NCT04343209

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 170 (actual)
• Sponsor: Ionetix Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Myocardial Ischemia
• Coronary Disease
• Coronary Artery Disease
• Heart Diseases
• Cardiovascular Diseases
• Arteriosclerosis
• Arterial Occlusive Diseases
• Vascular Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Myocardial Perfusion Imaging Study	Evaluation of myocardial perfusion via PET imaging agent
DRUG	AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]	Cardiac PET imaging agent

Timeline

• Start date: 2020-09-14
• Primary completion: 2024-08-16
• Completion: 2024-08-16
• First posted: 2020-04-13
• Last updated: 2024-09-05

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study