- Recruiting status
- Recruitment start
- Clinical Trials Registration
Early clinical study
- DZHK Funding
Main study centre - Lukas von Stülpnagel
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.
Bauer A. et al.: Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial.; SMART-MI-DZHK9 investigators. Lancet Digit Health. 2022 Feb; 4(2):e105-e116, doi: 10.1016/S2589-7500(21)00253-3
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. et al.: 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. et al.: 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 investigator: Axel Bauer (München und Insbruck, AT), Co-PI: Stefan Kääb, Steffen Massberg (München)
Press releases and news
Implanted heart monitor can predict life-threatening complications after heart attack (Study SMART-MI-DZHK9)
After a heart attack, an implanted heart monitor can better detect those at risk of serious...
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...
Study recruitment is available in these cities
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