Actively Recruiting

Phase Not Applicable
All Genders
NCT06188689

Evaluation of A Clinical Diagnostic Test for CRDS

Led by Population Health Research Institute · Updated on 2026-05-05

400

Participants Needed

18

Research Sites

264 weeks

Total Duration

On this page

Sponsors

P

Population Health Research Institute

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of A Clinical Diagnostic Test for CRDS

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of an RyR2 variant confirmed to be loss-of-function on in vitro testing
  • Clinical phenotype consistent with Expert Consensus Statement for CPVT
  • Presence of a confirmed or presumed pathogenic gain-of-function RyR2 variant or homozygous/compound heterozygous for likely pathogenic/pathogenic CASQ2 variants
  • Cardiac arrest requiring cardioversion or defibrillation unexplained by ECG, echocardiogram, coronary assessment, cardiac MRI, and exercise treadmill test
  • Undergoing genetic testing that includes screening of RyR2
  • Undergoing an invasive electrophysiology study
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Use of QT prolonging medication (except flecainide) at the time of burst pacing maneuvers
  • Ventricular cardiomyopathy
  • Ventricular pre-excitation
  • Long QT syndrome
  • Use of Class I or Class III anti-arrhythmic drugs at the time of the EP study
  • Known obstructive coronary artery disease (coronary stenosis >50%)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 18 locations

1

University of California

San Francisco, California, United States, 94143

Actively Recruiting

2

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

3

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

4

Antwerp University Hospital

Edegem, Antwerp, Belgium, 2650

Actively Recruiting

5

Universitair Ziekenhuis Brussel

Brussels, Belgium, 1090

Actively Recruiting

6

University of Calgary

Calgary, Alberta, Canada, T2N 1N4

Actively Recruiting

7

Children's & Women's Health Centre of British Columbia

Vancouver, British Columbia, Canada, V6H 3N1

Actively Recruiting

8

The University of British Columbia

Vancouver, British Columbia, Canada, V6T 1Z3

Actively Recruiting

9

Hamilton General Hospital

Hamilton, Ontario, Canada, L8L 2X2

Actively Recruiting

10

London Health Sciences Centre - University Hospital

London, Ontario, Canada, N6A 5A5

Actively Recruiting

11

Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7

Actively Recruiting

12

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

13

Montréal Heart Institute

Montreal, Quebec, Canada, H1T 1C8

Actively Recruiting

14

Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

15

Aarhus University Hospital

Aarhus, Denmark, DK-8200 N

Actively Recruiting

16

CHU de Bordeaux

Bordeaux, New Aquitaine, France, 33404

Actively Recruiting

17

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Actively Recruiting

18

Oxford University Hospitals

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Actively Recruiting

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Research Team

J

Jason Roberts, MD MAS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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