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Pacing for Hypocalcemia (DIAGNOSE CRDS Trial)

N/A

Recruiting

Led By Jason D Roberts, MD MAS

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of pacing maneuver

Awards & highlights

DIAGNOSE CRDS Trial Summary

This trial aims to find a new way to diagnose a condition called Calcium Release Deficiency Syndrome (CRDS). CRDS is a rare genetic condition that increases the risk of sudden cardiac death. Currently,

Who is the study for?

This trial is for individuals suspected to have Calcium Release Deficiency Syndrome (CRDS), a genetic heart rhythm disorder that can lead to sudden cardiac death. Participants should be able to undergo a diagnostic test involving brief, controlled increases in heart rate.Check my eligibility

What is being tested?

The study aims to evaluate if CRDS can be diagnosed without cellular tests by observing the heart's electrical recovery after it is briefly sped up using a method called pacing. This could simplify and speed up diagnosis.See study design

What are the potential side effects?

Pacing involves temporarily increasing the heart rate, which may cause discomfort, dizziness, or palpitations during the procedure. However, these effects are typically short-lived and resolve once normal rhythm is restored.

DIAGNOSE CRDS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a genetic mutation in RyR2 or CASQ2 that affects my heart.

Select...

I had a cardiac arrest that remains unexplained even after several heart tests.

Select...

I am scheduled for a detailed heart rhythm test.

Select...

My tests show a specific genetic change that doesn't work properly.

Select...

I have been genetically tested for the RyR2 mutation.

DIAGNOSE CRDS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of pacing maneuver

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of pacing maneuver

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of pacing maneuver for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ΔQT value

ΔT-wave amplitude value

Secondary outcome measures

Absolute QT value

Absolute T-wave amplitude

DIAGNOSE CRDS Trial Design

1Treatment groups

Experimental Treatment

Group I: PacingExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pacing

2019

Completed Phase 2

~90

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

679,512 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,167 Total Patients Enrolled

Ziv Dadon, MDStudy DirectorShaare Zedek Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process currently in progress for participants of this research study?

"Indeed, as stated on clinicaltrials.gov, this trial is currently actively seeking eligible participants. The initial posting of the trial occurred on February 2nd, 2023, and it was most recently updated on December 18th, 2023."

Answered by AI

In how many distinct clinics is this experimental investigation currently being conducted?

"At present, patient enrollment for this trial is open at 16 different locations. These sites are spread across several cities including Toronto, Boston, Brussels, and numerous others. To ensure minimal travel demands, it is advised to select the site closest to your location if you decide to enroll in the study."

Answered by AI

What is the current number of patients undergoing treatment in this medical study?

"A total of 400 eligible participants are needed to enroll in this clinical trial. Patients have the option to participate at various sites, including Toronto General Hospital located in Toronto, Ontario, and Boston Children's Hospital situated in Boston, Massachusetts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of A Clinical Diagnostic Test for CRDS

2023. "Evaluation of A Clinical Diagnostic Test for CRDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06188689.

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