The RAPID-WATER-FLOW Trial is a Phase III clinical research trial which uses new investigational technology in conjunction with PET imaging to visualize and quantify blood flow in the heart muscle. The trial is sponsored by MedTrace Pharma.
The RAPID-WATER-FLOW Trial is a Phase III clinical research trial which uses new investigational technology in conjunction with PET imaging to visualize and quantify blood flow in the heart muscle. The trial is sponsored by MedTrace Pharma.
The RAPID-WATER-FLOW Trial is a Phase III clinical trial to determine the efficacy of radiolabeled water to detect region(s) of narrowed or clogged blood vessels to diagnose coronary artery disease (CAD).
Radiolabeled water moves through the blood like regular water while creating signals that can be picked up by a PET (Positron Emission Tomography) camera. Regions in the heart where the water does not easily reach indicate that blood may not be flowing properly.
Participation in this study WILL NOT alter your medical treatment plan.
If you are eligible to participate, the study doctor will provide you with additional information about what to expect during and after the procedure. You will also review and sign a consent form that outlines the potential risks and benefits of study participation.
Participation in the trial will be 30 days or less. Participants will undergo a PET/CT scan that involves your heart at a resting state followed by the administration of a vasodilator (adenosine), which increases blood flow to the heart muscle.
To date, no significant side effects have been observed related to the administration of radiolabeled water. While radiolabeled water has not been approved by the Food and Drug Administration (FDA), it has been studied in humans for over 40 years.
Total radiation exposure from a single PET/CT scan in this study is less than a conventional diagnostic CT scan. The risks for serious adverse events associated with adenosine administration are low for patients who fit within the inclusion and exclusion criteria, which the study doctor will confirm. Adenosine can cause mild discomfort, such as shortness of breath and irregular heartbeat.
Contact the trial site nearest you.
North America sites contact information
200 Lothrop St Third floor, Pittsburgh, PA 15213, United States
Contact person: Chrissee Smith, RN, BSN
Clinical Research Nurse Coordinator
E-mail: smithcm37@upmc.edu
Phone: +1 (412) 647-4463
