Ammonia N-13 Myocardial Blood Flow Absolute Quantification by Positron Emission Tomography in Patients With Known or Suspected Coronary Artery Disease (Ammonia MAP)

Status: Completed
Location: See all (5) locations...
Intervention Type: Drug, Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults ≥18 able to give informed consent.

• Clinical indication for PET-MPI as determined by the subject's treating physician

Locations
United States
Florida
Doral Imaging Institute, LLC dba CIRA
Miami
Doral Imaging Institute, LLC DBA CIRA Miami Beach
Miami Beach
Pennsylvania
Adler Institute for Advanced Imaging
Jenkintown
UPMC
Pittsburgh
Texas
Molecular Imaging Technologies
El Paso
Time Frame
Start Date: 2020-09-14
Completion Date: 2024-08-16
Participants
Target number of participants: 170
Treatments
Individuals with confirmed or suspected cardiovascular disease
Individuals in this group will undergo myocardial perfusion imaging, utilizing Ammonia N-13 PET imaging agent. Each individual will receive two intravenous injections of Ammonia N-13 in accordance with site imaging protocol.
Related Therapeutic Areas
Sponsors
Leads: Ionetix Corporation

This content was sourced from clinicaltrials.gov