NCT06936111

REsiduAL rISk Under Intensive Lipid-lowering Therapy In Coronary Heart Disease

Effect of Residual Lipid and Inflammation Risk on Atherosclerotic Plaque Progression Under Intensive Lipid-lowering Therapy in Coronary Heart Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Intensive lipid-lowering therapy is a cornerstone treatment for coronary heart disease (CHD). However, coronary plaque progression persists in a subset of patients even under intensive lipid-lowering therapy, which may be associated with residual lipid and inflammatory risks. Current research in this area remains largely confined to post hoc analyses of randomized controlled trials , with a notable scarcity of prospective follow-up cohorts. The investigators propose that establishing a prospective cohort will provide more authentic insights into the associations between residual risk factors and plaque progression. In this project, the investigators aim to establish a well-characterized CHD cohort with comprehensive data collection, good compliance, and an appropriate sample size. By focusing on non-target lesions within the target vessel and utilizing intravascular ultrasound (IVUS), the investigators will investigate the impact of residual lipid and inflammatory risks on plaque progression during intensive lipid-lowering therapy.

Conditions

• Coronary Heart Disease (CHD)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Assessment of residual cholesterol and inflammatory risk factors	The prespecifed risk factors include CRP, SAA, TNF-α, IL-6, MCP-1, Lp-PLA2, PCSK-9, Lp(a)

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-01-01
• Completion: 2027-07-01
• First posted: 2025-04-20
• Last updated: 2026-02-03

Locations

1 site across 1 country: China