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.
Study Type
OBSERVATIONAL
Enrollment
500
Assessment of plaque morphology, structure, and stability in non-culprit lesions based on intravascular ultrasound and optical coherence tomography-near-infrared spectroscopy imaging technology.
Shenzhen People's Hospital
Shenzhen, Guandong, China
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
...and 1 more locations
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.
Time frame: 1 month,1year,2 years
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.
Time frame: 1 month,1year,2 years
Major Adverse Cardiovascular Events
MACE includes recurrent angina, acute myocardial infarction, severe arrhythmias, heart failure, coronary death, and so on.
Time frame: 1 month,1year,2 years,5 years
Death
Death includes all-cause mortality, cardiovascular mortality, non-cardiovascular mortality, and deaths of unknown causes.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 1 month,1year,2 years,5 years
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