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

Phase 2

Completed

• Conditions: Myocardial Infarction
• Interventions: Device: PCI; Device: ILR implantation

• Registration Number: NCT02492243
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-06-30
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-02
• Last Update Submitted: 2015-07-02
• Study First Posted: 2015-07-08
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	ILR implantation	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
Group 1	PCI	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

Primary Outcome Measures

Name	Time	Method
Ventricular fibrillation	24 months
Cardiac arrest	24 months
Documented Arrhythmic death without evidence of primary non cardiac cause	24 months
Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias	24 months
Atrial Fibrillation (symptomatic and asymptomatic)	24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation; 🇷🇺 Novosibirsk, Russian Federation