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This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant left main (LM) coronary stenosis 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 120 patients with intermediated left main 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 left main 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 | UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard | Diagnostic accuracy is defined as UFFR (≤0.80 or >0.80) to identify hemodynamically-significant left main coronary stenosis with FFR (≤0.80 or >0.80) as the reference standard. | Immediately after the procedure |
| Sensitivity and specificity of UFR in predicting functionally significant left main coronary stenosis, 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 > 0.80). | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of sensitivity and specificity of UFR and IVUS-derived minimal lumen area (MLA) in predicting functionally significant left main coronary stenosis, 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 > 0.80). |
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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 |
| Name | Affiliation | Role |
|---|---|---|
| Jie Qian | Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Select A State | 100037 | China |
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| Immediately after the procedure |
| The AUC of UFR for left main coronary stenosis with FFR as the gold standard | AUC is defined as the area under the receiver-operating characteristic curve. | Immediately after the procedure |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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