Clinical trial NCT04343209: Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients With Known or Suspected CAD (Ammonia MAP)
Official title: Ammonia N-13 Myocardial Blood Flow Absolute Quantification by Positron Emission Tomography in Patients With Known or Suspected Coronary Artery Disease (Ammonia MAP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Coronary Disease
Coronary Artery Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Keywords: Ammonia N-13
Positron Emission Tomography
Myocardial Blood Flow
MBF
Myocardial Perfusion
Ammonia N 13 Injection, USP
Coronary Artery Disease
Lead sponsor: Ionetix Corporation
Sponsor class: INDUSTRY
First posted: 2020-04-13
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with confirmed or suspected cardiovascular disease

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Establish the N-13 measured MBF (ml/g/min) value range
timeFrame: an estimated average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Doral Imaging Institute, LLC DBA CIRA Miami Beach
state: Florida
city: Miami
country: United States
facility: Doral Imaging Institute, LLC dba CIRA
state: Florida
city: Jenkintown
country: United States
facility: Adler Institute for Advanced Imaging
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: El Paso
country: United States
facility: Molecular Imaging Technologies
state: Texas
Study officials:
affiliation: Ionetix Corporation
name: Joseph Oliverio
role: STUDY_DIRECTOR
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