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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS) | Diagnostic Test | pressure wire-based fractional flow reserve (FFR); intravascular ultrasound (IVUS)-based ultrasonic flow ratio (UFR) |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients ≥ 18 years of age who will be admitted for coronary angiography and had an indication for FFR measurement at the FuWai Hospital, Beijing, China, due to stable angina or unstable angina will be consecutively enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Qian, MD | Contact | +8613601396650 | qianjfw@163.com | |
| Cheng Yang, MD | Contact | +8619801116690 | yangcheng_fw@163.com |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| D014652 |
| Vascular Diseases |