NCT06681155

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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-12-01
• Completion: 2031-12-01
• First posted: 2024-11-08
• Last updated: 2024-11-08

Locations

11 sites across 1 country: China