Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging

NCT ID: NCT06681155

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2031-12-31

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.

Conditions

Coronary Arterial Disease (CAD); Acute Coronary Syndromes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Assessment of plaque morphology, structure, and stability in non-culprit lesions

Intervention Type: 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.

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.

Assessment of plaque morphology, structure, and stability in non-culprit lesions

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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.

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

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.

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yun Dai Chen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yun Dai Chen, MD, PHD

Role: STUDY_CHAIR

People's Liberation Army General Hospital

Yong Zeng, PD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Lei Song

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Jun Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Yuquan He, MD

Role: PRINCIPAL_INVESTIGATOR

China-Japan Union Hospital, Jilin University

Wei Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Jishuitan Hospital

Da Yin, MD

Role: PRINCIPAL_INVESTIGATOR

Shenzhen People's Hospital

Yining Yang, MD

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Xinjiang Uygur Autonomous Region

Jie Deng, MD

Role: PRINCIPAL_INVESTIGATOR

Xi'an Jiaotong University Second Affiliated Hospital

Ning Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Chest Hospital

Hua Yan

Role: PRINCIPAL_INVESTIGATOR

Wuhan Asian Heart Hospital

Locations

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

People's Liberation Army General Hospital

Beijing, , China

Countries

China

Central Contacts

Lei Gao, MD, PHD

Role: CONTACT

nkgaolei2010@126.com

+86 13661022415 ext. +86

Facility Contacts

Da Yin, PD

Role: primary

Hesong Zeng, PD

Role: primary

Hua Yan, PD

Role: primary

Yuquan He, PD

Role: primary

Jie Deng, PD

Role: primary

Jun Jiang, PD

Role: primary

Yong Zeng, PD

Role: primary

Wei Liu, PD

Role: primary

Lei Song, PD

Role: primary

Yun Dai Chen, PD

Role: primary

References

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 33714389 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34233996 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34531027 (View on PubMed)

Other Identifiers

HZKY-PJ-2024-54

Identifier Type: -

Identifier Source: org_study_id