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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 : Recruiting
First Posted : November 3, 2015
Last Update Posted : June 11, 2020
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 : February 2021
Estimated Study Completion Date : July 2021

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



Information from the National Library of Medicine

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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
Show Show 32 study locations
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    
Other Study ID Numbers: 118-15
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
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