Assessing the safety of N-13 ammonia in heart imaging
Sûreté de la Perfusion Myocardique Par la Tomographie d'émission Par Positron Avec l'Ammoniaque marqué au N-13 du Centre de Recherche du Centre Hospitalier de l'Université de Montréal
This study is testing if using a new substance called N-13 ammonia in heart scans is safe for adults needing to check their heart function and blood flow.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT03275584 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety of using N-13 ammonia as a radiotracer in positron emission tomography (PET) myocardial perfusion imaging (MPI) to assess heart function and blood flow. The study involves administering a small intravenous dose of N-13 ammonia to adult patients referred for clinically indicated PET MPI at the Centre hospitalier de l'Université de Montréal. By utilizing this advanced imaging technique, the trial aims to provide more accurate assessments of potential blockages in heart arteries while minimizing radiation exposure compared to older imaging methods. The results will help determine the safety profile of N-13 ammonia in this context.
Who should consider this trial
Good fit: Ideal candidates are adult patients referred for clinically indicated PET myocardial perfusion imaging at the Centre hospitalier de l'Université de Montréal.
Not a fit: Patients who are pregnant, claustrophobic, breastfeeding without the ability to pause, or have contraindications to stress testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and accuracy of heart imaging procedures for patients.
How similar studies have performed: While the use of N-13 ammonia in PET MPI is established, this specific evaluation of its safety in a clinical setting is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient being referred for clinically indicated positron emission tomography myocardial perfusion imaging at the Centre hospitalier de l'Université de Montréal Exclusion Criteria: * Pregnant women * Claustrophobic patient unable to undergo the examination * Breastfeeding women unwilling to temporarily stop breastfeeding * Patient with contra-indication to: dipyridamole, aminophylline, dobutamine or exercise stress test (depending on the method of cardiovascular stress test chosen)
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Daniel Juneau, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Daniel Juneau, MD
- Email: daniel.juneau@umontreal.ca
- Phone: 1-514-890-8180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.