and skin colour**

A person’s ethnic origin is defined by their ancestry in relation to a specific ethnic group. This can be determined biologically and/or geographically on the basis of membership of a certain settlement group. Accordingly, a person’s skin colour can also be broadly defined. The colour spectrum can be differentiated from light to dark skin colour. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_ethnie
  Note in CRF: Ethnicity: kaukasian
  Data type: String with following options
    yes
    no
    unkown
    not assessed
 Figure: Number of records by ethnicity
  Fieldname: basis_hautfarbe
  Note in CRF: Black skin colour
  Data type: String with following options
    yes
    no
    unkown
    not assessed
 Figure: Number of records by skin colour

Family history of myocardial infarction or stroke**

is defined as a medically diagnosed myocardial infarction or stroke in one or both biological parents, biological siblings (including half-siblings) or biological children, provided the female relative was under age 65, or the male relative under age 55 (when the myocardial infarction/stroke occurred). DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_family
  Note in CRF: Family history of myocardial infarction or stroke in parents, siblings or children under the age of 65 for women or under 55 for men
  Data type: String with following options
    yes
    no
    unknown
    not assessed
  Figure: Number of records by family history of myocardial infarction or stroke

Cardiovascular risk factors

Diabetes mellitus**

is defined as diabetes which has been diagnosed and/or treated by a doctor. The American Diabetes Association criteria are:
  • haemoglobin A1c ≥ 6.5 % or a fasting blood glucose level of ≥ 126 mg/dl or a
  • 2-hour blood glucose level of ≥ 200 mg/dl in the oral glucose tolerance test.
DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_diabetes
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by Diabetes mellitus

Arterial hypertension**

is defined as a current or previous diagnosis of arterial hypertension which was diagnosed and/or is being treated by a doctor. Treatment can consist of e.g. dietary changes, physical activity and/or medication. Systolic blood pressure values ≥ 140 mmHg and/or diastolic blood pressure values ≥ 90mmHg measured by a doctor on at least two separate days after a 5-minute resting phase qualify for a diagnosis of arterial hypertension. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_hypertonie
  Data type: String with following options
    yes
    no
    unkown
    not assessed
 Figure: Number of records by arterial hypertension

Dyslipidaemia**

is defined as a current or previous diagnosis of dyslipidaemia which was diagnosed and/or is being treated by a doctor. One or more of the following criteria:
  • total cholesterol ≥ 200 mg/dl,
  • LDL cholesterol ≥ 130 mg/dl,
  • HDL cholesterol < 40 mg/dl (men) and < 50 mg/dl (women).
DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_dyslipi
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by dyslipidaemia

Smoker

Smoker**

is defined as current or previous use of cigarettes, cigars, pipes or smokeless tobacco.
  • “Yes” for daily or occasional smoking (≥ 1x/month);
  • “Ex-smoker“ for abstinence of more than 6 months; ex-smoker since …;
  • “No“ for “never smoked“.
DZHK-SOP-K01: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_raucher
  Note in CRF: Smoker
  Data type: String with following options
    yes
    no
    ex-smoker (stopped ≥ 6 mth. ago)
    unkown
    not assessed
 Figure: Number of records by smoker

Ex-Smoker**

  Fieldname: basis_exrauch
  Note in CRF: Ex-smoker since
  Data type: Timestamp with year

Pack years

is the product of the number of years of cigarette smoking multiplied by the average number of packs smoked per day.
Example: A patient who has smoked 2 packets of cigarettes per day for 20 years has 40 pack years.
DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_packyear
  Data type: Integer with 3 decimal places

Drinks per week

is the number of alcoholic drinks consumed per week. One drink is defined as e.g. 0.25 l of beer, 0.1 l of wine or 0.02 l of spirits.
Example: A patient who drinks 0.5 l beer on average two times every week has 4 drinks per week.
DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_drinksweek
  Date type: Integer with 3 decimal places

