Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Coronary Artery Lesions

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new method called the ultrasonic flow ratio (UFR) to help doctors assess the severity of narrowing in coronary arteries, which can cause heart problems. The study will take place at Fuwai Hospital and aims to recruit 408 patients who have a certain level of blockage (between 30% and 80%) in their coronary arteries. To participate, individuals must be at least 18 years old and have stable or unstable chest pain, or have recently experienced a heart attack. Participants will need to provide written consent and will undergo a specific imaging test called intravascular ultrasound (IVUS), followed by a pressure test known as fractional flow reserve (FFR), to compare the effectiveness of UFR against the standard method.

If you qualify and decide to join, you will receive these tests that will help determine how well blood is flowing through your coronary arteries. It's important to note that some people may not be eligible, especially if they have severe heart conditions, recent heart attacks, or certain allergies. This study is still in the planning stages and has not yet started recruiting participants, but it could lead to better ways of understanding heart artery blockages in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction
• • Age ≥18 years
• • Written informed consent
• • Intermediated coronary lesions (diameter stenosis of 30%-80% by visual estimation from coronary angiography)
• Exclusion Criteria:
• • Ineligible for diagnostic IVUS or FFR examination
• • Prior coronary artery bypass grafting of the interrogated vessels
• • Myocardial infarction within 72 h of coronary angiography
• • Severe heart failure
• • Serum creatinine levels \>150 umol/L, or glomerular filtration rates \<45 ml/kg/1.73 m2
• • Allergy to the contrast agent or adenosine
• • Life expectancy \< 2 years
• • IVUS pullback not covering the entire lesion
• • Severe myocardial bridge in the interrogated vessel