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SMART-MI-DZHK9


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.

Principal Investigators
Axel Bauer, Stefan Kääb, Steffen Massberg (München)

Medical institution
Klinikum der Universität München

Keywords
implantable cardiac monitor, autonomic nervous system, myocardial infarction

Start of recruitment
05/2016

Study participants (planned)
400 (+ 1200 registry)

Study participants (recruited)
364 (+ 852 registry)

ClinicalTrials.gov

Category
Early clinical study

Status
DZHK study

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