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
About this trial
This is an interventional diagnostic trial for Myocardial Infarction
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
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
NCT ID
NCT02492243
First Posted
June 30, 2015
Last Updated
July 2, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Medtronic Bakken Research Center
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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