Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients With Known or Suspected CAD (Ammonia MAP)

Completed

Conditions studied: Myocardial Ischemia, Coronary Disease, Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

In brief

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.

Key facts

Study ID

NCT04343209

Run by

Ionetix Corporation

People needed

170

Starts

2020-09-14

Expected to finish

2024-08-16

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults ≥18 able to give informed consent.
• Clinical indication for PET-MPI as determined by the subject's treating physician

You may not qualify if…

• Any clinical contraindication for pharmacologic stress testing per ASNC/SNMMI/ACC myocardial perfusion imaging guidelines when stress perfusion imaging is required clinically.
• Inability or unwilling to give informed consent
• Pregnant subjects

Where it is running

• Doral Imaging Institute, LLC dba CIRA — Miami, Florida, United States
• Doral Imaging Institute, LLC DBA CIRA Miami Beach — Miami Beach, Florida, United States
• Adler Institute for Advanced Imaging — Jenkintown, Pennsylvania, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Molecular Imaging Technologies — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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