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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main arm | Experimental | N-13 ammonia intravenous injection; 2 injections, 3-7 MBq/kg per injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-13 ammonia intravenous injection | Drug | Participants will receive two injections of N-13 ammonia, once at "rest" and once at "stress" before undergoing positron emission tomography myocardial perfusion imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reaction to the N-13 ammonia injection | The absence or presence of adverse reactions related to the N-13 ammonia injection, as a simple yes or no. The following tools will be used to establish the presence/absence of adverse reaction:
| 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of specific adverse reactions to N-13 ammonia injection | If any adverse reactions to the N-13 ammonia injection are reported (see Primary Outcome), the incidence of specific adverse reactions will be recorded and calculated. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Juneau, MD | Contact | 1-514-890-8180 | daniel.juneau@umontreal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Juneau, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'université de Montréal | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
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