NCT02560844

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 2, 2019

Status Verified

October 1, 2017

Enrollment Period

3.9 years

First QC Date

September 21, 2015

Last Update Submit

September 30, 2019

Conditions

Cardiomyopathy

Outcome Measures

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)

    2 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cardiomyopathy and primary prevention ICDs

You may qualify if:

  • cardiomyopathy, primary prevention ICD

You may not qualify if:

  • brady-pacing requirement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 36444865DERIVED

  • 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.

    PMID: 34854315DERIVED

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 25, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 2, 2019

Record last verified: 2017-10

Locations

CA(1)