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OpenTrials
Completed

NCT Number: NCT02560844

Cardiomyopathy Arrhythmia Risk Evaluation

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

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Key information

Conditions

Cardiomyopathy Cardiomyopathies Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cardiomyopathy, primary prevention ICD

Exclusion criteria

  • brady-pacing requirement

Treatment and study plan

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: CARE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2015
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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