Residual plaque risk during intensive cholesterol‑lowering in coronary heart disease
Effect of Residual Lipid and Inflammation Risk on Atherosclerotic Plaque Progression Under Intensive Lipid-lowering Therapy in Coronary Heart Disease
This project will follow people with coronary heart disease on intensive cholesterol‑lowering treatment to see if leftover lipid and inflammatory risks are linked to coronary plaque getting worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06936111 on ClinicalTrials.gov |
What this trial studies
Investigators will create a prospective cohort of patients with coronary heart disease who have undergone successful PCI and have non‑target lesions of 20–50% stenosis. Participants will undergo intravascular ultrasound (IVUS) imaging of non‑target lesions within the target vessel and serial measurement of lipid and inflammatory markers. Comprehensive clinical, laboratory, and imaging data will be collected with attention to medication adherence and relevant covariates. The goal is to link residual lipid and inflammatory risk profiles to plaque progression over follow‑up in a real‑world, well‑characterized population.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 years old with coronary artery disease who had successful PCI and have adjacent non‑target lesions with 20–50% stenosis and identifiable anatomic markers, and who can give informed consent.
Not a fit: Patients unlikely to benefit include those with familial hypercholesterolemia, long‑term immunosuppression or autoimmune disease, severe renal or hepatic failure, limited life expectancy, pregnancy, or those without qualifying non‑target lesions.
Why it matters
Potential benefit: If successful, the project could identify which patients still face plaque progression despite intensive lipid lowering and help target additional therapies to those at highest residual risk.
How similar studies have performed: Previous post‑hoc analyses of randomized trials have suggested links between residual lipid/inflammatory risks and plaque progression, but prospective cohorts with IVUS imaging are relatively scarce.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). * 18 to 75 years old. * Written informed consent. Exclusion Criteria: * 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.
Where this trial is running
Shanghai
- Shanghai Zhongshan Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Chunfeng Dai, M.D.
- Email: dai.chunfeng@zs-hospital.sh.cn
- Phone: 86-021-64041990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.