Implantable Cardiac Monitors in High-Risk Post-Infarction Patients With Cardiac Autonomic Dysfunction
- Conditions
- Myocardial InfarctionAutonomic Nervous System Diseases
- Interventions
- Device: Medtronic Reveal LINQ implantable cardiac monitor
- Registration Number
- NCT02594488
- Lead Sponsor
- LMU Klinikum
- Brief Summary
The majority of deaths after myocardial infarction occurs in patients with preserved left ventricular ejection fraction (\>35%) for whom no prophylactic strategies exist. Periodic Repolarization Dynamics (PRD) and Deceleration Capacity (DC) of heart rate are autonomic risk markers that identify a new high risk group of patients with LVEF 35-50% who have the same poor prognosis as patients with LVEF ≤35%.
In SMART-MI, post-infarction patients with LVEF 35-50% and abnormal PRD and/or DC will be randomly assigned to biomonitoring-guided therapy or conventional follow-up.
- Detailed Description
Sudden cardiac death (SCD) is the most common single cause of death in the industrialized world. Patients after myocardial infarction (MI) are at increased risk of SCD. Current guidelines recommend prophylactic ICD-implantation in post-MI patients with reduced left ventricular ejection fraction (LVEF ≤35%). However, the majority of arrhythmic deaths after MI occurs in patients with LVEF \>35% in whom no specific prophylactic strategies exist, indicating an important unmet medical need.
There is a large body of evidence that presence of cardiac autonomic dysfunction after MI is associated with an increased susceptibility to malignant brady- and tachyarrhythmias eventually culminating in SCD. Periodic repolarization dynamics (PRD) and heart rate deceleration capacity (DC) are clinically validated autonomic risk markers that provide strong and independent prognostic information in post-MI patients with LVEF \>35%. PRD and DC reflect different facets of autonomic function and can therefore be used in combination to predict risk. Previous studies demonstrated that combined assessment of PRD and DC identifies a new high-risk group among post-MI patients with moderately reduced LVEF (36-50%). This new high-risk group has similar characteristics with respect to prognosis and patient numbers as the established high-risk group identified by LVEF ≤35%.
However, the exact mechanisms leading to death in this new high-risk group need to be investigated in order to develop specific preventive strategies. As known from studies with implantable cardiac monitors (ICM) in post-MI patients with LVEF ≤40% eventual death is often preceded by primarily asymptomatic serious arrhythmic events. These data suggest a potential time frame for pre-emptive interventions in case of arrhythmic events, which could improve outcome.
Therefore, SMART-MI will assess the occurrence and prognostic implications of serious arrhythmic events in this newly identified high-risk group by remote monitoring with ICM. Survivors of acute MI (\<40 days) and LVEF 36-50% undergo autonomic testing for presence of abnormal PRD and/or DC. Those with autonomic dysfunction will be randomly assigned to ICM-implantation or conventional follow-up. Superiority of ICMs in detection of predefined serious arrhythmic events will be tested based on a time-to-event analysis. A central ICM core lab will be implemented allowing for a response to arrhythmias within 48h. The effect of remote monitoring on clinical outcomes will be tested as secondary endpoints. The study will provide the rationale for a future guideline-relevant study testing prophylactic therapies in this newly identified high-risk group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Acute myocardial infarction <40 days
- Left ventricular ejection fraction 36-50%
- Presence of cardiac autonomic dysfunction by means of abnormal periodic repolarization dynamics and/or abnormal deceleration capacity
- Age 18-80 years
- Sinus rhythm
- Optimal medical therapy
- ICD or pacemaker indication
- Known paroxysmal or persistent atrial fibrillation
- Life expectancy < 12 months
- Inability to comply with follow-up
- Pregnancy
