Last updated on August 2018

Implantable Cardiac Monitors in High-Risk Post-Infarction Patients With Cardiac Autonomic Dysfunction

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02594488

Contact Investigators or Research Sites near you

Start Over

Armin Luik, MD

St dtisches Klinikum Karlsruhe, Medizinische Klinik IV
Karlsruhe, Germany
  Connect »

Axel Bauer, MD

Klinikum der Universit t M nchen
Munich, Germany
  Connect »

Lars Meier, MD

Universit tsklinikum Regensburg, Klinik und Poliklinik f r Innere Medizin II
Regensburg, Germany
  Connect »

Till Köhler, MD

HELIOS Herzzentrum Wuppertal, Klinik f r Kardiologie
Wuppertal, Germany
  Connect »

Christian Ukena, MD

Universit tsklinikum des Saarlandes, Medizinische Klinik III
Homburg, Germany
  Connect »

Verena Tscholl, MD

Universit tsmedizin Berlin, Klinik f r Kardiologie, Charite, Campus Benjamin Franklin
Berlin, Germany
  Connect »

Florian Blaschke, MD

Universit tsmedizin Berlin, Klinik f r Kardiologie, Charite, Campus Virchow Kinikum
Berlin, Germany
  Connect »

Mathias Busch, MD

Universit tsmedizin Greifswald, Klinik f r Innere Medizin B
Greifswald, Germany
  Connect »

Tobias Tönnis, MD

Asklepios Klinik St. Georg, Abteilung f r Kardiologie
Hamburg, Germany
  Connect »

Christian Meyer, MD

Universit res Herzzentrum Hamburg GmbH
Hamburg, Germany
  Connect »

Matthias Lutz, MD

Universit tsklinikum Schleswig-Holstein, Campus Kiel, Klinik f r Innere Medizin III
Kiel, Germany
  Connect »

Gerhard Hindricks, MD

Leipzig Heart Institute GmbH
Leipzig, Germany
  Connect »

Andreas Napp, MD

Universtit tsklinikum der RWTH Aachen, Medizinische Klinik I
Aachen, Germany
  Connect »

Christa Bongarth, MD

Klinik H henried, Rehabilitationszentrum am Starnberger See
Bernried, Germany
  Connect »

Johannes Siebermair, MD

Universit tklinikum Essen, Klinik f r Kardiologie und Angiologie
Essen, Germany
  Connect »

Christine Meyer-Zürn, MD

Universit tsklinikum T bingen, Medizinische Klinik III
Tübingen, Germany
  Connect »

Daniel Sinnecker, D

Technische Universit t M nchen, Medizinische Klinik und Poliklinik I
München, Germany
  Connect »

Axel Linke, MD

Herzzentrum Dresden, Univerist tsklinik an der TU Dresden
Dresden, Germany
  Connect »

Martin Hintersser, MD

Kliniken Ostallg u-Kaufbeuren, Klinik F ssen
Füssen, Germany
  Connect »

Markus Zabel, MD

Universit tsmedizin G ttingen, Klinikum f r Kardiologie und Pneumologie
Göttingen, Germany
  Connect »

Rolf Wachter, MD

Universit tsklinikum Leipzig
Leipzig, Germany
  Connect »

Roland Tilz, MD

Universit tsklinikum Schleswig-Holstein, Campus L beck, Medizinische Klinik II
Lübeck, Germany
  Connect »

Jürgen Kuschyk, MD

Universit tsklinikum Mannheim
Mannheim, Germany
  Connect »

Michael Joner, MD

Deutsches Herzzentrum M nchen, Klinik f r Herz- und Kreislauferkrankungen
München, Germany
  Connect »

Harald Mudra, PI

Klinikum Neuperlach, St dtisches Klinikum M nchen GmbH
München, Germany
  Connect »

Lars Eckardt, MD

Universit tsklinikum M nster
Münster, Germany
  Connect »

Matthias Pauschinger, MD

Universit tsklinik der Paracelsus Medizinischen Privatuniversit t, Klinikum N rnberg
Nürnberg, Germany
  Connect »

Robert Schwinger, MD

Kliniken Nordoberpfalz AG, Klinikum Weiden
Weiden, Germany
  Connect »

Joachim Ehrlich, MD

St. Josefs-Hospital Wiesbaden
Wiesbaden, Germany
  Connect »

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.