DEFINE-FLOW
Research type
Research Study
Full title
Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect – Combined pressure and Doppler FLOW velocity measurements
IRAS ID
173550
Contact name
Justin Davies
Contact email
Sponsor organisation
University of Texas Medical School at Houston
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 20 days
Research summary
Patients that are suffering from chest pain or shortness of breath may have coronary artery disease. In this condition, fatty deposits form in the inside of the blood vessels that supply blood to the heart (coronary arteries). This can decrease the flow of blood and cause symptoms. A heart specialist (cardiologist) may recommended an angiogram, where detailed X-ray photographs are taken of the coronary arteries to assess for narrowing. \n\nDuring angiography, the possibility exists of detecting a narrowing of a heart artery that remains unclear by visual assessment whether or not it is the cause of the symptoms (so called intermediate stenoses). Stenoses are treated by placing a wire mesh tube (stent) to prop open the narrowed heart artery. However, not all heart artery narrowings need to be treated as they may not be the cause of the symptoms. To help doctors decide which narrowings need treatment and which can be left alone, fine wires are passed into the arteries to make pressure measurements. These measurement are the recommended treatment for patients with this condition because they have been shown to reduce the future need for repeat stents.\n\nHowever, recent studies have demonstrated that this pressure measurement alone is not able to distinguish whether or not a stenosis is causing the symptoms. In addition to pressure measurements, it is also possible to measure the blood flow inside the coronary arteries. The combined measurement of both blood flow and blood pressure in the heart arteries is thought to provide a more complete evaluation of which stenosis can be related to your symptoms. For this reason we would like to investigate a new treatment strategy that determines the severity of a narrowing based on pressure measurements in combination with blood flow measurements.
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/0100
Date of REC Opinion
25 Apr 2016
REC opinion
Further Information Favourable Opinion