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Cardiomyopathy Arrhythmia Risk Evaluation (CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02560844
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : October 2, 2019
Information provided by (Responsible Party):
University Health Network, Toronto

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

Condition or disease

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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Primary Outcome Measures :
  1. Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks [ Time Frame: 2 years ]
    Proportion is from 0 (no patients with shocks) to 100% (all patients receive shocks)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cardiomyopathy and primary prevention ICDs

Inclusion Criteria:

  • cardiomyopathy, primary prevention ICD

Exclusion Criteria:

  • brady-pacing requirement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02560844

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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: University Health Network, Toronto Identifier: NCT02560844     History of Changes
Other Study ID Numbers: 08-0638
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2017
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases