NCT03275584 Safety of PET MPI Using the CRCHUM N-13 Ammonia
| NCT ID | NCT03275584 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | N-13 Ammonia Safety |
| Study Type | INTERVENTIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2018-01-30 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20,000 participants in total. It began in 2018-01-30 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Positron emission tomography (PET) myocardial perfusion imaging (MPI) is an examination that helps to assess the function and perfusion of the heart. Completion of this examination requires the injection of a small dose of a radiotracer (a radioactive substance). PET MPI is a state-of-the-art non-invasive cardiac imaging tool. The main goal of the PET MPI examination is to assess if one or more of the arteries feeding blood to your heart are blocked. This examination replaces an older technology (single photon emission computed tomography, or SPECT), and allows the obtention of more accurate information, and new information that the older SPECT technology did not assess. The radiation dose received as part of the procedure is also smaller with PET versus SPECT. One of the substances which can be used for PET MPI is called N-13 ammoniac (NH3). For this clinical study, NH3 which will be produced at the Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), per the standards and methods prescribed by Health Canada. NH3 is not currently approved for clinical use by Health Canada. It is thus considered and experimental substance in the context of this study. Participants will undergo PET MPI with the CRCHUM NH3. The PET MPI procedure itself is not an experimental procedure and is not part of the research protocol. Only the use of NH3 produced at the CRCHUM is experimental. The main objective of this research study is to validate the production process and assess the safety of the NH3 produced at the CRCHUM cyclotron. Secondary objectives include the assessment of prescription practices amongst physicians who refer patients for PET MPI, and how they will change over time.
Eligibility 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)
Contact & Investigator
Daniel Juneau, MD
PRINCIPAL INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT03275584 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying N-13 Ammonia Safety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03275584 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03275584 currently recruiting?
Yes, NCT03275584 is actively recruiting participants. Contact the research team at daniel.juneau@umontreal.ca for enrollment information.
Where is the NCT03275584 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT03275584 clinical trial?
NCT03275584 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Daniel Juneau, MD at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 20,000 participants.