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Cardiomyopathy Arrhythmia Risk Evaluation

Cardiomyopathy Arrhythmia Risk Evaluation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02560844
Acronym
CARE
Enrollment
164
Registered
2015-09-25
Start date
2015-07-31
Completion date
2019-06-30
Last updated
2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy

Brief summary

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

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.

Interventions

None listed

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* cardiomyopathy, primary prevention ICD

Exclusion criteria

* brady-pacing requirement

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks2 yearsProportion is from 0 (no patients with shocks) to 100% (all patients receive shocks)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026