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

Last updated: September 4, 2024
Sponsor: Ionetix Corporation
Overall Status: Completed

Phase

N/A

Condition

Occlusions

Chest Pain

Cardiovascular Disease

Treatment

Myocardial Perfusion Imaging Study

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

Clinical Study ID

NCT04343209
Pro00042364
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Adults ≥18 able to give informed consent.

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

Exclusion

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

Study Design

Total Participants: 170
Treatment Group(s): 2
Primary Treatment: Myocardial Perfusion Imaging Study
Phase:
Study Start date:
September 14, 2020
Estimated Completion Date:
August 16, 2024

Study 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.

Connect with a study center

  • Doral Imaging Institute, LLC dba CIRA

    Miami, Florida 33165
    United States

    Site Not Available

  • Doral Imaging Institute, LLC DBA CIRA Miami Beach

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Adler Institute for Advanced Imaging

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Molecular Imaging Technologies

    El Paso, Texas 79912
    United States

    Site Not Available

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