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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 2

Conditions: Myocardial Infarction

Treatments: Device: PCI; Device: ILR implantation

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02492243

A V1CAMI 2010

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Group 1

Experimental group

Description:

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

Treatment:

Device: PCI

Device: ILR implantation