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Evaluation of a Clinical Diagnostic Test for Calcium Release Deficiency Syndrome: The DIAGNOSE CRDS Study

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Calcium Release Deficiency Syndrome (CRDS) is a novel inherited arrhythmia syndrome secondary to RyR2 loss-of-function that confers a risk of sudden cardiac death. Diagnosis of CRDS presently requires cellular-based in vitro confirmation that an RyR2 variant causes loss-of-function. We hypothesize that CRDS can be diagnosed clinically through evaluation of the repolarization response to brief tachycardia, mediated by cardiac pacing, and a subsequent pause.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ • Presence of an RyR2 variant confirmed to be loss-of-function on in vitro testing

• Satisfy a clinical phenotype consistent with the Expert Consensus Statement

• Presence of a confirmed or presumed pathogenic gain-of-function RyR2 variant OR homozygous or compound heterozygous for likely pathogenic/pathogenic CASQ2 variants

• Cardiac arrest requiring cardioversion or defibrillation that remains unexplained following an ECG, echocardiogram, coronary assessment, cardiac MRI, and exercise treadmill test

• Undergone genetic testing that includes screening of RyR2\*

⁃ • Undergoing an invasive electrophysiology study

Locations
United States
California
University of California
RECRUITING
San Francisco
Minnesota
Mayo Clinic
RECRUITING
Rochester
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Belgium
Universitair Ziekenhuis Brussel
RECRUITING
Brussels
Antwerp University Hospital
RECRUITING
Edegem
Canada
University of Calgary
RECRUITING
Calgary
Alberta Health Services
RECRUITING
Edmonton
Hamilton General Hospital
RECRUITING
Hamilton
London Health Sciences Centre - University Hospital
RECRUITING
London
Montréal Heart Institute
RECRUITING
Montreal
Ottawa Heart Institute
RECRUITING
Ottawa
Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval
RECRUITING
Québec
Toronto General Hospital
RECRUITING
Toronto
Children's & Women's Health Centre of British Columbia
RECRUITING
Vancouver
The University of British Columbia
RECRUITING
Vancouver
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
France
CHU de Bordeaux
RECRUITING
Bordeaux
Israel
Shaare Zedek Medical Center
RECRUITING
Jerusalem
United Kingdom
Oxford University Hospitals
RECRUITING
Oxford
Contact Information
Primary
Jason Roberts, MD MAS
jason.roberts@phri.ca
905-297-3479
Time Frame
Start Date: 2023-02-02
Estimated Completion Date: 2028-03
Participants
Target number of participants: 400
Treatments
Experimental: Pacing
Separate ventricular and atrial pacing trains will be administered at different cycle lengths and the ventricular repolarization response on the first sinus beat following the subsequent pause will be evaluated.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: Population Health Research Institute

This content was sourced from clinicaltrials.gov