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Implantable Cardiac Monitors in High-Risk Post-Infarction Patients With Cardiac Autonomic Dysfunction (SMART-MI)

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ClinicalTrials.gov Identifier: NCT02594488
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Axel Bauer, Klinikum der Universitaet Muenchen

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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Autonomic Nervous System Diseases Device: Medtronic Reveal LINQ implantable cardiac monitor Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Implantable Cardiac Monitors in High-risk Post-infarction Patients With Cardiac Autonomic Dysfunction and Moderately Reduced Left Ventricular Ejection Fraction
Actual Study Start Date : May 6, 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Remote monitoring
Remote cardiac monitoring by the Reveal® LINQ implantable cardiac monitor
Device: Medtronic Reveal LINQ implantable cardiac monitor
The implantable cardiac monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. Predefined arrhythmias are daily transmitted to a central core lab. In case of arrhythmias, specific guideline-based treatment is initiated within 48h.

No Intervention: Control arm
Follow-up at the same frequency, but with no implantable cardiac monitor



Primary Outcome Measures :
  1. Detection of serious arrhythmic events [ Time Frame: 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 :
  1. Composite of all-cause mortality, stroke, systemic arterial thromboembolism and unplanned hospitalizations for decompensated heart failure [ Time Frame: 18 months ]
    Time to one of following clinical events: death, stroke, systemic arterial thromboembolism and unplanned hospitalization for decompensated heart failure

  2. All cause mortality [ Time Frame: 18 months ]
    Time to death

  3. Cardiovascular mortality [ Time Frame: 18 months ]
    Time to cardiovascular death

  4. Unplanned hospitalizations for decompensated heart failure [ Time Frame: 18 months ]
    Time to unplanned hospitalizations for decompensated heart failure

  5. Sinus arrest >6sec [ Time Frame: 18 months ]
    Time to detection of sinus arrest >6sec

  6. Atrial fibrillation ≥6 min [ Time Frame: 18 months ]
    Time to detection of atrial fibrillation ≥6 min

  7. Higher degree AV-block ≥ IIb [ Time Frame: 18 months ]
    Time to detection of higher degree AV-block ≥ IIb

  8. Non-sustained ventricular tachycardia [ Time Frame: 18 months ]
    Time to detection of ventricular tachycardia with a cycle length ≤320ms lasting for ≥12 sec

  9. Sustained ventricular tachycardia / ventricular fibrillation [ Time Frame: 18 months ]
    Time to detection of sustained ventricular tachycardia / ventricular fibrillation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594488


Contacts
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Contact: Axel Bauer, MD +4989440076090 axel.bauer@med.uni-muenchen.de
Contact: Wolfgang Hamm, MD +4989440072371 wolfgang.hamm@med.uni-muenchen.de

Locations
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Austria
Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III Not yet recruiting
Innsbruck, Austria, 6020
Contact: Markus Stühlinger, MD       markus.stuehlinger@tirol-kliniken.at   
Principal Investigator: Markus Stuehlinger, MD         
Germany
Städtisches Klinikum Karlsruhe, Medizinische Klinik IV Recruiting
Karlsruhe, Baden-Württemberg, Germany, 76133
Contact: Claus Schmitt, MD    +49 721 974 ext 2901    kardiologie@klinikum-karlsruhe.de   
Principal Investigator: Armin Luik, MD         
Universitätsklinikum Tübingen, Medizinische Klinik III Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Meinrad P Gawaz, MD    +49 7071 29 ext 8 36 88    meinrad.gawaz@med.uni-tuebingen.de   
Principal Investigator: Christine Meyer-Zürn, MD         
Klinikum der Universität München Recruiting
Munich, Bayern, Germany, 81377
Contact: Axel Bauer, MD    +4989440076090    axel.bauer@med.uni-muenchen.de   
Contact: Konstantinos D Rizas, MD    +4989440073068    konstantinos.rizas@med.uni-muenchen.de   
Principal Investigator: Axel Bauer, MD         
Technische Universität München, Medizinische Klinik und Poliklinik I Recruiting
München, Bayern, Germany, 81675
Contact: Karl-Ludwig Laugwitz, MD    +49 89 4140 ext 2350    sekretariat-laugwitz@mytum.de   
Principal Investigator: Daniel Sinnecker, D         
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II Recruiting
Regensburg, Bayern, Germany, 93053
Contact: Lars Meier, MD    0941 944-7210    Corinna.Schreiner@ukr.de   
Principal Investigator: Lars Meier, MD         
HELIOS Herzzentrum Wuppertal, Klinik für Kardiologie Recruiting
Wuppertal, NRW, Germany, 42117
Contact: Melchior Seyfarth, MD    (0202) 896-57 08/10    melchior.seyfarth@helios-kliniken.de   
Principal Investigator: Till Köhler, MD         
Universitätsklinikum des Saarlandes, Medizinische Klinik III Recruiting
Homburg, Saarland, Germany, 66421
Contact: Michael Böhm, MD    +496841/16 ext 21346    michael.boehm@uniklinikum-saarland.de   
Principal Investigator: Christian Ukena, MD         
Universtitätsklinikum der RWTH Aachen, Medizinische Klinik I Recruiting
Aachen, Germany, 52074
Contact: Dirk Müller-Wieland, MD    +49 241 80 ext 35227    dirmueller@ukaachen.de   
Principal Investigator: Andreas Napp, MD         
Universitätsmedizin Berlin, Klinik für Kardiologie, Charite, Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Ulf Landmesser, MD         
Principal Investigator: Verena Tscholl, MD         
Universitätsmedizin Berlin, Klinik für Kardiologie, Charite, Campus Virchow Kinikum Recruiting
Berlin, Germany, 13353
Contact: Burkert Pieske, MD    +49 30 450 553 ext 702    burkert.pieske@charite.de   
Principal Investigator: Florian Blaschke, MD         
Klinik Höhenried, Rehabilitationszentrum am Starnberger See Recruiting
Bernried, Germany, 82347
Contact: Christa Bongarth, MD    +49 8158 ext 32000    christa.bongarth@hoehenried.de   
Principal Investigator: Christa Bongarth, MD         
Herzzentrum Dresden, Univeristätsklinik an der TU Dresden Recruiting
Dresden, Germany, 01307
Contact: Axel Linke, MD    0351 450 ext 25231    axel.linke@tu-dresden.de   
Principal Investigator: Axel Linke, MD         
Universitätklinikum Essen, Klinik für Kardiologie und Angiologie Recruiting
Essen, Germany, 45122
Contact: Tienush Rassaf, MD    +49 201 723 ext 4801    tienush.rassaf@uk-essen.de   
Principal Investigator: Johannes Siebermair, MD         
Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen Recruiting
Füssen, Germany, 87629
Contact: Martin Hinterseer, MD    08362 500 ext 362    martin.hinterseer@kliniken-oal-kf.de   
Principal Investigator: Martin Hintersser, MD         
Universitätsmedizin Greifswald, Klinik für Innere Medizin B Recruiting
Greifswald, Germany, 17475
Contact: Stefan Felix, MD       felix@uni-greifswald.de   
Principal Investigator: Mathias Busch, MD         
Universitätsmedizin Göttingen, Klinikum für Kardiologie und Pneumologie Recruiting
Göttingen, Germany
Contact: Markus Zabel, MD         
Principal Investigator: Markus Zabel, MD         
Asklepios Klinik St. Georg, Abteilung für Kardiologie Recruiting
Hamburg, Germany, 20099
Contact: Karl-Heinz Kuck, MD    +49 40 18 18-85 ext 23 25    k.kuck@asklepios.com   
Principal Investigator: Tobias Tönnis, MD         
Universitäres Herzzentrum Hamburg GmbH Recruiting
Hamburg, Germany, 20251
Contact: Stephan Willems, MD    +49 40/ 7410-52438    willems@uke.de   
Principal Investigator: Christian Meyer, MD         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Hugo Katus, MD         
Principal Investigator: Edgar Zitron, MD         
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III Recruiting
Kiel, Germany, 24105
Contact: Hendrik Bonnemeier, MD       hendrik.bonnemeier@uksh.de   
Principal Investigator: Matthias Lutz, MD         
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Ulrich Laufs, MD    0341 971 ext 2408    ulrich.laufs@medizin.uni-leipzig.de   
Principal Investigator: Rolf Wachter, MD         
Leipzig Heart Institute GmbH Recruiting
Leipzig, Germany, 04289
Contact: Gerhard Hindricks, MD    +49 341 865 ext 1592    gerhard.hindricks@leipzig-hear.de   
Principal Investigator: Gerhard Hindricks, MD         
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik II Recruiting
Lübeck, Germany, 23538
Contact: Holger Thiele, MD    +49 451 / 500 ext 2501    hzl@uksh.de   
Principal Investigator: Roland Tilz, MD         
Universitätsmedizin Mainz Recruiting
Mainz, Germany, 55131
Contact: Tommaso Gori, MD    06131-17 ext 6903    tommaso.gori@unimedizin-mainz.de   
Principal Investigator: Tommaso Gori, MD         
Principal Investigator: Torsten Konrad, MD         
Universitätsklinikum Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Martin Borggrefe, MD    0621 383 ext 1493    martin.borggrefe@umm.de   
Principal Investigator: Jürgen Kuschyk, MD         
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen Recruiting
München, Germany, 80636
Contact: Adnan Kastrati, MD    +49 89 1218 ext 4578    kastrati@dhm.mhn.de   
Principal Investigator: Michael Joner, MD         
Klinikum Neuperlach, Städtisches Klinikum München GmbH Recruiting
München, Germany, 81737
Contact: Harald Mudra, MD    089 6794 ext 2351    kardiologie.kn@klinikum-muenchen.de   
Principal Investigator: Harald Mudra, PI         
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Contact: Lars Eckardt, MD    0251 83 ext 45160    lars.eckardt@ukmuenster.de   
Principal Investigator: Lars Eckardt, MD         
Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Klinikum Nürnberg Recruiting
Nürnberg, Germany, 90471
Contact: Matthias Pauschinger, MD       matthias.pauschinger@klinikum-nuernberg.de   
Principal Investigator: Matthias Pauschinger, MD         
Kliniken Nordoberpfalz AG, Klinikum Weiden Recruiting
Weiden, Germany, 92637
Contact: Robert Schwinger, MD    0961 303 ext 3307    robert.schwinger@kliniken-nordoberpfalz.ag   
Principal Investigator: Robert Schwinger, MD         
St. Josefs-Hospital Wiesbaden Recruiting
Wiesbaden, Germany, 65189
Contact: Joachim Ehrlich, MD    0611 177 ext 1201    jehrlich@joho.de   
Principal Investigator: Joachim Ehrlich, MD         
Sponsors and Collaborators
Klinikum der Universitaet Muenchen
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Medtronic Bakken Research Center
Investigators
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Principal Investigator: Axel Bauer, MD Klinikum der Universitaet Muenchen
Principal Investigator: Stefan Kaeaeb, MD Klinikum der Universitaet Muenchen
Study Chair: Steffen Massberg, MD Klinikum der Universitaet Muenchen

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Axel Bauer, Prof. Dr. med. Axel Bauer, Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier: NCT02594488     History of Changes
Other Study ID Numbers: 118-15
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Axel Bauer, Klinikum der Universitaet Muenchen:
Myocardial infarction
Autonomic nervous system
Risk stratification
Implantable cardiac monitor
Sudden cardiac death
ECG
Additional relevant MeSH terms:
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Autonomic Nervous System Diseases
Primary Dysautonomias
Myocardial Infarction
Infarction
Nervous System Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases