Clinical trial NCT02492243: Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction andpREServed Lef venTricle Ejection Fraction (ARREST)
Official title: Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction and pREServed Left venTricle Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
Collaborators: name: Medtronic Cardiac Rhythm and Heart Failure
First posted: 2015-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Cardiac arrest
timeFrame: 24 months
measure: Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias
timeFrame: 24 months
measure: Ventricular fibrillation
timeFrame: 24 months
measure: Atrial Fibrillation (symptomatic and asymptomatic)
timeFrame: 24 months
measure: Documented Arrhythmic death without evidence of primary non cardiac cause
timeFrame: 24 months
Secondary outcomes:
measure: All Arrhythmic events recorded by ILR
timeFrame: 24 months
measure: Changing in treatment strategy, based on physician decision
timeFrame: 24 months
measure: Invasive procedures for arrhythmia treatment
timeFrame: 24 months
measure: Changing in medical treatment (anticoagulation, antiarrhythmic drugs)
timeFrame: 24 months
measure: CV events
timeFrame: 24 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Study officials:
References:
citation: Romanov A, Martinek M, Purerfellner H, Chen S, De Melis M, Grazhdankin I, Ponomarev D, Losik D, Strelnikov A, Shabanov V, Karaskov A, Pokushalov E. Incidence of atrial fibrillation detected by continuous rhythm monitoring after acute myocardial infarction in patients with preserved left ventricular ejection fraction: results of the ARREST study. Europace. 2018 Feb 1;20(2):263-270. doi: 10.1093/europace/euw344.