Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction and pREServed Left venTricle Ejection Fraction
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Ventricular fibrillation
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The trial will inform whether detection of ventricular arrhythmias by means of implantable loop recorder (ILR) can help to predict SCD in the large population of survivors of a myocardial infarction with preserved left ventricular function, EF>40%. This may improve risk stratification in these patients, and can inform on the clinical use of subcutaneous monitors to identify post-infarction populations in need for an intervention to prevent sudden death.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Ventricular fibrillation
Time Frame: 24 months
Cardiac arrest
Time Frame: 24 months
Documented Arrhythmic death without evidence of primary non cardiac cause
Time Frame: 24 months
Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias
Time Frame: 24 months
Atrial Fibrillation (symptomatic and asymptomatic)
Time Frame: 24 months
Secondary Outcomes
- Changing in treatment strategy, based on physician decision(24 months)
- CV events(24 months)
- Invasive procedures for arrhythmia treatment(24 months)
- All Arrhythmic events recorded by ILR(24 months)
- Changing in medical treatment (anticoagulation, antiarrhythmic drugs)(24 months)