NCT04908306

Brief Summary

Delayed enhanced MRI in patients (of either ischemic or non-ischemic cause) being referred for primary prevention ICD

Trial Health

100
On Track

Trial Health Score

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

Enrollment
502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

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

October 11, 2011

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2024

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

12.8 years

First QC Date

May 26, 2021

Last Update Submit

May 8, 2026

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a)appropriate ICD therapy (shock or anti-tachycardia pacing (ATP)) or sudden cardiac death

    Occurrence of a)appropriate ICD therapy (shock or anti-tachycardia pacing (ATP)) or sudden cardiac death

    1 year

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for or being considered for primary prevention ICD, with or without CRT, will be recruited from the Electrophysiology services at each enrolling site

You may qualify if:

  • Any patient accepted for primary prevention ICD (+/-) CRT)

You may not qualify if:

  • Known contra-indications to MRI.
  • Recent myocardial infarction or revascularization procedure within the past 3 months.
  • GFR (glomerular filtration rate) ≤ 30 ml. / min/ m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • David Birnie

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 1, 2021

Study Start

October 11, 2011

Primary Completion

July 12, 2024

Study Completion

July 12, 2024

Last Updated

May 13, 2026

Record last verified: 2026-05