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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
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This study aims to evaluate the accuracy of IVUS-calculated percent atheroma volume (PAV) for diagnosing functional myocardial ischemia, using FFR as the gold standard.
This prospective, single-site, single-group target-value study aims to investigate the accuracy of intravascular ultrasound (IVUS)-based plaque characteristics in diagnosing functional myocardial ischemia, using coronary fractional flow reserve (FFR) as the gold standard.
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of PAV calculated from IVUS images on diagnosing functional myocardial ischemia | Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy of PAV calculated from IVUS images on diagnosing functional myocardial ischemia PAV ≥ 39.0% is positive, PAV < 39.0% is negative). | Intraoperative period（After coronary angiography, before the potential PCI） |
| Sensitivity and specificity of PAV calculated from IVUS images on diagnosing functional myocardial ischemia | Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the sensitivity and specificity of PAV calculated from IVUS images on diagnosing functional myocardial ischemia (PAV ≥ 39.0% is positive, PAV < 39.0% is negative). | Intraoperative period（After coronary angiography, before the potential PCI） |
| Measure | Description | Time Frame |
|---|---|---|
| The positive predictive value, negative predictive value, Receiver Operating Characteristic Curve (ROC) and Area Under the Curve (AUC) of PAV calculated from IVUS images on the diagnosis of functional myocardial ischemia. | Using blood vessels as the research unit and FFR values measured by pressure microcatheters as reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the positive predictive value, negative predictive value, Receiver Operating Characteristic Curve (ROC), and Area Under the Curve (AUC) of PAV calculated from IVUS images on the diagnosis of functional myocardial ischemia (PAV ≥ 39.0% is positive, PAV < 39.0% is negative). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with multivessel coronary artery disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital,Cams & Pumc | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Intraoperative period（After coronary angiography, before the potential PCI） |
| Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Total Atheroma Volume (TAV) calculated from IVUS images on the diagnosis of functional myocardial ischemia | Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Total Atheroma Volume (TAV) calculated from IVUS images on the diagnosis of functional myocardial ischemia. | Intraoperative period（After coronary angiography, before the potential PCI） |
| Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Minimum Lumen Area (MLA) calculated from IVUS images on the diagnosis of functional myocardial ischemia | Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Minimum Lumen Area (MLA) calculated from IVUS images on the diagnosis of functional myocardial ischemia. | Intraoperative period（After coronary angiography, before the potential PCI） |
| Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Plaque Burden (PB) calculated from IVUS images on the diagnosis of functional myocardial ischemia | Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Plaque Burden (PB) calculated from IVUS images on the diagnosis of functional myocardial ischemia. | Intraoperative period（After coronary angiography, before the potential PCI） |
| Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Diameter Stenosis (DS%) calculated by Quantitative Coronary Angiography (QCA) on diagnosing functional myocardial ischemia | Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR>0.8 is negative), evaluate the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Diameter Stenosis degree (DS%) calculated by Quantitative Coronary Angiography (QCA) on diagnosing functional myocardial ischemia. | Intraoperative period（After coronary angiography, before the potential PCI） |
| Correlation between PAV, TAV, MLA, PB, DS% and FFR in pairwise comparisons | Using blood vessels as the research unit, conducting Passing Bablok regression analysis and Pearson linear correlation analysis on Percent Atheroma Volume (PAV), Total Atheroma Volume (TAV), Minimum Lumen Area (MLA), Plaque Burden (PB), Diameter Stenosis degree (DS%) and Fractional Flow Reserve (FFR). | Intraoperative period（After coronary angiography, before the potential PCI） |
| Correlation between PAV gradient calculated from IVUS images and FFR Pullback Pressure Gradient (PPG) | Using blood vessels as the research unit, PAV was calculated every 1mm along the vascular direction based on IVUS images, and FFR Pullback Pressure Gradient (PPG) distribution was calculated based on FFR pullback. The correlation between PAV gradient distribution along the vascular direction and FFR PPG was evaluated. | Intraoperative period（After coronary angiography, before the potential PCI） |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |