Clinical Trial Details

NCT ID: NCT02594488
Date Last Changed: October 9, 2017

Overview

Research Study Summary

A clinical research study of Medtronic Reveal LINQ implantable cardiac monitor for the treatment of Myocardial Infarction or Autonomic Nervous System Diseases

Research Study Title

Implantable Cardiac Monitors in High-risk Post-infarction Patients With Cardiac Autonomic Dysfunction and Moderately Reduced Left Ventricular Ejection Fraction

Purpose

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.

To Learn more

Recruitment Details

Gender
All
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Klinikum der Universitaet Muenchen
Duration
27 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 80 Years

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Site Locations (16)

Country State City Zip Facility and Contact
Germany Baden-Württemberg Karlsruhe 76133 Städtisches Klinikum Karlsruhe, Medizinische Klinik IV
Claus Schmitt, MD
+49 721 974 ext. 2901
kardiologie@klinikum-karlsruhe.de

Armin Luik, MD
Principal Investigator
Germany Baden-Württemberg Tübingen 72076 Universitätsklinikum Tübingen, Medizinische Klinik III
Meinrad P Gawaz, MD
+49 7071 29 ext. 8 36 88
meinrad.gawaz@med.uni-tuebingen.de

Christine Meyer-Zürn, MD
Principal Investigator
Germany Bayern Munich 81377 Klinikum der Universität München
Axel Bauer, MD
+4989440076090
axel.bauer@med.uni-muenchen.de

Axel Bauer, MD
Principal Investigator
Germany Bayern München 81675 Technische Universität München, Medizinische Klinik und Poliklinik I
Karl-Ludwig Laugwitz, MD
+49 89 4140 ext. 2350
sekretariat-laugwitz@mytum.de

Daniel Sinnecker, D
Principal Investigator
Germany Bayern Regensburg 93053 Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II
Lars Meier, MD
0941 944-7210
Corinna.Schreiner@ukr.de

Lars Meier, MD
Principal Investigator
Germany NRW Wuppertal 42117 HELIOS Herzzentrum Wuppertal, Klinik für Kardiologie
Melchior Seyfarth, MD
(0202) 896-57 08/10
melchior.seyfarth@helios-kliniken.de

Till Köhler, MD
Principal Investigator
Germany Saarland Homburg 66421 Universitätsklinikum des Saarlandes, Medizinische Klinik III
Michael Böhm, MD
+496841/16 ext. 21346
michael.boehm@uniklinikum-saarland.de

Christian Ukena, MD
Principal Investigator
Germany Berlin 12200 Universitätsmedizin Berlin, Klinik für Kardiologie, Charite, Campus Benjamin Franklin
Ulf Landmesser, MD

Verena Tscholl, MD
Principal Investigator
Germany Berlin 13353 Universitätsmedizin Berlin, Klinik für Kardiologie, Charite, Campus Virchow Kinikum
Burkert Pieske, MD
+49 30 450 553 ext. 702
burkert.pieske@charite.de

Florian Blaschke, MD
Principal Investigator
Germany Greifswald 17475 Universitätsmedizin Greifswald, Klinik für Innere Medizin B
Stefan Felix, MD
felix@uni-greifswald.de

Mathias Busch, MD
Principal Investigator
Germany Göttingen Universitätsmedizin Göttingen, Klinikum für Kardiologie und Pneumologie
Markus Zabel, MD

Markus Zabel, MD
Principal Investigator
Germany Hamburg 20099 Asklepios Klinik St. Georg, Abteilung für Kardiologie
Karl-Heinz Kuck, MD
+49 40 18 18-85 ext. 23 25
k.kuck@asklepios.com

Tobias Tönnis, MD
Principal Investigator
Germany Hamburg 20251 Universitäres Herzzentrum Hamburg GmbH
Stephan Willems, MD
+49 40/ 7410-52438
willems@uke.de

Christian Meyer, MD
Principal Investigator
Germany Kiel 24105 Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III
Hendrik Bonnemeier, MD
hendrik.bonnemeier@uksh.de

Matthias Lutz, MD
Principal Investigator
Germany Leipzig 04289 Leipzig Heart Institute GmbH
Gerhard Hindricks, MD
+49 341 865 ext. 1592
gerhard.hindricks@leipzig-hear.de

Gerhard Hindricks, MD
Principal Investigator
Germany Lübeck 23538 Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik II
Holger Thiele, MD
+49 451 / 500 ext. 2501
hzl@uksh.de

Roland Tilz, MD
Principal Investigator

Contact

Axel Bauer, MD
+4989440076090
E-mail:

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