REsiduAL rISk Under Intensive Lipid-lowering Therapy In Coronary Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Assessment of residual cholesterol and inflammatory risk factors.
- Who it may be relevant to
- Registry conditions: Coronary Heart Disease (CHD). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Residual Lipid and Inflammation Risk on Atherosclerotic Plaque Progression Under Intensive Lipid-lowering Therapy in Coronary Heart Disease
Overview
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.
Interventions
- 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)
Primary outcome measures
- coronary plaque progression [Time frame: 9 to 12 months after PCI]
Secondary outcome measures (1)
- carotid plaque progression [Time frame: 9 to 12 months after PCI]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Zhongshan Hospital — Shanghai
Identifiers
NCT: NCT06936111 · B2024-377R