CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 170 enrolled
Drug / intervention
AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13] +1 moredrug
Likely dose
AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04343209
NCT04343209N/ACompleted

Ammonia N-13 Myocardial Blood Flow Absolute Quantification by Positron Emission Tomography in Patients With Known or Suspected Coronary Artery Disease (Ammonia MAP)

Ionetix Corporation·observational·Posted Apr 13, 2020·Updated Sep 5, 2024

In Brief

An observational study evaluating Myocardial Perfusion Imaging Study and AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13] for Myocardial Ischemia and 7 related conditions. Completed, enrolled 170 participants across 5 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 13, 2020
Enrollment StartSep 14, 2020
Primary CompletionAug 16, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 6.2 years ago

Interventions

Myocardial Perfusion Imaging Studyother

Evaluation of myocardial perfusion via PET imaging agent

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

Cardiac PET imaging agent