NCT06936111Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 900 (estimated)
- First submitted
- 12 Apr 2025
- Start date
- 1 Jul 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06936111
What you commit to
- Study type: Observational
- Planned participants: 900
- From 1 Jul 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known autoimmune diseases, or taking immunosuppressive drugs for a long time before onset.
- Critical conditions (e.g., cardiogenic shock, acute heart failure).
- Severe underlying diseases (such as end-stage malignancies), life expectancy \< 1 year.
- Allergic to lipid-lowering medications.
- Other conditions deemed unsuitable for inclusion by the researcher.
Lab values
- Severe renal insufficiency (eGFR \< 30 mL /(min·1.73m2)), or severe hepatic insufficiency (ALT or AST≥3 times the upper limit of normal).
Other
- Known familial hypercholesterolemia.
- Pregnant, or trying to become pregnant, and breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.