Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Total MACE at 2 years [Срок оценки: 1 month,1year,2 years]

Вторичные конечные точки (7)

• CL-MACE at 2 years post-PCI; NCL-MACE at 2 years post-PCI [Срок оценки: 1 month,1year,2 years]
• Major Adverse Cardiovascular Events [Срок оценки: 1 month,1year,2 years,5 years]
• Death [Срок оценки: 1 month,1year,2 years,5 years]
• Non-fatal Myocardial Infarction [Срок оценки: 1 month,1year,2 years,5 years]
• Unplanned Revascularization [Срок оценки: 1 month,1year,2 years,5 years]
• Any Revascularization [Срок оценки: 1 month,1year,2 years,5 years]
• Stent Thrombosis As Defined by ARC-2 [Срок оценки: 1 month,1year,2 years,5 years]

Критерии участия

Критерии включения

• Inclusion criteria for the clinical study:

• Aged ≥18 years at enrollment, male or female;
• 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.
• Planned to undergo coronary angiography and PCI treatment;
• Hemodynamically stable and able to tolerate repeated intracoronary administration of nitroglycerin;
• Capable of understanding the requirements of this study, willing to participate in the study, and have signed an informed consent form.
• Imaging inclusion criteria:

• 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;
• The site of the non-culprit lesion has not previously had a stent implanted.

Критерии исключения

• Exclusion criteria for the clinical study:

• Cardiogenic shock or hemodynamic instability;
• History of coronary artery bypass grafting (CABG), or planned CABG;
• Severe renal impairment (glomerular filtration rate <30ml/min/1.73m²);
• Life expectancy of less than 2 years;
• 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.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 11 центров

• Shenzhen People's Hospital — Шэньчжэнь
• Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and T — Ухань
• Wuhan Asian Heart Hospital — Ухань
• China-Japan Union Hospital of Jilin University — Changchun
• Xi'an Jiaotong University Second Affiliated Hospital — Сиань
• People's Hospital of Xinjiang Uygur Autonomous Region — Ürümqi
• The Second Affiliated Hospital, Zhejiang University — Ханчжоу
• Beijing Anzhen Hospital, Capital Medical University — Пекин
• … и ещё 3 центра

Публикации

• 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. PMID 37703036
• 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 PMID 33714389
• 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 PMID 34233996
• 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. PMID 34531027

Идентификаторы

NCT: NCT06681155 · HZKY-PJ-2024-54

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