NCT03345615

Brief Summary

After a myocardial infarction (MI), patients discharged home in sinus rhythm may develop AF that is asymptomatic, undetected, and undertreated. Previous studies (CARISMA and ARREST) have demonstrate high rates of new-onset AF recorded on implantable loop recorder (ILR), although the routine implantation of ILRs post-MI remains costly and invasive. The external loop recorder may effectively identify patients with new-onset AF through a validated diagnostic algorithm and targeted monitoring during a high-risk period (immediately after hospital discharge). We will prospectively randomize patients to receive an external loop recorder or standard care, evaluating rates of new-onset AF developing within 30 days after MI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

4.3 years

First QC Date

November 14, 2017

Last Update Submit

August 14, 2022

Conditions

Atrial Fibrillation New OnsetMyocardial Infarction

Keywords

atrial fibrillationmyocardial infarctionintensive monitoringoral anticoagulationhospitalization

Outcome Measures

Primary Outcomes (1)

  • Incidence of new-onset AF at 30-days post-MI

    New-onset AF detected through intensive monitoring or standard care (routine assessment)

    30 days

Secondary Outcomes (3)

  • Rate of oral anticoagulation

    90 days and 1-year

  • AF-related hospitalization

    90 days and 1-year

  • Composite cardiovascular and hospitalization events

    90 days and 1-year

Study Arms (2)

Intensive Monitoring

EXPERIMENTAL

30-day ambulatory cardiac event monitoir

Diagnostic Test: 30-day ambulatory cardiac event monitor

Standard Care

NO INTERVENTION

Standard Care (no supplemental monitoring)

Interventions

30-day ambulatory cardiac event monitorDIAGNOSTIC_TEST

SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge.

Intensive Monitoring

Eligibility Criteria

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

You may qualify if:

  • Patients with ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI; Third Universal Definition of MI) with or without PCI. All patients must have troponin elevation.
  • No history of AF during hospitalization, at discharge, or pre-existing AF documented on history (i.e. hospital records, previous hospitalization, ECG records).
  • No anticoagulation for AF or other indications (i.e. LV thrombus, heart valves, venous thromboembolism/deep venous thrombosis).
  • No concomitant disease expected to reduce expected lifespan to \<2 yrs.

You may not qualify if:

  • Patients receiving CABG surgery during this hospitalization or planned cardiac surgery within the next 3 months.
  • Patients with spontaneous coronary artery dissection (SCAD), non-atherosclerotic coronary disease (NACAD), and Takotsubo cardiomyopathy are excluded from this study.
  • Patients with contraindications to anticoagulation.
  • Patients with a chronic skin disorder on the upper torso, or an allergy to medical tape or glue.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Myocardial InfarctionAtrial Fibrillation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArrhythmias, Cardiac

Study Officials

  • Jason G Andrade, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 2:1 enrollment into parallel groups (intensive monitoring vs. standard care).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

November 1, 2017

Primary Completion

March 1, 2022

Study Completion

December 1, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)