[15-O]-H2O PET Imaging for Coronary Artery Disease Diagnosis
The study aims to evaluate the accuracy of [15-O]-H2O PET scans in diagnosing coronary artery disease by comparing them to standard imaging methods in adults.
[O-15]-Water PET Myocardial Perfusion Imaging (MPI)
Arterial Occlusive Diseases+5
+ Arteriosclerosis
+ Cardiovascular Diseases
Diagnostic Study
Summary
Study start date: May 8, 2022
Actual date on which the first participant was enrolled.This clinical trial is designed to evaluate a new method for diagnosing coronary artery disease (CAD), a condition where the blood vessels that supply the heart with blood become narrowed or blocked. The study focuses on using a special imaging technique called PET imaging, which involves the injection of a substance known as \[15-O\]-H2O. This method is being tested on patients who are suspected to have CAD. The goal is to see if this new imaging technique can accurately identify CAD during both resting and stress conditions. Success in this study could lead to a more effective way to diagnose CAD, potentially improving treatment options and outcomes for patients. Participants in this study will receive two injections of \[15-O\]-H2O during a single imaging session. One injection occurs while the participant is at rest, and the other is given while the participant is under stress induced by a medication called adenosine. The study will measure how accurately the PET imaging results, using \[15-O\]-H2O, identify CAD compared to standard diagnostic methods. After the imaging session, a follow-up phone call will be made to ensure participant safety. This study will help determine the sensitivity and specificity of the new method, which refers to its ability to correctly identify those with and without the disease.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.215 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
Mayo Clinic
Rochester, United StatesWashington University
St Louis, United StatesUniversity of Pittsburgh Medical Center
Pittsburgh, United States