Cardiomyopathy Arrhythmia Risk Evaluation

NCT ID: NCT02560844

Last Updated: 2019-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* cardiomyopathy, primary prevention ICD

Exclusion Criteria

* brady-pacing requirement
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Suszko AM, Chakraborty P, Viswanathan K, Barichello S, Sapp J, Talajic M, Laksman Z, Yee R, Woo A, Spears D, Adler A, Rakowski H, Chauhan VS. Automated Quantification of Abnormal QRS Peaks From High-Resolution ECGs Predicts Late Ventricular Arrhythmias in Hypertrophic Cardiomyopathy: A 5-Year Prospective Multicenter Study. J Am Heart Assoc. 2022 Dec 6;11(23):e026025. doi: 10.1161/JAHA.122.026025. Epub 2022 Nov 29.

Reference Type DERIVED
PMID: 36444865 (View on PubMed)

Chakraborty P, Suszko AM, Viswanathan K, Sheikholeslami K, Spears D, Adler A, Woo A, Rakowski H, Chauhan VS. Microvolt QRS Alternans in Hypertrophic Cardiomyopathy: A Novel Risk Marker of Late Ventricular Arrhythmias. J Am Heart Assoc. 2021 Dec 7;10(23):e022036. doi: 10.1161/JAHA.121.022036. Epub 2021 Dec 2.

Reference Type DERIVED
PMID: 34854315 (View on PubMed)

Other Identifiers

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08-0638

Identifier Type: -

Identifier Source: org_study_id

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