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

Not yet recruiting

• Conditions: Coronary Artery Stenosis

• Registration Number: NCT06052670
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-12
• Study Start: 2023-09-20
• Study First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Study First Posted: 2023-09-25
• Last Update Posted: 2023-09-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 408

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard	Immediately after the procedure	Sensitivity is defined as the proportion of UFR ≤ 0.80 in patients with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR \> 0.80 in patients without hemodynamically-significant stenosis as measured by FFR (FFR \> 0.80).

Secondary Outcome Measures

Name	Time	Method
The AUC of UFR for coronary stenosis with FFR as the gold standard	Immediately after the procedure	AUC is defined as the area under the receiver-operating characteristic curve
Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the vessel level, using FFR as the reference standard	Immediately after the procedure	Sensitivity is defined as the proportion of UFR ≤ 0.80 in vessels with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR \> 0.80 in vessels without hemodynamically-significant stenosis as measured by FFR (FFR \> 0.8).
Diagnostic accuracy of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard	Immediately after the procedure	Diagnostic accuracy is defined as UFFR (≤0.80 or \>0.80) to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or \>0.8) as the reference standard.