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FRCP",{"type":310,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[312],{"name":313,"class":314},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100530585","evaluation-of-a-clinical-diagnostic-test-for-crds-100530585",false,"NCT06188689","Evaluation of A Clinical Diagnostic Test for CRDS","Evaluation of a Clinical Diagnostic Test for Calcium Release Deficiency Syndrome: The DIAGNOSE CRDS Study","DIAGNOSE CRDS","Cohort 1: Calcium Release Deficiency Syndrome (CRDS) Cases\n\nInclusion criteria:\n\n• Presence of an RyR2 variant confirmed to be loss-of-function on in vitro testing\n\nExclusion criteria:\n\n• Unable to provide informed consent\n\nCohort 2: Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Cases\n\nInclusion criteria:\n\n* Satisfy a clinical phenotype consistent with the Expert Consensus Statement\n* Presence of a confirmed or presumed pathogenic gain-of-function RyR2 variant OR homozygous or compound heterozygous for likely pathogenic\u002Fpathogenic CASQ2 variants\n\nExclusion criteria:\n\n* Unable to provide informed consent\n* Use of a QT prolonging medication, aside from flecainide, at the time of the burst pacing maneuvers\n\nCohort 3: Survivors of Unexplained Cardiac Arrest (UCA)\n\nInclusion criteria:\n\n* Cardiac arrest requiring cardioversion or defibrillation that remains unexplained following an ECG, echocardiogram, coronary assessment, cardiac MRI, and exercise treadmill test\n* Undergone genetic testing that includes screening of RyR2\\*\n\nExclusion criteria:\n\n* Unable to provide informed consent\n* Use of a QT prolonging medication at the time of the burst pacing maneuvers\n\n  * Among survivors of UCA that possess a rare RyR2 variant in the absence of a CPVT phenotype, in vitro functional testing will be performed in order to confirm it is not loss- or gain-of-function (and will be arranged through the laboratory of Dr. Wayne Chen at the University of Calgary).\n\nCohort 4: SVT controls\n\nInclusion criteria:\n\n• Undergoing an invasive electrophysiology study\n\nExclusion criteria:\n\n* Ventricular cardiomyopathy\n* Ventricular pre-excitation\n* Long QT syndrome\n* Use of a QT prolonging medication at the time of the EP study\n* Use of a Class I or Class III anti-arrhythmic drug at the time of the EP study\n* Known obstructive coronary artery disease (existing coronary stenosis \\>50%)\n* Unable to provide informed consent","ALL",{"count":325,"type":326},400,"ESTIMATED","INTERVENTIONAL",[329],"NA","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.",[332],"Calcium Release Deficiency Syndrome (CRDS)",[334],"cardiac arrhythmia, sudden cardiac death, cardiac ryanodine receptor, unexplained cardiac arrest","2026-05-28",{"date":337,"type":338},"2026-06-01","ACTUAL",{"date":340,"type":338},"2023-02-02",{"date":342,"type":326},"2028-03",{"name":5,"class":6},19]