NCT06052670

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 408 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center study. The primary purpose of this study is to evaluate the sensitivity and specificity of offline computational ultrasonic flow ratio (UFR) 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 408 patients with coronary vessel diameter stenosis ≥30% and ≤80% 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 coronary artery stenosis will be analyzed.

Conditions

• Coronary Artery Stenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)	pressure wire-based fractional flow reserve (FFR); intravascular ultrasound (IVUS)-based ultrasonic flow ratio (UFR)

Timeline

• Start date: 2023-09-20
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-09-25
• Last updated: 2023-09-25