Medically diagnosed alcoholism

is defined as a current or previous diagnosis of alcoholism which was diagnosed and/or is being treated by a doctor. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_alkoholkrank
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Renal failure

Renal failure

This includes all patients who exhibit reduced renal function. If known, the degree of renal dysfunction should be quantified by the estimated Glomerular Filtration Rate (eGFR). Different estimation methods exist; if available, the formula that follows the MDRD formula should be used. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
 
  Fieldname:basis_niereinsuf
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Degree of renal dysfunction

 
  Fieldname:basis_niereinsufgrad
   Data type: String with following options
    1 - GFR 90ml/min or higher
    2 - GFR 60-89ml/min
    3 - GFR 30-59ml/min
    4 - GFR 15-29ml/min
    5 GFR < 15ml/min or current dialysis dependency
    unkown
    not assessed

Current dialysis dependency**

is defined as current regular, at least weekly, renal replacement therapy (including haemodialysis and peritoneal dialysis) within the last 30 days. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_dialyse
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by current dialysis dependency

Cardiac Diagnoses (Anamnesis and Previous Findings)

Coronary heart disease**

is defined as a current or previous diagnosis by a doctor with one or more of the following criteria:
  • coronary artery stenosis of ≥ 50 % (diagnosed by cardiac catheterization or another direct coronary artery imaging method),
  • prior coronary artery bypass operation,
  • prior percutaneous coronary intervention,
  • arteriosclerosis-induced myocardial infarction.
DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_khk
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by coronary heart disease

Status post myocardial infarction**

is a diagnosis of the disease by a doctor. Explanation: Acute myocardial infarction is defined as demonstrated evidence of myocardial necrosis in a clinical setting which is consistent with myocardial infarction. One or more of the following criteria must apply: Evidence of an increase or decrease of a cardiac biomarker (preferably troponin) with at least one value above the 99 % percentile of the upper reference limit and, additionally, at least one of the following factors:
  • symptoms of ischaemia, angina pectoris,
  • ECG changes indicative of new ischaemia, e.g. ST segment elevations or a new left bundle branch block, development of pathological Q waves in the ECG,
  • imaging studies show a loss of viable myocardial tissue or new regional wall motion abnormalities
  • angiographic evidence of stenosis/blood vessel blockage.
DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_myokard
  Data type:  String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by status post myocardial infarction

Cardiomyopathy**

is defined as a diagnosis by a doctor of a primary heart muscle disease. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
If the following question is answered with “yes”, please complete the Cardiomyopathy Diagnostics form.
  Fieldname: basis_kardmyopath
  Note in CRF:If the response to this question is “yes”, please complete the “Cardiomyopathy Diagnostics” form.
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by cardiomyopathy

Heart failure

Heart failure**

is defined as a current or previous diagnosis and documentation by a doctor of heart failure, based on the following symptoms: shortness of breath with mild exertion, recurrent shortness of breath when sitting, fluid overload or pulmonary rales, distention of the neck veins, pulmonary oedema on physical examination or pulmonary oedema on chest x-rays. Documentation of reduced left ventricular function alone in the absence of clinical signs of heart failure does not meet the criteria for heart failure. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_insuffizienz
  Data type: String with following options
    yes
    no
    unkown
    not assessed
 Figure: Number of records by heart failure

S.p. decompensation

Status post decompensation is defined as any previous admission to a hospital with symptoms of heart failure (see above). DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_herzin_dekom
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Initial diagnosis of heart failure

Initial diagnosis of heart failure is defined as the time point when heart failure was diagnosed for the first time by a doctor. Hence it does not refer to the time point of first onset of symptoms, which is often much earlier. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_herzin_jahr
  Data type: Timestamp with year

Current NYHA class

Classification of the patient’s symptoms based on the New York Heart Association classification of heart failure:
  • NYHA I: No symptoms
  • NYHA II: Symptoms with heavy physical exertion
  • NYHA III: Symptoms with light physical exertion
  • NYHA IV: Symptoms while at rest
DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_herzin_nyha
  Data type: String with following options
    I
    II
    III
    IV
    unkown
    not assessed

Atrial fibrillation/flutter**

is defined as a current or previous diagnosis by a doctor of atrial fibrillation or atrial flutter. It is defined as an episode of atrial fibrillation or atrial flutter lasting at least 30 seconds or atrial fibrillation with evidence on the surface ECG or during pacemaker interrogation. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_vorhof
  Data type: String with following options
    yes
    no
    unkown
    not assessed
Figure: Number of records by atrial fibrillation/flutter

Current or previous medical diagnosis of heart valve disease**

is defined as heart valve disease (incompetence or stenosis), which has been diagnosed and/or treated by a doctor. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_herzklap
  Data type: String with following options
    yes
    no
    unkown
    not assessed
 Figure: Number of records by heart valve disease

Diagnosis by a doctor of endocarditis

If at any time, currently or in their previous medical history, a patient has been diagnosed by a doctor with endocarditis (heart valve inflammation), it will be documented here. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_endo
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Diagnosis by a doctor of a congenital heart defect**

If a patient has a known congenital heart defect, it will be coded here. Congenital heart defects include shunt defects (e.g. ASD, VSD), congenital valvular heart diseases (e.g. pulmonary stenosis) and cardiomyopathies diagnosed in the first five years of life. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_ahf
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by congenital heart defect

Previous cardiovascular interventions

Interventional coronary revascularization

Interventional coronary revascularization**

is defined as a percutaneously performed intervention on a coronary artery, e.g. PTCA, stent implantation, rotablation et cetera. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_revas
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by revascularization

If yes, date of last intervention

Where applicable, the date of the last intervention should be entered. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_revas_date
  Data type: Timestamp with month and year

Peripheral revascularization

Peripheral revascularization

is defined as a percutaneously performed intervention on a peripheral artery (not including coronary arteries or bypass grafts) e.g. PTA, stent implantation, rotablation et cetera. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_perirevas
  Data type: String with following options
    yes
    no
    unkown
    not assessed

If yes, date of last intervention

Where applicable, the date of the most recent intervention should be entered.
DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_perirevasdate
  Data type: Timestamp with month and year

Coronary bypass operation

Coronary bypass operation**

is defined as operative myocardial revascularization by means of a bypass graft (e.g. from the internal thoracic artery or using arterial/venous grafts). Where applicable, the date of the most recent operation should be entered. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_bypass
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by coronary bypass operation

If yes, date of last intervention

Where applicable, the date of the most recent operation should be entered. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_bypass_date
  Data type: Timestamp with month and year

Other vascular operation

Other vascular operation

is defined as an operation of any kind on non-coronary blood vessels. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_gefaessop
  Data type: String with following options
    yes
    no
    unkown
    not assessed

If yes, date of last intervention

Where applicable, the date of the most recent operation should be entered. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_gefaessopdate
  Data type: Timestamp with month and year

Heart valve operation

Heart valve operation**

is defined as a minimally invasive percutaneous (catheter-based) or open surgical procedure on a heart valve. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_herzklap_op
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by heart valve operation

If yes, date of last intervention

Where applicable, the date of the most recent operation should be entered. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_herzklopdate
  Data type: Timestamp with month and year

Type of last intervention

The most recent event is to be coded according to type, whereby any transapical aortic valve replacements are to be coded as “catheter-based“. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_herzklopart
  Data type: String with following options
    open surgery
    catheterbased
    unkown
    not assessed

If open surgery

In addition, details of the surgical procedure should be given. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_herzklopchir
  Data type: String with following options
    replacement
    reconstruction
    unkown
    not assessed

If more than one procedure on one valve was performed, please provide details of the last Op (= current state)

