← Back to Search

Radioactive Drug

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

N/A
Waitlist Available
Led By Prem Soman, MD
Research Sponsored by Ionetix Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an estimated average of 2 hours
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Cardiovascular Disease
  • Single Ventricle Heart Disease
  • Myocardial Ischemia
  • Coronary Heart Disease
  • Chorioretinal Vascular Disease
  • Arteriosclerosis
  • Stenosis
  • Coronary Artery Disease
  • Hardening of the Arteries
  • Vascular Disease
  • Heart Disease
  • Arterial Occlusive Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an estimated average of 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and an estimated average of 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Establish the N-13 measured MBF (ml/g/min) value range

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Individuals with confirmed or suspected cardiovascular diseaseExperimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Myocardial Perfusion Imaging Study
2020
N/A
~170
AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]
2020
N/A
~170

Find a Location

Who is running the clinical trial?

Ionetix CorporationLead Sponsor
Prem Soman, MDPrincipal InvestigatorConsultant
2 Previous Clinical Trials
37 Total Patients Enrolled
Joseph OliverioStudy DirectorIonetix Corporation
~33 spots leftby Dec 2025