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NCT02560844 Clinical Trial

Cardiomyopathy Arrhythmia Risk Evaluation

Cardiomyopathy Clinical Trial

— CARE  

Official title:
Cardiomyopathy Arrhythmia Risk Evaluation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02560844
Other study ID # 08-0638
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2015
Est. completion date June 2019

Study information
Verified date October 2017
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 164
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- cardiomyopathy, primary prevention ICD

Exclusion Criteria:

- brady-pacing requirement

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada University Health Network Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks Proportion is from 0 (no patients with shocks) to 100% (all patients receive shocks) 2 years
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