Aortic valve
  Fieldname: basis_aort
  Data type: String with following options
    native
    reconstruction
    mechanical prosthesis
    bioprosthesis (open)
    TAVI
    unkown
    not assessed
  Fieldname: basis_taviauspraeg
  Data type: String with following options
    transfemoral
    transapical
    transaortal
    unkown
    not assessed
Pulmonic valve
  Fieldname: basis_pulm
  Data type: String with following options
    native
    reconstruction
    mechanical prosthesis
    bioprosthesis (open)
    unkown
    not assessed
Mitral valve
  Fieldname: basis_mitral
  Data type: String with following options
    native
    reconstruction
    mechanical prosthesis
    bioprosthesis (open)
    clipping
    unkown
    not assessed
Triscuspid valve
  Fieldname: basis_trik
  Data type: String with following options
    native
    reconstruction
    mechanical prosthesis
    bioprosthesis (open)
    unkown
    not assessed

Implantable cardiac pacemaker or defibrillator

Implantable cardiac pacemaker or defibrillator**

is defined as status post implantation of a cardiac pacemaker or intracardiac defibrillator. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_schrittmacher
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by pacemaker/defibrillator

If yes, what was implanted?

  Fieldname: basis_schrittart
  Data type: String with following options
    pacemaker
    defibrillator
    unkown
    not assessed

If yes, date of last event (implantation/exchange)

Where applicable, the date of the most recent operation (implantation/exchange) is to be entered. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_schrittdate
  Data type: Timestamp with month and year

If pacemaker, please give pacemaker type

In addition, the number of leads currently connected to the pacemaker power supply should be coded. A device with only one lead should be coded as a 1-chamber pacemaker, a device with an atrial and a ventricular lead should be coded as a 2-chamber pacemaker. Devices for cardiac resynchronization therapy, with 2 ventricular leads, should be coded as biventricular (CRT) pacemakers. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_schritttyp
  Data type: String with following options
    1-chamber-pacemaker (e.g. VVI)
    2-chamber-pacemaker (e.g. DDD)
    biventricular pacemaker (CRT)
    unkown
    not assessed

Other devices

are defined as other implantable devices for cardiac/vascular support. This includes devices for cardiac contractility modulation, for neuromodulation (e.g. vagus nerve stimulator, baroreceptor stimulator), intra-aortic balloon pumps and left ventricular cardiac assist devices. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014

Other devices

  Fieldname: basis_schrittandere
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Cardiac contractility modulation (CCM)

  Fieldname: basis_schrittccm
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Intra-aortic balloon pump (IABP)

  Fieldname: basis_schrittiabp
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Other devices

  Fieldname: basis_schrittsonst
  Data type: Free text

S.p. myocardial biopsy

S.p. myocardial biopsy

is defined as status post bioptic removal of tissue from the heart muscle (e.g. during a right/left catheter examination or operation). DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_biopsie
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Date of myocardial biopsy

Where applicable, the date of the most recent myocardial biopsy should be coded. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_biopsie_date
  Data type: Timestamp with month and year

Biopsy sites

Where applicable, the sampling site should be coded. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_biopsieentnahm
  Data type: String with following options
    left ventricle
    right ventricle
    left and right ventricle
    unkown
    not assessed

Current secondary diagnoses

PAOD

PAOD**

is defined as a current or previous diagnosis by a doctor of peripheral arterial occlusive disease (in the blood vessels of the pelvis and legs, or from the upper extremity of the subclavian artery to the distal extremity). Renal, coronary, cerebral and mesenteric blood vessels and aneurysms are excluded. Possible symptoms are:
  • intermittent claudication,
  • amputation due to severe arterial vascular insufficiency,
  • vascular reconstruction, bypass operation or percutaneous revascularization,
  • a positive non-invasive test (e.g. ankle-brachial index of ≤ 0.9, pathological TCPO2 measurement, evidence of 50 % or greater stenosis of a peripheral artery by Doppler/duplex sonography, CT, MRT, or angiography).
DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_pavk
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by PAOD

