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| Name | Class |
|---|---|
| Shengshi Technology, Co., Ltd, Hangzhou, China | UNKNOWN |
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The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive performance of FFRCT for myocardial ischemia were calculated per-patient level and per-vessel level with invasive FFR value as gold standard.
The present study is a single arm, open label, prospective trial. Measurement of FFR during invasive cardiac catheterization represents the "gold standard" for assessment of the hemodynamic significance of coronary artery lesions. As we know, the major disadvantage of FFR is that it has to be measured invasively. CardioSimFFRct Analysis software is a non-invasive method to determine FFR which computes the hemodynamic significance of Coronary Artery Disease (FFRCT) from coronary computed tomography angiography(CCTA)data of the subject by using computational fluid dynamics.The FFR derived from FFR-CT will be compared with invasive FFR as gold standard.Moreover CardioSimFFRct also simplifies the coronary artery into a one-dimensional piping model, omits grid engineering, and greatly reduces the complexity of pretreatment.Based on the pressure loss along the pipe flow and the local pressure loss, a fast method for FFR calculation in engineering is proposed. The calculation time can be reduced to several minutes.
FFRct from CardioSimFFRct Analysis software is mainly based on CCTA images to image the coronary arteries. Through three-dimensional reconstruction of the coronary arteries and computational fluid Dynamics (CFD) technology, the simulation of blood flow in the blood vessels is realized to extract the coronary blood flow reserve score (FFR).FFRct has the following characteristics such as the FFR value can be measured noninvasively, without additional damage to patients, avoiding the risks brought by invasive surgery, and the side effects brought by drugs during invasive surgery.FFRct can realize the examination quickly, save the time of doctors' coronary functional assessment, and simplify the process of coronary functional assessment.It also has the function of three-dimensional reconstruction of blood vessels, which makes it convenient for users to view the whole structure of coronary arteries and make artificial correction.The results of FFRct have high repeatability and are easy for users to evaluate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed with Coronary Artery Disease(CAD)by CCTA | Experimental | Patients admitted to hospital with the diagnosed of CAD by CCTA and who accept to participate to the study will undergo the invasive coronary angiography, fractional flow reserve (FFR) will be measured during the invasive coronary angiography.Outcome measures were comparing FFRct to FFR. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR and FFRCT | Diagnostic Test | All the patients will undergo computed coronary tomography angiography to analysis FFRCT . Then FFR will be measured during invasive cardiac catheterization. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity (subject level) of FFRCT | Sensitivity and specificity (subject level) for predicting the functional significance of coronary artery stenosis using CT-Derived Fractional Flow Reserve Score Analysis Software. | Measurement at Procedure/Baseline Visit |
| Measure | Description | Time Frame |
|---|---|---|
| AUC between FFRCT vs. FFR | Comparing the Area Under Curve(AUC) between FFRct and CCTA to determine the Functional significance of coronary stenosis. | Measurement at Procedure/Baseline Visit |
| Sensitivity and Specificity between FFRCT vs. FFR |
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Inclusion Criteria:
Subjects that participate in this study must fulfill all the following criteria:
General inclusion criteria:
Angiographic inclusion criteria:
Exclusion Criteria:
If subjects fulfill any of below criteria, this subject shall be exclude from this study.
General exclusion criteria:
Angiographic exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaling Han, professor | Contact | +86-024-28851120 | hanyaling@263.net |
| Name | Affiliation | Role |
|---|---|---|
| Yaling Han, professor | The General Hospital of Northern Theater Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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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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Comparing the Sensitivity and Specificity which at the lesion level between FFRct and CCTA
| Measurement at Procedure/Baseline Visit |
| Accuracy (lesion level and subject level) between FFRCT vs. FFR | Comparing the Accuracy which at the lesion level and subject level between FFRct and CCTA | Measurement at Procedure/Baseline Visit |
| Positive Predictive Value (PPV) between FFRCT vs. FFR | Comparing the positive predictive value (PPV) between FFRct and CCTA | Measurement at Procedure/Baseline Visit |
| Negative Predictive Value (NPV) between FFRCT vs. FFR | Comparing the negative predictive value (NPV) between FFRct and CCTA | Measurement at Procedure/Baseline Visit |
| Wuhan Asia Heart Hospital | Wuhan | Hubei | China |
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| Nanjing First Hospital | Nanjing | Jiangsu | China |
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| The Second Hospital of Jilin University | Changchun | Jilin | China |
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| The Second Hospital of Dalian University | Dalian | Liaoning | China |
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| General Hospital of Northern Theater Command | Shenyang | Liaoning | China |
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| Tianjin Chest Hospital | Tianjing | Tianjing | China |
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| The First Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
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| D014652 |
| Vascular Diseases |