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Trial record 1 of 1 for:    NCT02594488
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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 : Completed
First Posted : November 3, 2015
Last Update Posted : June 23, 2021
Sponsor:
Collaborators:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Axel Bauer, LMU Klinikum

Tracking Information
First Submitted Date  ICMJE October 31, 2015
First Posted Date  ICMJE November 3, 2015
Last Update Posted Date June 23, 2021
Actual Study Start Date  ICMJE May 6, 2016
Actual Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2015)
  • 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
  • All cause mortality [ Time Frame: 18 months ]
    Time to death
  • Cardiovascular mortality [ Time Frame: 18 months ]
    Time to cardiovascular death
  • Unplanned hospitalizations for decompensated heart failure [ Time Frame: 18 months ]
    Time to unplanned hospitalizations for decompensated heart failure
  • Sinus arrest >6sec [ Time Frame: 18 months ]
    Time to detection of sinus arrest >6sec
  • Atrial fibrillation ≥6 min [ Time Frame: 18 months ]
    Time to detection of atrial fibrillation ≥6 min
  • Higher degree AV-block ≥ IIb [ Time Frame: 18 months ]
    Time to detection of higher degree AV-block ≥ IIb
  • Non-sustained ventricular tachycardia [ Time Frame: 18 months ]
    Time to detection of ventricular tachycardia with a cycle length ≤320ms lasting for ≥12 sec
  • Sustained ventricular tachycardia / ventricular fibrillation [ Time Frame: 18 months ]
    Time to detection of sustained ventricular tachycardia / ventricular fibrillation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implantable Cardiac Monitors in High-Risk Post-Infarction Patients With Cardiac Autonomic Dysfunction
Official Title  ICMJE Implantable Cardiac Monitors in High-risk Post-infarction Patients With Cardiac Autonomic Dysfunction and Moderately Reduced Left Ventricular Ejection Fraction
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Myocardial Infarction
  • Autonomic Nervous System Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Remote monitoring
    Remote cardiac monitoring by the Reveal® LINQ implantable cardiac monitor
    Intervention: Device: Medtronic Reveal LINQ implantable cardiac monitor
  • No Intervention: Control arm
    Follow-up at the same frequency, but with no implantable cardiac monitor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2015)
400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2021
Actual Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02594488
Other Study ID Numbers  ICMJE 118-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Axel Bauer, LMU Klinikum
Study Sponsor  ICMJE LMU Klinikum
Collaborators  ICMJE
  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
  • Medtronic Bakken Research Center
Investigators  ICMJE
Principal Investigator: Axel Bauer, MD LMU Klinikum
Principal Investigator: Stefan Kaeaeb, MD LMU Klinikum
Study Chair: Steffen Massberg, MD LMU Klinikum
PRS Account LMU Klinikum
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP