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Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging | Clinical Trials | Clareo Health

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Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging

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

NCT06681155•Chinese PLA General Hospital

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.).

Locations (11)

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

Key Dates

Start Date

November 1, 2024

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2031

Last Updated

November 8, 2024

Enrollment

500

ESTIMATED participants

Conditions

Coronary Arterial Disease (CAD)Acute Coronary Syndromes

Interventions

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

DIAGNOSTIC_TEST

Contacts

Lei Gao, MD, PHD

CONTACT

+86 13661022415 nkgaolei2010@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging

Inclusion Criteria

Exclusion Criteria

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