Fontaine stage

Classification of the degree of severity is done according to the Fontaine classification:
  • Stage I: Asymptomatic PAOD
  • Stage II: Intermittent claudication
    • with walking distances > 200 metres (Stage IIa)
    • with walking distances < 200 metres (Stage IIb)
  • Stage III: Pain at rest
  • Stage IV: Necrosis, gangrene
    • trophic disorder, dry necroses (Stage IVa)
    • bacterial infection of the necrosis, wet gangrene (Stage IVb)
    • DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_pavk_font
  Data type: String with following options
    I
    IIa
    IIb
    III
    IV
    unkown
    not assessed

Acute ischaemic occlusion

Acute ischaemic occlusion describes a recent (in the last 30 days) occurrence of demonstrated acute ischaemic occlusion of a peripheral arterial vessel. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_pavk_isch
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Stroke/TIA

Stroke/TIA**

is defined as a current or previous diagnosis by a doctor. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_schlagtia
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by stroke/TIA

Date

  Fieldname: basis_schlag_date
  Data type: Timestamp with month and year

Aetiology and Diagnosis

  • Ischaemic stroke: Infarction of tissue of the central nervous system, either symptomatic or silent (asymptomatic).
  • Transient ischaemic attack (TIA): A transient episode of neurological dysfunction caused by focal brain, spinal cord or retinal ischaemia without acute infarction which resolves completely within 24 hours. This definition is not met by chronic (non-vascular) neurological diseases or other acute neurological diseases such as metabolic or ischaemic encephalopathy resulting from general hypoxia (e.g. in the case of respiratory insufficiency, following a cardiac/circulatory arrest).
  • Haemorrhagic stroke: Neurological dysfunction caused by intra-cranial bleeding.
  • Stroke where there is uncertainty as to whether the cause was haemorrhagic or ischaemic.
DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_schlagaetiolog
  Data type: String with following options
    ischaemic
    haemorrhagic
    unkown
    not assessed
  Fieldname: basis_schlagdiag
  Data type: String with following options
    TIA
    stroke
    unkown
    not assessed

Stroke severity

A stroke is described as “minor“ when the neurological symptoms can be completely reversed within 30 days or the change in the NIH Stroke Scale (see Appendix 7.3 NIH Stroke Scale) amounts to less than 3 points in comparison with the NIH Stroke Scale before the stroke. A stroke is described as “major” when a neurological deficit can still be demonstrated 30 days after the event or the NIH Stroke Scale is at least 3 points higher than prior to the stroke. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_schlagschwer
  Data type: String with following options
    minor
    major
    unkown
    not assessed

Consequences of the stroke

A stroke is described as “disabling” when more than 2 points are scored on modified Rankin Scale 90 days after the stroke. If the modified Rankin Scale score is 2 points or less 90 days after the stroke, the stroke is described as “non-disabling”. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_schlagfolge
  Data type: String with following options
    disabling
    non-disabling
    unkown
    not assessed

Chronic lung disease**

is defined as a diagnosis by a doctor of a chronic lung disease (e.g. COPD, chronic bronchitis, pulmonary fibrosis) and/or their pharmacological treatment, for example, with inhalable or oral pharmaceuticals. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_copd
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by chronic lung disease

Primary pulmonary hypertension

is defined as a diagnosis and/or treatment by a doctor of primary pulmonary hypertension. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_pulhyper
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Depression**

is defined as a current or previous diagnosis by a doctor. The administration of antidepressants alone does not qualify for a diagnosis of depression. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_depressions
  Note in CRF: If the response to this question is “yes”, please complete the “Depression” form.
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by depression

Cancer more than 5 years ago**

is defined as a current or previous diagnosis of a malignant cancer. Basal cell carcinoma does not belong to malignancy. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_malignom
  Note in CRF: Malignom
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by cancer(5Y+)

Cancer within the last 5 years**

  Fieldname: basis_malignom_w5j
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by cancer(
		
