Status:

COMPLETED

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

Lead Sponsor:

Ionetix Corporation

Conditions:

Myocardial Ischemia

Coronary Disease

Eligibility:

All Genders

18+ years

Brief 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 radioac...

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 (I...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

September 14 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 16 2024

Estimated Enrollment :

170 Patients enrolled

Trial Details

Trial ID

NCT04343209

Start Date

September 14 2020

End Date

August 16 2024

Last Update

September 5 2024

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Doral Imaging Institute, LLC dba CIRA

Miami, Florida, United States, 33165

2

Doral Imaging Institute, LLC DBA CIRA Miami Beach

Miami Beach, Florida, United States, 33140

3

Adler Institute for Advanced Imaging

Jenkintown, Pennsylvania, United States, 19046

4

UPMC

Pittsburgh, Pennsylvania, United States, 15213