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CARE: Cardiomyopathy Arrhythmia Risk Evaluation

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT02560844
Collaborator
(none)
164
Enrollment
1
Location
47
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the prognostic utility of novel ECG markers of electrical instability in patients with cardiomyopathy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Baseline ECG markers of electrical instability will be measured in patients with cardiomyopathy. These ECG markers will be evaluated from a clinical Holter recording. All patients will have a primary implantable cardioverter defibrillator (ICD) as part of their clinical care. Patients will be followed prospectively for 2 years to evaluate the primary outcome of appropriate ICD shocks. Multivariable modelling will be performed to determine whether the ECG markers of electrical instability independently predict the primary clinical outcome.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    164 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cardiomyopathy Arrhythmia Risk Evaluation
    Study Start Date :
    Jul 1, 2015
    Actual Primary Completion Date :
    Jun 1, 2019
    Actual Study Completion Date :
    Jun 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks [2 years]

      Proportion is from 0 (no patients with shocks) to 100% (all patients receive shocks)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • cardiomyopathy, primary prevention ICD
    Exclusion Criteria:
    • brady-pacing requirement

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network Toronto Ontario Canada M5G 2C4

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT02560844
    Other Study ID Numbers:
    • 08-0638
    First Posted:
    Sep 25, 2015
    Last Update Posted:
    Oct 2, 2019
    Last Verified:
    Oct 1, 2017
    Additional relevant MeSH terms:
    Cardiomyopathies

    Study Results

    No Results Posted as of Oct 2, 2019