NCT04908306

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

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

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
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

11.8 years

First QC Date

May 26, 2021

Last Update Submit

February 27, 2023

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

August 1, 2023

Study Completion

August 1, 2023

Last Updated

February 28, 2023

Record last verified: 2023-02