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

NCT ID: NCT02492243

Last Updated: 2015-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

PCI

Intervention Type DEVICE

ILR implantation

Intervention Type DEVICE

Interventions

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PCI

Intervention Type DEVICE

ILR implantation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role collaborator

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type DERIVED
PMID: 28069838 (View on PubMed)

Other Identifiers

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A V1CAMI 2010

Identifier Type: -

Identifier Source: org_study_id

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