Myocardial Infarction
Conditions
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.
Interventions
DEVICEPCI
DEVICEILR implantation
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent signed * Documented myocardial infarction in the 7days prior to enrolment * Age \> 18 yrs * Left ventricular ejection fraction \>=40% as assessed by echocardiography within 7 days window after MI.
Exclusion criteria
* subject is unwilling or unable to comply with the study procedures * documented ventricular tachycardia or survived cardiac arrest outside of an acute coronary syndrome * Subject has indications for active implanted cardiac medical device (IPG, ICD, CRT). * contraindications for implantation of a ICM - Planned CABG procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Documented Arrhythmic death without evidence of primary non cardiac cause | 24 months |
| Cardiac arrest | 24 months |
| Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias | 24 months |
| Ventricular fibrillation | 24 months |
| Atrial Fibrillation (symptomatic and asymptomatic) | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| All Arrhythmic events recorded by ILR | 24 months |
| Changing in treatment strategy, based on physician decision | 24 months |
| Invasive procedures for arrhythmia treatment | 24 months |
| Changing in medical treatment (anticoagulation, antiarrhythmic drugs) | 24 months |
| CV events | 24 months |
Countries
Russia
Outcome results
None listed