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
Shanghai Zhongshan Hospital
900 participants
Jul 1, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Diagnosed with CAD and PCI was successfully performed.
- Presence of non-target lesions near the target lesion (more than 5mm proximal or distal), with stenosis of 20% to 50% and identifiable anatomical markers (e.g., branches, calcifications, stent edges).
- to 75 years old.
- Written informed consent.
Exclusion Criteria8
- Known autoimmune diseases, or taking immunosuppressive drugs for a long time before onset.
- Known familial hypercholesterolemia.
- Critical conditions (e.g., cardiogenic shock, acute heart failure).
- Severe renal insufficiency (eGFR \< 30 mL /(min·1.73m2)), or severe hepatic insufficiency (ALT or AST≥3 times the upper limit of normal).
- Severe underlying diseases (such as end-stage malignancies), life expectancy \< 1 year.
- Allergic to lipid-lowering medications.
- Pregnant, or trying to become pregnant, and breastfeeding women.
- Other conditions deemed unsuitable for inclusion by the researcher.
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Interventions
The prespecifed risk factors include CRP, SAA, TNF-α, IL-6, MCP-1, Lp-PLA2, PCSK-9, Lp(a)
Locations(1)
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NCT06936111