Cardiomyopathy Arrhythmia Risk Evaluation

Completed

• Conditions: Cardiomyopathy

• Registration Number: NCT02560844
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-25
• Status Verified: 2017-10
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• cardiomyopathy, primary prevention ICD

Exclusion Criteria

• brady-pacing requirement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada