Clinical trial NCT06681155: Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging
Official title: A Prospective Cohort Study on the Identification of High-Risk Coronary Plaque by Multimodality Intravascular Imaging(PlaqueVision Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Arterial Disease (CAD)
Acute Coronary Syndromes
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Total MACE at 2 years
timeFrame: 1 month,1year,2 years
Secondary outcomes:
measure: CL-MACE at 2 years post-PCI; NCL-MACE at 2 years post-PCI
timeFrame: 1 month,1year,2 years
measure: Major Adverse Cardiovascular Events
timeFrame: 1 month,1year,2 years,5 years
measure: Death
timeFrame: 1 month,1year,2 years,5 years
measure: Non-fatal Myocardial Infarction
timeFrame: 1 month,1year,2 years,5 years
measure: Unplanned Revascularization
timeFrame: 1 month,1year,2 years,5 years
measure: Any Revascularization
timeFrame: 1 month,1year,2 years,5 years
measure: Stent Thrombosis As Defined by ARC-2
timeFrame: 1 month,1year,2 years,5 years
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guandong
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Asian Heart Hospital
state: Hubei
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: Xi'an Jiaotong University Second Affiliated Hospital
state: Shaanxi
city: Ürümqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang Uygur Autonomous Region
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: People's Liberation Army General Hospital
Study officials:
affiliation: People's Liberation Army General Hospital
name: Yun Dai Chen, MD, PHD
role: STUDY_CHAIR
affiliation: Beijing Anzhen Hospital
name: Yong Zeng, PD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Lei Song
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jun Jiang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: China-Japan Union Hospital, Jilin University
name: Yuquan He, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Jishuitan Hospital
name: Wei Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen People's Hospital
name: Da Yin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Xinjiang Uygur Autonomous Region
name: Yining Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xi'an Jiaotong University Second Affiliated Hospital
name: Jie Deng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Chest Hospital
name: Ning Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Asian Heart Hospital
name: Hua Yan
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.