NCT06822894

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 494 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, observational, single-center study. The main purpose of this study is to explore the predictive value of three coronary vessel-ultrasonic flow ratio (3V-UFR) for major adverse cardiovascular events (MACE) in patients with coronary artery disease within one year. The study will be conducted in Fuwai Hospital, and a total of at least 494 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). IVUS imaging will be sent to an independent core laboratory for offline UFR calculation. Subsequently, a one-year follow-up was conducted on the patients. The primary endpoint was MACE within one year, which included cardiac death, any myocardial infarction, and ischemia-driven coronary revascularization. The association between the 3V-UFR (low 3V-UFR and high 3V-UFR grouped by median of 3V-UFR) and MACE is investigated, to determine its role in clinical prognosis for patient with coronary artery disease.

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
OTHER	Not applicable- observational study	UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: China