Assessment of plaque morphology, structure, and stability in non-culprit lesions
Assessment of plaque morphology, structure, and stability in non-culprit lesions: Assessment of plaque morphology, structure, and stability in non-culprit lesions based on intravascular ultrasound and optical coherence tomography-near-infrared spectroscopy imaging technology.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Inclusion criteria for the clinical study:
1. Aged ≥18 years at enrollment, male or female;
2. Meets the diagnosis of acute coronary syndrome, including acute myocardial infarction and unstable angina. Acute myocardial infarction includes ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (non-STEMI). STEMI is defined as chest pain lasting at least 30 minutes, arriving at the hospital within 12 hours from the onset of symptoms, changes in the 12-lead ECG (ST-segment elevation \>0.1 mV in ≥2 consecutive leads or new left bundle branch block), and elevated cardiac biomarkers (troponin T/I). Non-STEMI is defined as ischemic symptoms without ST-segment elevation on ECG, accompanied by elevated cardiac biomarkers. Unstable angina is defined as chest pain lasting 5-30 minutes at rest, or worsening of exertional angina, and accompanied by one of the following: transient ST-segment depression or elevation; coronary angiography showing luminal narrowing ≥90% or plaque rupture or thrombotic lesions.
3. Planned to undergo coronary angiography and PCI treatment;
4. Hemodynamically stable and able to tolerate repeated intracoronary administration of nitroglycerin;
5. Capable of understanding the requirements of this study, willing to participate in the study, and have signed an informed consent form.
* Imaging inclusion criteria:
1. Coronary angiography clearly shows that the patient has at least one non-culprit lesion with a visual assessment of diameter stenosis between 40-70%, and the operator believes that interventional treatment intervention is not temporarily necessary;
2. The site of the non-culprit lesion has not previously had a stent implanted.
Exclusion Criteria:
* Exclusion criteria for the clinical study:
1. Cardiogenic shock or hemodynamic instability;
2. History of coronary artery bypass grafting (CABG), or planned CABG;
3. Severe renal impairment (glomerular filtration rate \<30ml/min/1.73m²);
4. Life expectancy of less than 2 years;
5. Currently participating in other ongoing investigative device or drug studies that have not yet reached their primary endpoints.
* 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.).
Primary outcome measure(s)
Total MACE at 2 years — 1 month,1year,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.
Trial sites (11)
Facility
City
Region
Status
Shenzhen People's Hospital
Shenzhen
Guandong
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Wuhan Asian Heart Hospital
Wuhan
Hubei
China-Japan Union Hospital of Jilin University
Changchun
Jilin
Xi'an Jiaotong University Second Affiliated Hospital
Xi'an
Shaanxi
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi
Xinjiang Uygur Autonomous Region
The Second Affiliated Hospital, Zhejiang University
Hangzhou
Zhejiang
Beijing Anzhen Hospital, Capital Medical University
Beijing
China
Beijing Jishuitan Hospital
Beijing
China
Fuwai Hospital, Chinese Academy of Medical Sciences
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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