Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction andpREServed Lef venTricle Ejection Fraction (ARREST)

Study Overview
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Brief Summary
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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.

Official Title
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Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction and pREServed Left venTricle Ejection Fraction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Device: PCI
* Device: ILR implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Patients with documented myocardial infarction in the 7days prior to enrolment and left ventricular ejection fraction >=40% as assessed by echocardiography within 7 days window after MI,who are not candidate to ICD/CRT/IPG implantation after PCI undergo ILR implantation | Device: PCI<br> <br> Device: ILR implantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac arrest |  | 24 months | 
| Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias |  | 24 months | 
| Ventricular fibrillation |  | 24 months | 
| Atrial Fibrillation (symptomatic and asymptomatic) |  | 24 months | 
| Documented Arrhythmic death without evidence of primary non cardiac cause |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |