Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging (PlaqueVision)

A Prospective Cohort Study on the Identification of High-Risk Coronary Plaque by Multimodality Intravascular Imaging(PlaqueVision Study)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Coronary Syndromes; Coronary Arterial Disease (CAD)
• Intervention / Treatment: Diagnostic test: Assessment of plaque morphology, structure, and stability in non-culprit lesions

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Lei Gao, MD, PHD; Phone Number: +86 +86 13661022415; Email: nkgaolei2010@126.com

Study Locations

• China
  • Beijing, China
    • Beijing Jishuitan Hospital
    • Contact: Wei Liu, PD
  • Beijing, China
    • Beijing Anzhen Hospital, Capital Medical University
    • Contact: Yong Zeng, PD
  • Beijing, China
    • Fuwai Hospital, Chinese Academy of Medical Sciences
    • Contact: Lei Song, PD
  • Beijing, China
    • People's Liberation Army General Hospital
    • Contact: Yun Dai Chen, PD
  • Guandong
    • Shenzhen, Guandong, China
      • Shenzhen People's Hospital
      • Contact: Da Yin, PD
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Asian Heart Hospital
      • Contact: Hua Yan, PD
    • Wuhan, Hubei, China
      • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Hesong Zeng, PD
  • Jilin
    • Changchun, Jilin, China
      • China-Japan Union Hospital of Jilin University
      • Contact: Yuquan He, PD
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Xi'an Jiaotong University Second Affiliated Hospital
      • Contact: Jie Deng, PD
  • Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang Uygur Autonomous Region, China
      • People's Hospital of Xinjiang Uygur Autonomous Region
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital, Zhejiang University
      • Contact: Jun Jiang, PD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: 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.
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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Study Chair: Yun Dai Chen, MD, PHD, People's Liberation Army General Hospital; Principal Investigator: Yong Zeng, PD, Beijing Anzhen Hospital; Principal Investigator: Lei Song, 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: HZKY-PJ-2024-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No