Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients with Coronary Artery Disease (FUNCTION III)

National Center for Cardiovascular Diseases

Status: Not yet enrolling

Conditions: Coronary Artery Disease (CAD)

Treatments: Diagnostic Test: fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)

Study type: Observational

Funder types: Other

Identifiers

NCT06822894

2024-2-4034

Details and patient eligibility

About

This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant three coronary stenosis with conventional pressure wire-based fractional flow reserve (FFR) as the standard reference. The study will be conducted in Fuwai Hospital, and a total of at least 495 patients with all the three coronary vessel diameter stenoses ≥30% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS) followed by FFR examination. IVUS imaging will be sent to an independent core laboratory for UFR calculation. UFR analyses were performed offline in a blinded fashion without awareness of FFR measurement. Using FFR≤0.80 as the gold standard, the sensitivity and specificity of UFR in the functional significance of all the three coronary artery stenoses will be analyzed.

Enrollment: 495 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction; Age ≥18 years; Written informed consent; Angiographically confirmed ≥30% diameter stenosis in all three major epicardial coronary arteries (left anterior descending, left circumflex, and right coronary artery); Patients with clinical indications for revascularization who have successfully completed percutaneous coronary intervention (PCI) prior to study enrollment.

Exclusion criteria

Ineligible for diagnostic IVUS examination; Prior coronary artery bypass grafting (CABG); Myocardial infarction within 72 hours 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; Severe coronary artery disease requiring CABG identified during angiography; Extreme vascular tortuosity precluding IVUS catheter advancement; Suboptimal IVUS image quality impairing quantitative analysis.