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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Stenosis

Intervention / Treatment
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* Diagnostic Test: fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard | 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). | Immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the vessel level, using FFR as the reference standard | 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). | Immediately after the procedure | 
| Diagnostic accuracy of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard | 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. | Immediately after the procedure | 
| The AUC of UFR for coronary stenosis with FFR as the gold standard | AUC is defined as the area under the receiver-operating characteristic curve | Immediately after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravascular ultrasound, ultrasonic flow ratio, fractional flow reserve