			

Anamnestic questions for women only

Menopause**

  Fieldname: basis_meno
  Data type: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by menopause

Year of Menopause**

  Fieldname: basis_menojahr
  Data type: Timestamp with year

Day last menstrual period began**

  Fieldname: basis_regeldat
  Data type: Timestamp with year, month and day

Blood pressure after 5 minutes at rest

Systolic**

The systolic blood pressure should be measured using a blood pressure monitor that is serviced and calibrated on a regular basis. Where possible, tested devices (e.g. Omron 705 IT) should be used for epidemiological trials. Blood pressure measurement begins after the patient has been at rest for at least 5 minutes. Three readings are taken at intervals of 2 minutes; the average values of the second and third readings are entered into the CRF. DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_systol
  Note in CRF: Systolic
  Data type: Integer with 3 decimal places
  Figure: Number of records by systolic blood pressure in mm Hg

Diastolic**

  Feldname: basis_diastol
  Note in CRF: Diastolic
  Data type: Integer with 3 decimal places
  Figure: Number of records by diastolic blood pressure in mm Hg

Heart rate after sitting down for 5 minutes **

Measurement of the heart rate begins after the patient has been sitting down for at least 5 minutes. This should take place after measuring the blood pressure. This should be done manually by counting the radial pulse for 30 seconds; that value multiplied by two should be entered into the CRF (beats/minute). DZHK-SOP-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_frequenz
  Note in CRF: Heart rate
  Data type: Integer with 3 decimal points
  Figure: Number of records by heart rate

Further diagnoses

Dyspnoea on exertion

A patient who complains of shortness of breath with physical exertion within the last 14 days and/or at present. In cases of known heart failure, for patients in NYHA stages II-IV, dyspnoea on exertion should be coded. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_bdyspnoe
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Dyspnoea at rest

A patient who complains of shortness of breath even when at rest (e.g. when talking) within the last 14 days and/or aatpresent. In cases of known heart failure, for patients in NYHA stage IV, dyspnoea at rest should be coded. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_rdyspnoe
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Peripheral oedema

A patient who complains of bilateral accumulation of fluid in the extremities within the last 14 days and/or at present, whether clinically observed or perceived by the patient. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_oedeme1
   Data type: String with following options
    yes
    no
    unkown
    not assessed

Jugular venous distention

The diagnostic test for jugular venous distention is conducted with the upper body of the patient positioned at a 45° angle. The level at which the jugular vein collapses is then determined. A non-pathological finding is if the vein collapses at latest at the level of the supra-sternal notch, which normally corresponds to an 8 cm water column or 5-6 mmHg before the right atrium. If the jugular vein collapses above the supra-sternal notch, jugular venous distention must be coded. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_halsvene
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Pulmonary rales

are defined as sounds heard over the lung during auscultation which are created by the movement of fluids and/or secretions during inspiration and expiration. They belong to the category of adventitious breath sounds overlying normal breath sounds and indicate a pathological change in the lung. DZHK-SOP-K-02: Anamnesis/Clinical Diagnoses, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_pulmo
  Data type: String with following options
    yes
    no
    unkown
    not assessed

Laboratory diagnostics (blood)

  Note in CRF: For clinically stable patients, not more than 1 week old, otherwise up to date!

Date of blood sample was taken**

  Fieldname: basis_blut
  Note in CRF: Where applicable, give date for the oldest value.
  Data type: Timestamp with year, month and day

Haemoglobin**

  Fieldname: basis_haemo
  Data type: Floating point number with 2 decimal places and 2 places after comma 
  Figure: Number of records by haemoglobin

Creatinine (serum, heparin plasma)**

  Fieldname: basis_kreatinin
  Data type: Floating point number with 4 decimal places and 3 places after comma
  Figure: Number of records by creatinine

Total cholesterol**

  Fieldname: basis_choles
  Data type: Integer with 4 decimal places
  Figure: Number of records by total cholesterol