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CanCARD-MR: IMAGE-HF: Project IIa Canadian CArdiomyopathy Registry for Device Therapy

Sponsor
Ottawa Heart Institute Research Corporation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04908306
Collaborator
(none)
502
Enrollment
129.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Device therapy using defibrillators and cardiac resynchronization therapy (CRT) is an important advance in the care of patients with acquired heart disease and heart failure. In specific groups these devices appear to significantly reduce the risk of sudden cardiac death and progression of heart failure. However, our ability to identify ideal candidates, and those who are most likely to respond and benefit from this therapy, is poor.

    Preliminary studies using specialized Magnetic Resonance Imaging (MRI) appears to be one of the more valuable ways of predicting response to device therapy and holds substantial promise for patients with cardiomyopathy.

    Large, prospective registries are necessary to explore its real-world utility for risk prediction across a broad spectrum of patients. Can-CARD MR is a national, multi-centre registry designed to address this particular need.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    502 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    IMAGE-HF: Project IIa - Canadian CArdiomyopathy Registry for Device Therapy (CanCARD-MR)
    Actual Study Start Date :
    Oct 11, 2011
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Aug 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of a)appropriate ICD therapy (shock or anti-tachycardia pacing (ATP)) or sudden cardiac death [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • .Any patient accepted for primary prevention ICD (+/-) CRT)
    Exclusion Criteria:

    • Known contra-indications to MRI.

    • Recent myocardial infarction or revascularization procedure within the past 3 months.

    • GFR (glomerular filtration rate) ≤ 30 ml. / min/ m2.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ottawa Heart Institute Research Corporation

    Investigators

    • Principal Investigator: David Birnie, Ottawa Heart Institute Research Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ottawa Heart Institute Research Corporation
    ClinicalTrials.gov Identifier:
    NCT04908306
    Other Study ID Numbers:
    • 2011308-01
    First Posted:
    Jun 1, 2021
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiomyopathies

    Study Results

    No Results Posted as of Apr 27, 2022