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The goal of this observational study is to develop an automatic whole-process AI model to detect, quantify, and characterize plaques using coronary CT angiography in coronary artery disease patients. The main questions it aims to answer are:
Coronary artery disease (CAD) remains the leading cause of death worldwide. Atherosclerotic plaques play a pivotal role in CAD-related patient mortality. Thus, the detection, quantification, and characterization of coronary plaques are clinically significant for early prevention and interventions for CAD.
Coronary CT angiography (CCTA) has emerged as a robust noninvasive tool for the evaluation of CAD. In clinical practice, the coronary plaque assessment is performed by a time-consuming manual process dependent on the clinician's experience and subjective visual interpretation. With the development of artificial intelligence, many automatic computer-aided methods have been proposed to post-process the CCTA images. However, previously proposed algorithms of plaque evaluation were not developed based on intravascular ultrasound (IVUS) or optical coherence tomography (OCT), which were regarded as the gold reference for plaque evaluation. Thus, we aimed to develop a deep learning model in a whole-process automatic and intelligent system on CCTA to detect, quantify, and characterize plaques using IVUS or OCT as reference standard. Then we will work on the validation in different clinical scenarios: (1) Validation of the accuracy of the new deep learning model; (2) Prognosis of the model in different populations with CAD; (3) Impact of the model on guiding clincial therapies.
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who underwent coronary CT angiography and intravascular ultrasound within 3 months |
| ||
| Patients who underwent coronary CT angiography and optical coherence tomography within 3 months |
| ||
| Patients who underwent coronary CT angiography because of suspected or known coronary artery disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular imaging test | Diagnostic Test | Coronary artery disease patients first underwent CCTA and then intravascular imaging test within 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of AI-assisted coronary CT angiography on identifying vulnerable plaques compared to intravascular imaging | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Overall coronary plaque detection rate using intravascular ultrasound as reference standard | 1 day | |
| Total plaque volume | 1 day | |
| Changes in medical management following the addition of the AI model compared with routine CCTA results alone. |
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Inclusion Criteria:
Exclusion Criteria:
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consecutive patients who first underwent CCTA and then Intravascular imaging in China
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| Name | Affiliation | Role |
|---|---|---|
| Longjiang Zhang, MD | Jinling Hospital, Medical School of Nanjing University, Nanjing,China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute Of Medical Imaging Jinling Hospital | Nanjing | Jiangsu | 210018 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37464183 | Background | Follmer B, Williams MC, Dey D, Arbab-Zadeh A, Maurovich-Horvat P, Volleberg RHJA, Rueckert D, Schnabel JA, Newby DE, Dweck MR, Guagliumi G, Falk V, Vazquez Mezquita AJ, Biavati F, Isgum I, Dewey M. Roadmap on the use of artificial intelligence for imaging of vulnerable atherosclerotic plaque in coronary arteries. Nat Rev Cardiol. 2024 Jan;21(1):51-64. doi: 10.1038/s41569-023-00900-3. Epub 2023 Jul 18. | |
| 36151312 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Coronary plaque assessment | Diagnostic Test | Plaques on coronary CT angiography (CCTA) were quantified and characterized using the developed AI model. |
|
| 90 days |
| Background |
| Gaba P, Gersh BJ, Muller J, Narula J, Stone GW. Evolving concepts of the vulnerable atherosclerotic plaque and the vulnerable patient: implications for patient care and future research. Nat Rev Cardiol. 2023 Mar;20(3):181-196. doi: 10.1038/s41569-022-00769-8. Epub 2022 Sep 23. |
| 35174219 | Result | Zhou F, Chen Q, Luo X, Cao W, Li Z, Zhang B, Schoepf UJ, Gill CE, Guo L, Gao H, Li Q, Shi Y, Tang T, Liu X, Wu H, Wang D, Xu F, Jin D, Huang S, Li H, Pan C, Gu H, Xie L, Wang X, Ye J, Jiang J, Zhao H, Fang X, Xu Y, Xing W, Li X, Yin X, Lu GM, Zhang LJ. Prognostic Value of Coronary CT Angiography-Derived Fractional Flow Reserve in Non-obstructive Coronary Artery Disease: A Prospective Multicenter Observational Study. Front Cardiovasc Med. 2022 Jan 31;8:778010. doi: 10.3389/fcvm.2021.778010. eCollection 2021. |
| 42012347 | Derived | Chen Q, Zhou F, Xing W, Xu Y, Hu S, Pan T, Cao W, Guo L, Shi Y, Luo S, Xu L, Zhang J, Zhang S, Zheng C, Yang Z, Qiao HY, Guo B, Liu T, Xu P, Xu W, Zhong J, Xie G, Tao X, Lu G, Tang CX, Zhang JJ, Zhang LJ; China VALUE Study Group. A Fully Automated Deep Learning Model for Quantifying Coronary Plaque at Coronary CT Angiography. Radiology. 2026 Apr;319(1):e251967. doi: 10.1148/radiol.251967. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |