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This study is a multicenter prospective observational clinical study, which will be conducted in 11 hospitals, and approximately 500 subjects will be enrolled. Plaque morphology and stability of non-culprit lesions were assessed by intravascular ultrasound (IVUS) and optical coherence tomography-near-infrared spectroscopy (OCT) after percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Plaques were grouped according to high-risk or non-high-risk. Clinical follow-up was conducted after PCI.
Plaque stability is an important criterion for selecting different treatment strategies (interventional and antithrombotic). High-risk plaque characteristics are also considered to be related to the overall incidence of Major Adverse Cardiovascular Events (MACE). Single-modality intravascular imaging has inherent disadvantages in identifying atherosclerotic plaques, while the combination of IVUS, OCT, and NIRS enables multimodal intravascular imaging techniques to complement each other in obtaining plaque information. There is currently a lack of research on the prognostic benefits of multimodal intravascular imaging in assessing atherosclerotic plaques. This study is a multicenter, prospective, observational clinical study that will be conducted at 11 hospitals, enrolling approximately 500 subjects. It will use intravascular ultrasound (IVUS) and optical coherence tomography-near-infrared spectroscopy (OCT) to assess the morphology and stability of non-culprit lesions in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI), and will follow up at 1 month, 1 year, 2 years, and 5 years post-surgery. The aim is to compare the clinical outcomes between high-risk and non-high-risk patients, as well as between high-risk and non-high-risk plaques defined by multimodal intravascular imaging, and to explore the predictive value of high-risk plaque characteristics shown by multimodal intravascular imaging for adverse cardiovascular events in patients with ACS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-risk Plaque Group | Multimodal intravascular imaging technology is used to assess the morphological structure and stability of non-criminal lesions in plaques, categorized into high-risk and non-high-risk groups. High-risk plaques are defined as those that meet any of the following criteria: ① IVUS minimum lumen area <4.0mm² or OCT minimum lumen area <3.5mm², ② plaque burden >70%, ③ presence of thin-cap fibroatheroma, ④ NIRS detects lipid-rich plaques with LRP MaxLCBI4mm >315, and are considered high-risk if they have at least two of the above four characteristics. A patient is placed in the high-risk group if they have at least one high-risk plaque. |
| |
| Non-high-risk Plaque Group | Multimodal intravascular imaging technology is used to assess the morphological structure and stability of non-criminal lesions in plaques, categorized into high-risk and non-high-risk groups. High-risk plaques are defined as those that meet any of the following criteria: ① IVUS minimum lumen area <4.0mm² or OCT minimum lumen area <3.5mm², ② plaque burden >70%, ③ presence of thin-cap fibroatheroma, ④ NIRS detects lipid-rich plaques with LRP MaxLCBI4mm >315, and are considered high-risk if they have at least two of the above four characteristics. If they have no high-risk plaques, they are placed in the non-high-risk group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of plaque morphology, structure, and stability in non-culprit lesions | Diagnostic Test | Assessment of plaque morphology, structure, and stability in non-culprit lesions based on intravascular ultrasound and optical coherence tomography-near-infrared spectroscopy imaging technology. |
| Measure | Description | Time Frame |
|---|---|---|
| Total MACE at 2 years | The total MACE (Major Adverse Cardiovascular Events) at 2 years post-surgery, including both culprit lesions and non-culprit lesions, is defined as a composite endpoint consisting of death, non-fatal myocardial infarction, and unplanned revascularization. | 1 month,1year,2 years |
| Measure | Description | Time Frame |
|---|---|---|
| CL-MACE at 2 years post-PCI; NCL-MACE at 2 years post-PCI | The CL-MACE at 2 years post-PCI and NCL-MACE at 2 years post-PCI, including both culprit lesions and non-culprit lesions, is defined as a composite endpoint consisting of death, non-fatal myocardial infarction, and unplanned revascularization. | 1 month,1year,2 years |
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Inclusion Criteria:
Inclusion criteria for the clinical study:
Imaging inclusion criteria:
Exclusion Criteria:
Exclusion criteria for the clinical study:
Imaging exclusion criteria:
The anatomical structure of the non-culprit lesion is not suitable for intravascular imaging catheter imaging (lesions at the left main trunk or right coronary artery ostium, severe calcification, chronic total occlusion, etc.).
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Patients with Acute Coronary Syndrome (ACS) who are planned for coronary angiography and interventional treatment. ACS includes acute ST-segment elevation myocardial infarction, acute non-ST-segment elevation myocardial infarction, and unstable angina.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Gao, MD, PHD | Contact | +86 13661022415 | +86 | nkgaolei2010@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yun Dai Chen, MD, PHD | People's Liberation Army General Hospital | Study Chair |
| Yong Zeng, PD | Beijing Anzhen Hospital | Principal Investigator |
| Lei Song |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People's Hospital | Shenzhen | Guandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37703036 | Result | Mol JQ, Volleberg RHJA, Belkacemi A, Hermanides RS, Meuwissen M, Protopopov AV, Laanmets P, Krestyaninov OV, Dennert R, Oemrawsingh RM, van Kuijk JP, Arkenbout K, van der Heijden DJ, Rasoul S, Lipsic E, Rodwell L, Camaro C, Damman P, Roleder T, Kedhi E, van Leeuwen MAH, van Geuns RM, van Royen N. Fractional Flow Reserve-Negative High-Risk Plaques and Clinical Outcomes After Myocardial Infarction. JAMA Cardiol. 2023 Nov 1;8(11):1013-1021. doi: 10.1001/jamacardio.2023.2910. | |
| 33714389 |
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blood serum
|
| Major Adverse Cardiovascular Events |
MACE includes recurrent angina, acute myocardial infarction, severe arrhythmias, heart failure, coronary death, and so on. |
| 1 month,1year,2 years,5 years |
| Death | Death includes all-cause mortality, cardiovascular mortality, non-cardiovascular mortality, and deaths of unknown causes. | 1 month,1year,2 years,5 years |
| Non-fatal Myocardial Infarction | Non-fatal Myocardial Infarction (NBMI) refers to an event where the heart muscle suffers severe ischemia and necrosis due to the acute occlusion of the coronary artery, but does not result in the patient's death. This type of heart attack is usually accompanied by changes on the electrocardiogram (ECG) and elevated cardiac biomarkers (such as troponin), but without significant elevation of the ST segment, which distinguishes it from ST-segment elevation myocardial infarction (STEMI). | 1 month,1year,2 years,5 years |
| Unplanned Revascularization | Unplanned revascularization is defined as revascularization performed outside the scope of the initial standard treatment for PCI, or staged revascularization that occurs more than 60 days (or the number of days planned by the surgeon) after the first PCI. Unplanned revascularization refers to PCI or CABG driven by persistent ischemic symptoms. | 1 month,1year,2 years,5 years |
| Any Revascularization | Any revascularization includes planned revascularization, unplanned revascularization, target lesion revascularization, ischemia-driven target lesion revascularization, and clinically driven target lesion revascularization. | 1 month,1year,2 years,5 years |
| Stent Thrombosis As Defined by ARC-2 | Stent thrombosis is classified by the time of occurrence into acute thrombosis (occurring within 24 hours after PCI), subacute thrombosis (occurring between 1-30 days after PCI), late thrombosis (occurring between 31 days and 365 days after PCI), or very late thrombosis (occurring more than 365 days after PCI). | 1 month,1year,2 years,5 years |
| Chinese Academy of Medical Sciences, Fuwai Hospital |
| Principal Investigator |
| Jun Jiang, MD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Yuquan He, MD | China-Japan Union Hospital, Jilin University | Principal Investigator |
| Wei Liu, MD | Beijing Jishuitan Hospital | Principal Investigator |
| Da Yin, MD | Shenzhen People's Hospital | Principal Investigator |
| Yining Yang, MD | People's Hospital of Xinjiang Uygur Autonomous Region | Principal Investigator |
| Jie Deng, MD | Xi'an Jiaotong University Second Affiliated Hospital | Principal Investigator |
| Ning Yang, MD | Tianjin Chest Hospital | Principal Investigator |
| Hua Yan | Wuhan Asian Heart Hospital | Principal Investigator |
| Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
|
| Wuhan Asian Heart Hospital | Wuhan | Hubei | China |
|
| China-Japan Union Hospital of Jilin University | Changchun | Jilin | China |
|
| Xi'an Jiaotong University Second Affiliated Hospital | Xi'an | Shaanxi | China |
|
| People's Hospital of Xinjiang Uygur Autonomous Region | Ürümqi | Xinjiang Uygur Autonomous Region | China |
| The Second Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang | China |
|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | China |
|
| Beijing Jishuitan Hospital | Beijing | China |
|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | China |
|
| People's Liberation Army General Hospital | Beijing | China |
|
| Result |
| Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X. |
| 34233996 | Result | Mol JQ, Belkacemi A, Volleberg RH, Meuwissen M, Protopopov AV, Laanmets P, Krestyaninov OV, Dennert R, Oemrawsingh RM, van Kuijk JP, Arkenbout K, van der Heijden DJ, Rasoul S, Lipsic E, Teerenstra S, Camaro C, Damman P, van Leeuwen MA, van Geuns RJ, van Royen N. Identification of anatomic risk factors for acute coronary events by optical coherence tomography in patients with myocardial infarction and residual nonflow limiting lesions: rationale and design of the PECTUS-obs study. BMJ Open. 2021 Jul 7;11(7):e048994. doi: 10.1136/bmjopen-2021-048994. |
| 34531027 | Result | Aguirre AD, Arbab-Zadeh A, Soeda T, Fuster V, Jang IK. Optical Coherence Tomography of Plaque Vulnerability and Rupture: JACC Focus Seminar Part 1/3. J Am Coll Cardiol. 2021 Sep 21;78(12):1257-1265. doi: 10.1016/j.jacc.2021.06.050. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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