NCT02492243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

3.8 years

First QC Date

June 30, 2015

Last Update Submit

July 2, 2015

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (5)

  • Cardiac arrest

    24 months

  • Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias

    24 months

  • Ventricular fibrillation

    24 months

  • Atrial Fibrillation (symptomatic and asymptomatic)

    24 months

  • Documented Arrhythmic death without evidence of primary non cardiac cause

    24 months

Secondary Outcomes (5)

  • All Arrhythmic events recorded by ILR

    24 months

  • Changing in treatment strategy, based on physician decision

    24 months

  • Invasive procedures for arrhythmia treatment

    24 months

  • Changing in medical treatment (anticoagulation, antiarrhythmic drugs)

    24 months

  • CV events

    24 months

Study Arms (1)

Group 1

EXPERIMENTAL

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: PCIDevice: ILR implantation

Interventions

PCIDEVICE
Group 1
ILR implantationDEVICE
Group 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, 630055, Russia

Location

Related Publications (1)

  • 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.

    PMID: 28069838DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 8, 2015

Study Start

August 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

RU(1)