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

July 2, 2015 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
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: ILR implantation
Device: PCI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
All Arrhythmic events recorded by ILR
Time Frame: 24 months
24 months
Changing in treatment strategy, based on physician decision
Time Frame: 24 months
24 months
Invasive procedures for arrhythmia treatment
Time Frame: 24 months
24 months
Changing in medical treatment (anticoagulation, antiarrhythmic drugs)
Time Frame: 24 months
24 months
CV events
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Collaborators

Medtronic Bakken Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A V1CAMI 2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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