SMART-MI-DZHK9


Study information
SMART-MI-DZHK9

Recruiting status

Recruiting complete, follow-up complete

Recruitment start

05/2016

Patients

401

400

Clinical Trials Registration

NCT02594488

Category

Early clinical study

DZHK Funding

EUR 2.126.096,51

Links

https://smart-mi.dzhk.de/

Operative contact:
Main study centre - Lukas von Stülpnagel
smart-mi@med.uni-muenchen.de

Studienzentren/Kontakt (PDF)

Implantable cardiac monitors in high-risk post-infarction patients with cardiac autonomic dysfunction (SMART-MI-DZHK9)

Sudden cardiac death is among the leading causes of death in the industrialized world. Survivors of myocardial infarction (MI) are at increased risk of death. Current guideline recommendations only consider patients with a highly reduced left ventricular ejection fraction (LVEF <35%) for prophylactic ICD (implantable cardioverter defibrillator) implantation. However, the majority of cardiac deaths after MI occur in patients with preserved LVEF (>35%). These patients are currently not considered by guideline recommendations.

There is a large body of evidence that an imbalance of the cardiac autonomic nervous system (ANS) is associated with an increased risk of life-threatening arrhythmias (including sudden cardiac death). The research group of Prof. Axel Bauer developed two new ECG-based risk parameters, deceleration capacity of heart rate (DC) and periodic repolarization dynamics (PRD), which reflect different facets of autonomic nervous system activity. The prognostic information of a combined use of both parameters identifies a new high-risk group of post-MI patients with preserved LVEF which has the same poor prognosis as the “classical” high-risk patients with a highly reduced LVEF.

In SMART-MI, the DZHK research group of Munich tests whether the use of implantable cardiac monitors (ICMs) with home monitoring function is more effective than conventional follow-up for detecting serious arrhythmic events in the newly identified high-risk group of patients described above. The effect of an ICM-guided therapy on clinical events is tested as secondary endpoint.

Publications

Bauer A.: Identifying high-risk post-infarction patients by autonomic testing - Below the tip of the iceberg. Int J Cardiol. 2017 Jun 15;237:19-21. doi: 10.1016/j.ijcard.2017.03.087. Epub 2017 Mar 18.

Hamm W, Rizas KD, Stülpnagel LV, Vdovin N, Massberg S, Kääb S, Bauer A.: Implantable cardiac monitors in high-risk post-infarction patients with cardiac autonomic dysfunction and moderately reduced left ventricular ejection fraction: Design and rationale of the SMART-MI trial. Am Heart J. 2017 Aug;190:34-39. doi: 10.1016/j.ahj.2017.05.006. Epub 2017 May 19.

Rizas KD, Hamm W, Kääb S, Schmidt G, Bauer A.: Periodic Repolarisation Dynamics: A Natural Probe of the Ventricular Response to Sympathetic Activation. Arrhythm Electrophysiol Rev. 2016 May;5(1):31-6. doi: 10.15420/aer.2015:30:2.

All publications of the trial can be found here.

Principal Investigators

Prof. Dr. Axel Bauer
Klinikum der Universität München/ Universitätsklinik für Innere Medizin III Innsbruck
Prof. Dr. Steffen Massberg
Klinikum der Universität München / Klinikum Großhadern
Prof. Dr. Stefan Kääb
Klinikum der Universität München / Klinikum Großhadern

Press releases and news

DZHK Study: Insertable monitor should provide greater protection following myocardial infarction

A small insertable monitor could flag impending complications such as cardiac arrhythmias in certain...

München,Kiel,Tübingen,Leipzig,Berlin,Greifswald,Hamburg,Lübeck,Göttingen,Homburg,Karlsruhe,Regensburg,Wuppertal,Dresden,Essen,Münster,Aachen,Mainz,Wiesbaden,Mannheim,Heidelberg,Bernried,Füssen,Nürnberg,Weiden i.d. O

Study recruitment is available in these cities