- Participation in another trial that may interfere
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remote monitoring Medtronic Reveal LINQ implantable cardiac monitor Remote cardiac monitoring by the Reveal® LINQ implantable cardiac monitor
- Primary Outcome Measures
Name Time Method Detection of serious arrhythmic events 18 months Time to detection of one of the following serious arrhythmic events: atrial fibrillation ≥6 min, higher degree AV-block ≥ IIb, ventricular tachycardia with a cycle length ≤320ms lasting for ≥12 sec (corresponding to 40 beats), sustained ventricular tachycardia and ventricular fibrillation
- Secondary Outcome Measures
Name Time Method Cardiovascular mortality 18 months Time to cardiovascular death
Sinus arrest >6sec 18 months Time to detection of sinus arrest \>6sec
Higher degree AV-block ≥ IIb 18 months Time to detection of higher degree AV-block ≥ IIb
All cause mortality 18 months Time to death
Unplanned hospitalizations for decompensated heart failure 18 months Time to unplanned hospitalizations for decompensated heart failure
Non-sustained ventricular tachycardia 18 months Time to detection of ventricular tachycardia with a cycle length ≤320ms lasting for ≥12 sec
Composite of all-cause mortality, stroke, systemic arterial thromboembolism and unplanned hospitalizations for decompensated heart failure 18 months Time to one of following clinical events: death, stroke, systemic arterial thromboembolism and unplanned hospitalization for decompensated heart failure
Sustained ventricular tachycardia / ventricular fibrillation 18 months Time to detection of sustained ventricular tachycardia / ventricular fibrillation
Atrial fibrillation ≥6 min 18 months Time to detection of atrial fibrillation ≥6 min
Trial Locations
- Locations (32)
Städtisches Klinikum Karlsruhe, Medizinische Klinik IV
🇩🇪Karlsruhe, Baden-Württemberg, Germany
Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III
🇦🇹Innsbruck, Austria
Klinikum der Universität München
🇩🇪Munich, Bayern, Germany
Universitätsklinikum Tübingen, Medizinische Klinik III
🇩🇪Tübingen, Baden-Württemberg, Germany
HELIOS Herzzentrum Wuppertal, Klinik für Kardiologie
🇩🇪Wuppertal, NRW, Germany
Universitätsklinikum des Saarlandes, Medizinische Klinik III
🇩🇪Homburg, Saarland, Germany
Herzzentrum Dresden, Univeristätsklinik an der TU Dresden
🇩🇪Dresden, Germany
Klinik Höhenried, Rehabilitationszentrum am Starnberger See
🇩🇪Bernried, Germany
Universitätsmedizin Göttingen, Klinikum für Kardiologie und Pneumologie
🇩🇪Göttingen, Germany
Universtitätsklinikum der RWTH Aachen, Medizinische Klinik I
🇩🇪Aachen, Germany
Universitätsmedizin Berlin, Klinik für Kardiologie, Charite, Campus Virchow Kinikum
🇩🇪Berlin, Germany
Universitätsmedizin Greifswald, Klinik für Innere Medizin B
🇩🇪Greifswald, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsmedizin Mainz
🇩🇪Mainz, Germany
Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Klinikum Nürnberg
🇩🇪Nürnberg, Germany
Asklepios Klinik St. Georg, Abteilung für Kardiologie
🇩🇪Hamburg, Germany
Universitäres Herzzentrum Hamburg GmbH
🇩🇪Hamburg, Germany
Leipzig Heart Institute GmbH
🇩🇪Leipzig, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III
🇩🇪Kiel, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik II
🇩🇪Lübeck, Germany
Kliniken Nordoberpfalz AG, Klinikum Weiden
🇩🇪Weiden, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Klinikum Neuperlach, Städtisches Klinikum München GmbH
🇩🇪München, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Technische Universität München, Medizinische Klinik und Poliklinik I
🇩🇪München, Bayern, Germany
Universitätsmedizin Berlin, Klinik für Kardiologie, Charite, Campus Benjamin Franklin
🇩🇪Berlin, Germany
Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen
🇩🇪Füssen, Germany
Universitätklinikum Essen, Klinik für Kardiologie und Angiologie
🇩🇪Essen, Germany
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
🇩🇪München, Germany
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II
🇩🇪Regensburg, Bayern, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
St. Josefs-Hospital Wiesbaden
🇩🇪Wiesbaden, Germany