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

Not yet recruiting

• Conditions: Coronary Artery Disease (CAD)

• Registration Number: NCT06822894
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Study Start: 2025-02-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 495

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE) at 1 year	1 year after the procedure	The primary outcome is MACE at 1 year, including cardiac death, any myocardial infarction and any ischaemia-driven revascularization.

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE) at 6 months	6 months after the procedure	MACE is defined as cardiac death, any myocardial infarction and any ischaemia-driven revascularization.
Major adverse cardiac events (MACE) at 1 month	1 month after the procedure	MACE is defined as cardiac death, any myocardial infarction and any ischaemia-driven revascularization.

Trial Locations

Locations (1)

Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China