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

Ionetix

Status: Completed

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

Treatments: Drug: AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]; Diagnostic Test: Myocardial Perfusion Imaging Study

Study type: Observational

Funder types: Industry

Identifiers

NCT04343209

Pro00042364

Details and patient eligibility

About

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.

Full description

This is a prospective, multicenter database that will be populated by sites utilizing N-13 Ammonia and sponsored by Ionetix. Each site with access to N-13 produced under an investigational new drug (IND) application will be eligible to participate. Once the site is activated, the site will enroll patients into the database that are scheduled for clinically indicated PET-MPI with N-13 (as determined by their treating physicians). PET-MPI perfusion, MBF, percent ischemia, pharmacologic stress agent, and gated left ventricular ejection fraction/function values will be collected when available, in an anonymous fashion and uploaded into the database. All patient health identifiers (PHI) will be removed prior to upload. No procedures additional to those clinically indicated will be performed for the purposes of this study.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adults ≥18 able to give informed consent.

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

Exclusion criteria

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

Trial design

170 participants in 1 patient group

Individuals with confirmed or suspected cardiovascular disease

Description:

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.

Treatment:

Diagnostic Test: Myocardial Perfusion Imaging Study

Drug: AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]