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CompletedNCT02560844CAREUpdated Oct 2, 2019

Cardiomyopathy Arrhythmia Risk Evaluation

An observational study in Cardiomyopathy, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2019-10-02.

Sponsored by University Health Network, Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
164
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Cardiomyopathy

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In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 164 is close to the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with cardiomyopathy and primary prevention ICDs

Inclusion criteria

  • cardiomyopathy, primary prevention ICD

Exclusion criteria

Exclusion Criteria:

  • brady-pacing requirement
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
164 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks

    Proportion is from 0 (no patients with shocks) to 100% (all patients receive shocks)

    Time frame: 2 years

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Study locations

1 site
  • University Health Network
    Toronto, Ontario M5G 2C4, Canada
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References and documents

Publications

  • 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. PubMed 34854315 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02560844
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Sep 25, 2015
Start date
Jul 2015
Primary completion
Jun 2019
Completion
Jun 2019
Last update
Oct 2, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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