NCT02594488

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

May 6, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

4.7 years

First QC Date

October 31, 2015

Last Update Submit

June 17, 2021

Conditions

Myocardial InfarctionAutonomic Nervous System Diseases

Keywords

Myocardial infarctionAutonomic nervous systemRisk stratificationImplantable cardiac monitorSudden cardiac deathECG

Outcome Measures

Primary Outcomes (1)

  • Detection of serious arrhythmic events

    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

    18 months

Secondary Outcomes (9)

  • Composite of all-cause mortality, stroke, systemic arterial thromboembolism and unplanned hospitalizations for decompensated heart failure

    18 months

  • All cause mortality

    18 months

  • Cardiovascular mortality

    18 months

  • Unplanned hospitalizations for decompensated heart failure

    18 months

  • Sinus arrest >6sec

    18 months

  • +4 more secondary outcomes

Study Arms (2)

Remote monitoring

ACTIVE COMPARATOR

Remote cardiac monitoring by the Reveal® LINQ implantable cardiac monitor

Device: Medtronic Reveal LINQ implantable cardiac monitor

Control arm

NO INTERVENTION

Follow-up at the same frequency, but with no implantable cardiac monitor

Interventions

Medtronic Reveal LINQ implantable cardiac monitorDEVICE

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.

Remote monitoring

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III

Innsbruck, 6020, Austria

Location

Städtisches Klinikum Karlsruhe, Medizinische Klinik IV

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Universitätsklinikum Tübingen, Medizinische Klinik III

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinikum der Universität München

Munich, Bavaria, 81377, Germany

Location

Technische Universität München, Medizinische Klinik und Poliklinik I

München, Bavaria, 81675, Germany

Location

Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II

Regensburg, Bavaria, 93053, Germany

Location

HELIOS Herzzentrum Wuppertal, Klinik für Kardiologie

Wuppertal, North Rhine-Westphalia, 42117, Germany

Location

Universitätsklinikum des Saarlandes, Medizinische Klinik III

Homburg, Saarland, 66421, Germany

Location

Universtitätsklinikum der RWTH Aachen, Medizinische Klinik I

Aachen, 52074, Germany

Location

Universitätsmedizin Berlin, Klinik für Kardiologie, Charite, Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Universitätsmedizin Berlin, Klinik für Kardiologie, Charite, Campus Virchow Kinikum

Berlin, 13353, Germany

Location

Klinik Höhenried, Rehabilitationszentrum am Starnberger See

Bernried, 82347, Germany

Location

Herzzentrum Dresden, Univeristätsklinik an der TU Dresden

Dresden, 01307, Germany

Location

Universitätklinikum Essen, Klinik für Kardiologie und Angiologie

Essen, 45122, Germany

Location

Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen

Füssen, 87629, Germany

Location

Universitätsmedizin Göttingen, Klinikum für Kardiologie und Pneumologie

Göttingen, Germany

Location

Universitätsmedizin Greifswald, Klinik für Innere Medizin B

Greifswald, 17475, Germany

Location

Asklepios Klinik St. Georg, Abteilung für Kardiologie

Hamburg, 20099, Germany

Location

Universitäres Herzzentrum Hamburg GmbH

Hamburg, 20251, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III

Kiel, 24105, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Leipzig Heart Institute GmbH

Leipzig, 04289, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik II

Lübeck, 23538, Germany

Location

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

München, 80636, Germany

Location

Klinikum Neuperlach, Städtisches Klinikum München GmbH

München, 81737, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Klinikum Nürnberg

Nuremberg, 90471, Germany

Location

Kliniken Nordoberpfalz AG, Klinikum Weiden

Weiden, 92637, Germany

Location

St. Josefs-Hospital Wiesbaden

Wiesbaden, 65189, Germany

Location

Related Publications (5)

  • Rizas KD, Nieminen T, Barthel P, Zurn CS, Kahonen M, Viik J, Lehtimaki T, Nikus K, Eick C, Greiner TO, Wendel HP, Seizer P, Schreieck J, Gawaz M, Schmidt G, Bauer A. Sympathetic activity-associated periodic repolarization dynamics predict mortality following myocardial infarction. J Clin Invest. 2014 Apr;124(4):1770-80. doi: 10.1172/JCI70085. Epub 2014 Mar 18.

    PMID: 24642467BACKGROUND

  • Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.

    PMID: 16714188BACKGROUND

  • Bauer A, Sappler N, von Stulpnagel L, Klemm M, Schreinlechner M, Wenner F, Schier J, Al Tawil A, Dolejsi T, Krasniqi A, Eiffener E, Bongarth C, Stuhlinger M, Huemer M, Gori T, Wakili R, Sahin R, Schwinger R, Lutz M, Luik A, Gessler N, Clemmensen P, Linke A, Maier LS, Hinterseer M, Busch MC, Blaschke F, Sack S, Lennerz C, Licka M, Tilz RR, Ukena C, Ehrlich JR, Zabel M, Schmidt G, Mansmann U, Kaab S, Rizas KD, Massberg S; SMART-MI-DZHK9 investigators. 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. Lancet Digit Health. 2022 Feb;4(2):e105-e116. doi: 10.1016/S2589-7500(21)00253-3.

    PMID: 35090674DERIVED

  • Hamm W, Rizas KD, Stulpnagel LV, Vdovin N, Massberg S, Kaab S, Bauer A. 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.

    PMID: 28760211DERIVED

  • Rizas KD, Hamm W, Kaab S, Schmidt G, Bauer A. 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.

    PMID: 27403291DERIVED

Related Links

MeSH Terms

Conditions

Myocardial InfarctionAutonomic Nervous System DiseasesDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisNervous System DiseasesHeart ArrestDeath, SuddenDeath

Study Officials

  • Axel Bauer, MD

    LMU Klinikum

    PRINCIPAL INVESTIGATOR

  • Stefan Kaeaeb, MD

    LMU Klinikum

    PRINCIPAL INVESTIGATOR

  • Steffen Massberg, MD

    LMU Klinikum

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Axel Bauer

Study Record Dates

First Submitted

October 31, 2015

First Posted

November 3, 2015

Study Start

May 6, 2016

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations

DE(31)AU(1)