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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492243
• Other study ID #: A V1CAMI 2010
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2015
• Last updated: July 2, 2015
• Start date: August 2011
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• PCI

• ILR implantation

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation	Novosibirsk

Sponsors (2)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation	Medtronic Bakken Research Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac arrest		24 months	Yes
Primary	Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias		24 months	Yes
Primary	Ventricular fibrillation		24 months	Yes
Primary	Atrial Fibrillation (symptomatic and asymptomatic)		24 months	Yes
Primary	Documented Arrhythmic death without evidence of primary non cardiac cause		24 months	Yes
Secondary	All Arrhythmic events recorded by ILR		24 months	Yes
Secondary	Changing in treatment strategy, based on physician decision		24 months	Yes
Secondary	Invasive procedures for arrhythmia treatment		24 months	Yes
Secondary	Changing in medical treatment (anticoagulation, antiarrhythmic drugs)		24 months	Yes
Secondary	CV events		24 months	Yes