NCT04343209Completed
Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients With Known or Suspected CAD (Ammonia MAP)
Ammonia N-13 Myocardial Blood Flow Absolute Quantification by Positron Emission Tomography in Patients With Known or Suspected Coronary Artery Disease (Ammonia MAP)
Source: ClinicalTrials.gov · Last updated 5 Sept 2024
Brief summary (registry, in English)
This study is being conducted to provide access to and collect test data for an established nuclear medicine diagnostic imaging test called Positron Emission Tomography (PET), using a specific radioactive drug called Ammonia N-13 (Ammonia), referred to simply as an Ammonia PET scan, which is used to visualize the blood flow through the blood vessels and into the heart muscle in order to identify areas of restricted blood flow within the heart. The scanner used in this study may be a stand-alone PET scanner or a PET/CT scanner, which combines the PET scanner and a Computed Tomography (CT) scanner into a single device. Unless otherwise stated in this consent form, the term PET will be used to refer to both stand-alone PET and PET/CT scanners. While physicians have used the Ammonia PET test for many years to visualize (image) the blood flow into the heart muscle (perfusion), it is now possible to also measure the flow of blood into the heart muscle. Research studies have demonstrated clinical value in reviewing the measured blood flow values in addition to reviewing the perfusion images of blood flow into the heart muscle. Therefore, this study will establish a database of a large number of Ammonia PET measured blood flow values to serve as a future reference.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 170 (actual)
- First submitted
- 7 Apr 2020
- Start date
- 14 Sept 2020
- Primary completion date
- 16 Aug 2024
- Lead sponsor
- Ionetix Corporation
- Diseases
- Coronary artery disease
- NCT number
- NCT04343209
What you commit to
- Study type: Observational
- Participants enrolled: 170
- From 14 Sept 2020 to the primary completion date, 16 Aug 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any clinical contraindication for pharmacologic stress testing per ASNC/SNMMI/ACC myocardial perfusion imaging guidelines when stress perfusion imaging is required clinically.
Other
- Inability or unwilling to give informed consent
- Pregnant subjects
Who the study is looking for
- Adults ≥18 able to give informed consent.
- Clinical indication for PET-MPI as determined by the subject's treating physician
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Molecular Imaging Technologies Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Adler Institute for Advanced Imaging Coordinator of this site? Confirm its status | Jenkintown | United States | Unknown status |
| Doral Imaging Institute, LLC dba CIRA Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Doral Imaging Institute, LLC DBA CIRA Miami Beach Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.