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OpenTrials
Completed

NCT Number: NCT02492243

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCI

Device

ILR implantation

Device

Primary outcomes

  1. Cardiac arrest

    Time frame: 24 months

  2. Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias

    Time frame: 24 months

  3. Ventricular fibrillation

    Time frame: 24 months

  4. Atrial Fibrillation (symptomatic and asymptomatic)

    Time frame: 24 months

  5. Documented Arrhythmic death without evidence of primary non cardiac cause

    Time frame: 24 months

Secondary outcomes

  1. All Arrhythmic events recorded by ILR

    Time frame: 24 months

  2. Changing in treatment strategy, based on physician decision

    Time frame: 24 months

  3. Invasive procedures for arrhythmia treatment

    Time frame: 24 months

  4. Changing in medical treatment (anticoagulation, antiarrhythmic drugs)

    Time frame: 24 months

  5. CV events

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2015
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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