Testing Pacing for calcium release deficiency syndrome (CRDS)
Official title: Evaluation of A Clinical Diagnostic Test for CRDS
Evaluation of a Clinical Diagnostic Test for Calcium Release Deficiency Syndrome: The DIAGNOSE CRDS Study
- 1 group
- Sites in Calgary, Edmonton and 7 more cities
- Recruiting
Interventions
- Other intervention
Pacing
1. Ventricular 10 beat burst at 500ms (120bpm) 2. Ventricular 10 beat burst at 400ms (150bpm) 3. Atrial 10 beat burst at 500ms (120bpm) 4. Atrial 10 beat burst at 400ms (150bpm).
Canadian Sites (10)
10 of 10 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
- Recruiting
Alberta Health Services
Edmonton, Alberta
- Recruiting
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia
- Recruiting
The University of British Columbia
Vancouver, British Columbia
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
- Recruiting
London Health Sciences Centre - University Hospital
London, Ontario
- Recruiting
Ottawa Heart Institute
Ottawa, Ontario
- Recruiting
Toronto General Hospital
Toronto, Ontario
- Recruiting
Montréal Heart Institute
Montreal, Quebec
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval
Québec, Quebec
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Presence of an RyR2 variant confirmed to be loss-of-function on in vitro testing
Exclusion
- −Unable to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −CohortCohortA group of participants sharing a characteristic, followed together.Read more → 2: Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Cases
- −Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- −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
- −Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −Unable to provide informed consent
- −Use of a QT prolonging medication, aside from flecainide, at the time of the burst pacing maneuvers
- −Cohort 3: Survivors of Unexplained Cardiac Arrest (UCA)
- −Inclusion criteria:
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → of RyR2\*
- −Exclusion criteria:
- −Unable to provide informed consent
- −Use of a QT prolonging medication at the time of the burst pacing maneuvers
- −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).
- −Cohort 4: SVT controlsControl groupThe group a new treatment is measured against.Read more →
- −Inclusion criteria:
- −Undergoing an invasive electrophysiology study
- −Exclusion criteria:
- −Ventricular cardiomyopathy
- −Ventricular pre-excitation
- −Long QT syndrome
- −Use of a QT prolonging medication at the time of the EP study
- −Use of a Class I or Class III anti-arrhythmic drug at the time of the EP study
- −Known obstructive coronary artery disease (existing coronary stenosis \>50%)
- −Unable to provide informed consent
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to identify or measure a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Pacing.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 400 people.
The study is currently expected to finish around March 2028.
The main measurement is taken over: At time of pacing maneuver.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
ΔT-wave amplitude value — measured over At time of pacing maneuver.
ΔQT value — measured over At time of pacing maneuver.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06188689 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PacingDiagnostic test
1. Ventricular 10 beat burst at 500ms (120bpm) 2. Ventricular 10 beat burst at 400ms (150bpm) 3. Atrial 10 beat burst at 500ms (120bpm) 4. Atrial 10 beat burst at 400ms (150bpm).
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At time of pacing maneuver.
The study as a whole is currently expected to finish around 2028-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 400 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 11 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada, and 5 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (2)
Mayo Clinic
Rochester, Minnesota, United States
University of Washington
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.