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| Name | Class |
|---|---|
| Shanghai Jiao Tong University -Pulse Medical Imaging Technology Joint Lab | UNKNOWN |
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To perform CT-QFR, invasive coronary angiography, FFR, and QFR tests on patients with moderate coronary stenosis after coronary CTA examination. Use FFR as a reference to verify the diagnostic performance of CT-QFR, and compare it with QFR.
This study is a prospective and single-center trial in China.It intends to enroll 216 patients with coronary artery disease whose coronary artery is determined to be 30-90% stenosis after coronary CT scan. CT image data will be imported for CT-QFR detection and undergo coronary angiography within 30 days. Quantitative analysis of coronary angiography (QCA) was performed with the degree of coronary stenosis. FFR and QFR were detected during the operation. Use FFR as a reference standard to verify the diagnostic performance of CT-QFR and QFR. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying hemodynamically significant coronary stenosis with FFR as the reference standard. Major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions. The completion of the project will provide patients with a practical non-invasive assessment method of coronary heart disease which provides the best treatment strategy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-QFR | Diagnostic Test | CT-QFR is a novel method for evaluating the functional significance of coronary stenosis. It is calculated by coronary computed tomographic angiography images. |
| |
| QFR | Diagnostic Test | QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two. angiographic projections. |
| |
| FFR | Diagnostic Test | FFR measured by pressure wire is the gold standard for evaluating the functional significance of coronary stenosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of CT-QFR | Diagnostic accuracy of on-site CT-QFR in identifying physiologically significant coronary artery stenosis, using FFR as the reference standard. Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80. | 1.5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparision between CT-QFR and QFR | Use FFR as a reference standard to validate the non-inferiority of CT-QFR compared with QFR in the vessels without extensively calcified lesions defined by the combination of a cross-sectional calcium arc >90° and a thickness >1.5 mm. For CT-QFR, QFR and FFR evaluations, vessels with <=0.80 are regarded as having hemodynamically significant CAD. | 1.5 year |
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Inclusion Criteria:
Exclusion Criteria:
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Enrolled patients are adults with suspected CAD who underwent clinically indicated ICA after CT which indicates moderate coronary artery stenosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinkai Qu, MD,PhD | Contact | +86 13916320399 | qxkchest@126.com | |
| Tingwen Weng, MD | Contact | +86 13917769721 | wengtingwen@alu.fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xinkai Qu, MD,PhD | Huadong Hospital, Department of Cardiology | Principal Investigator |
| Tingwen Weng, MD | Huadong Hospital, Department of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinkai Qu | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39432253 | Derived | Weng T, Ding D, Li G, Guan S, Han W, Gan Q, Li M, Qi L, Li C, Chen Y, Zhang L, Li T, Chang X, Chen Y, Wijns W, Qu X, Tu S. Accuracy of coronary computed tomography angiography-derived quantitative flow ratio for onsite assessment of coronary lesions. EuroIntervention. 2024 Oct 21;20(20):e1288-e1297. doi: 10.4244/EIJ-D-24-00336. | |
| 35738652 |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Other common measures of diagnostic performance of CT-QFR | Other common measures of diagnostic performance of CT-QFR, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) at the patient level compared with FFR as the reference standard. Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80. | 1.5 year |
| Correlation between CT-QFR and FFR | Pearson correlation or spearman's correlation will be used to quantify the correlations between CT-QFR and FFR. Agreements between CT-QFR and FFR will be assessed by Bland-Altman plot. The correlation coefficient r=0-0.2 represents very weak or no correlation. 0.2-0.4 represents weak correlation. 0.4-0.6 represents moderate correlation. 0.6-0.8 represents strong correlation. 0.8-1.0 represents very strong correlation. | 1.5 year |
| The comparison between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%) and QCA-derived DS% | The comparison of the discrimination ability between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%), and QCA-derived DS% for identifying physiologically significant stenosis with FFR as the reference standard. Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80. | 1.5 year |
| Weng T, Gan Q, Li Z, Guan S, Han W, Zhai X, Li M, Qi L, Li C, Chen Y, Zhang L, Chang X, Tu S, Qu X. Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol. BMJ Open. 2022 Jun 23;12(6):e055481. doi: 10.1136/bmjopen-2021-055481. |
| D014652 |
| Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |