NCT06936111 REsiduAL rISk Under Intensive Lipid-lowering Therapy In Coronary Heart Disease
| NCT ID | NCT06936111 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Coronary Heart Disease (CHD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2025-07-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06936111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Coronary Heart Disease (CHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06936111 currently recruiting?
Yes, NCT06936111 is actively recruiting participants. Contact the research team at dai.chunfeng@zs-hospital.sh.cn for enrollment information.
Where is the NCT06936111 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06936111 clinical trial?
NCT06936111 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 900 participants.