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 year, month and day
  Figure: Number of records cumulatively by date of invastigation

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 year and month
  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 three decimal places
  Figure: Number of records by height in centimetre
  Fieldname: basis_gewicht
  Note in CRF: Weight
  Data Type: Integer with three 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
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

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-K02: Basic data set - Anamnesis/Clinical Diagnoses/Physical Examination, Version: V1.0, Valid as of: 01.09.2014
  Fieldname: basis_raucher
  Note in CRF: Smoker
  Datentyp: String with following options
    yes
    no
    ex-smoker (stopped ≥ 6 mth. ago)
    unkown
    not assessed
  Figure: Number of records by smoker
  Fieldname: basis_exrauch
  Note in CRF: Ex-smoker since
  Data Type: Timestamp with year

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
  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

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

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 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

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

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

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
  Feldname: basis_herzklap_op
  Datentyp: String with following options
    yes
    no
    unkown
    not assessed
  Figure: Number of records by heart valve operation

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

Current secondary diagnoses

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

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

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

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
  Datentyp: Integer with 3 decimal points
  Figure: Number of records by heart rate

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 digits after decimal point 
  Figure: Number of records by haemoglobin

Creatinine (serum, heparin plasma)

  Fieldname: basis_kreatinin
  Data Type: Floating point number with 4 decimal places and 3 digits after decimal point
  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