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| Name | Class |
|---|---|
| School of Biomedical Engineering, Shanghai Jiao Tong University | UNKNOWN |
| Erasmus Medical Center | OTHER |
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Investigating the diagnostic accuracy of online Ultrasonic Flow Ratio (UFR) assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived fractional flow reserve (FFR) as a reference standard.
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Onsite UFR | UFR was computed as the pressure ratio across a coronary stenosis, using FFR ≤0.80 as the reference standard for hemodynamically significant stenosis. The diagnostic performance of onsite UFR was assessed by the area under the receiver operating characteristic (ROC) curve analysis, with diagnostic accuracy defined as the percentage of all correctly classified cases (true positives and true negatives) in the total population. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Onsite UFR | The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Sensitivity was defined as the percentage of true positives correctly identified by UFR. | baseline |
| Specificity of Onsite UFR |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with suspected ischemic heart disease who undergo coronary angiography.
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| Name | Affiliation | Role |
|---|---|---|
| Fenghua Ding, MD, PhD | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42145031 | Derived | Liu L, Yu L, Ding D, Huang K, Wang A, Hou X, Yu W, Zhang R, Daemen J, Ding F, Tu S. Diagnostic Accuracy of Artificial Intelligence-Enhanced Ultrasonic Flow Ratio for On-Site Assessment of Coronary Stenosis. JACC Asia. 2026 May 11:S2772-3747(26)00268-1. doi: 10.1016/j.jacasi.2026.04.011. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Assessment in Patients With Suspected Ischemic Heart Disease | Onsite Ultrasonic Flow Ratio (UFR) and Fractional Flow Reserve (FFR) Assessment in Patients with Suspected Ischemic Heart Disease |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Functional Assessment in Patients With Suspected Ischemic Heart Disease | Onsite UFR and FFR Assessment in Patients with Suspected Ischemic Heart Disease |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Six participants were excluded according to the predefined exclusion criteria. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diagnostic Accuracy of Onsite UFR | UFR was computed as the pressure ratio across a coronary stenosis, using FFR ≤0.80 as the reference standard for hemodynamically significant stenosis. The diagnostic performance of onsite UFR was assessed by the area under the receiver operating characteristic (ROC) curve analysis, with diagnostic accuracy defined as the percentage of all correctly classified cases (true positives and true negatives) in the total population. | Six participants were excluded according to the predefined exclusion criteria. | Posted | Number | 95% Confidence Interval | percentage of correctly classified cases | baseline |
|
Not monitored as this is a prospective observational study without any intervention.
Adverse events were not systematically collected or assessed as primary or secondary outcomes in this observational study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Functional Assessment in Patients With Suspected Ischemic Heart Disease | Onsite UFR and FFR Assessment in Patients with Suspected Ischemic Heart Disease |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fenghua Ding | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China | +00 86 21 64370045 | ruijindfh@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2022 | Aug 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Specificity was defined as the percentage of true negatives correctly identified by UFR. |
| baseline |
| Sensitivity of Minimal Lumen Area (MLA) | The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Sensitivity was defined as the percentage of true positives correctly identified by the prespecified MLA cutoff value. | baseline |
| Specificity of MLA | The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Specificity was defined as the percentage of true negatives correctly identified by the prespecified MLA cutoff value. | baseline |
| Median |
| Inter-Quartile Range |
| years |
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| Sex: Female, Male | Six participants were excluded according to the predefined exclusion criteria. | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Body Mass Index (BMI) | Six participants were excluded according to the predefined exclusion criteria. | Mean | Standard Deviation | Kg/m^2 |
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| Secondary | Sensitivity of Onsite UFR | The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Sensitivity was defined as the percentage of true positives correctly identified by UFR. | Six participants were excluded according to the predefined exclusion criteria. | Posted | Number | 95% Confidence Interval | percentage of true positives | baseline |
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| Secondary | Specificity of Onsite UFR | The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Specificity was defined as the percentage of true negatives correctly identified by UFR. | Six participants were excluded according to the predefined exclusion criteria. | Posted | Number | 95% Confidence Interval | percentage of true negatives | baseline |
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| Secondary | Sensitivity of Minimal Lumen Area (MLA) | The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Sensitivity was defined as the percentage of true positives correctly identified by the prespecified MLA cutoff value. | Six participants were excluded according to the predefined exclusion criteria. | Posted | Number | 95% Confidence Interval | percentage of true positives | baseline |
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| Secondary | Specificity of MLA | The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Specificity was defined as the percentage of true negatives correctly identified by the prespecified MLA cutoff value. | Six participants were excluded according to the predefined exclusion criteria. | Posted | Number | 95% Confidence Interval | percentage of true negatives | baseline |
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