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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
PCI
ILR implantation
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group 1

Arm Description

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

Outcomes

Primary Outcome Measures

Cardiac arrest
Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias
Ventricular fibrillation
Atrial Fibrillation (symptomatic and asymptomatic)
Documented Arrhythmic death without evidence of primary non cardiac cause

Secondary Outcome Measures

All Arrhythmic events recorded by ILR
Changing in treatment strategy, based on physician decision
Invasive procedures for arrhythmia treatment
Changing in medical treatment (anticoagulation, antiarrhythmic drugs)
CV events

Full Information

First Posted
June 30, 2015
Last Updated
July 2, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Medtronic Bakken Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02492243
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
PCI
Intervention Type
Device
Intervention Name(s)
ILR implantation
Primary Outcome Measure Information:
Title
Cardiac arrest
Time Frame
24 months
Title
Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias
Time Frame
24 months
Title
Ventricular fibrillation
Time Frame
24 months
Title
Atrial Fibrillation (symptomatic and asymptomatic)
Time Frame
24 months
Title
Documented Arrhythmic death without evidence of primary non cardiac cause
Time Frame
24 months
Secondary Outcome Measure Information:
Title
All Arrhythmic events recorded by ILR
Time Frame
24 months
Title
Changing in treatment strategy, based on physician decision
Time Frame
24 months
Title
Invasive procedures for arrhythmia treatment
Time Frame
24 months
Title
Changing in medical treatment (anticoagulation, antiarrhythmic drugs)
Time Frame
24 months
Title
CV events
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
28069838
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. Erratum In: Europace. 2017 May 1;19(5):811.
Results Reference
derived

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

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