Actively Recruiting
Effect of Residual Lipid and Inflammation Risk on Atherosclerotic Plaque Progression Under Intensive Lipid-lowering Therapy in Coronary Heart Disease
Led by Shanghai Zhongshan Hospital · Updated on 2026-02-03
900
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating coronary heart disease (CHD) patients who receive intensive lipid-lowering therapy but still show progression of coronary plaque. The study aims to better understand how leftover lipid and inflammatory risks contribute to plaque growth. This research focuses on non-target lesions near treated areas in the heart and uses intravascular ultrasound (IVUS) to closely examine plaque changes. The study is observational and sponsored by Shanghai Zhongshan Hospital. The study will enroll CHD patients who have undergone successful percutaneous coronary intervention (PCI) on target lesions. It will observe non-target lesions near the treated site, which have specific narrowing and anatomical markers. Researchers will collect detailed data on cholesterol and inflammatory markers such as CRP, SAA, TNF-α, IL-6, MCP-1, Lp-PLA2, PCSK-9, and Lp(a) to assess their impact on plaque progression during intensive lipid-lowering therapy. Participants will be followed for 9 to 12 months after PCI to monitor coronary plaque progression using imaging and lab tests. The study also tracks carotid plaque progression as a secondary outcome. Data collection includes comprehensive clinical and laboratory assessments to evaluate residual risk factors. The total duration involves regular follow-up visits to monitor changes and ensure good compliance, aiming to provide new insights into residual risks under intensive lipid control.
CONDITIONS
Brief Title
REsiduAL rISk Under Intensive Lipid-lowering Therapy In Coronary Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with coronary artery disease and successfully underwent PCI
- Presence of non-target lesions near the treated lesion with 20% to 50% narrowing and identifiable anatomical markers
- Age between 18 and 75 years
- Provided written informed consent
You will not qualify if you...
- Known autoimmune diseases or long-term use of immunosuppressive drugs
- Known familial hypercholesterolemia
- Critical conditions such as cardiogenic shock or acute heart failure
- Severe kidney insufficiency (eGFR < 30 mL/min/1.73m2) or severe liver insufficiency (ALT or AST ≥3 times upper limit)
- Severe underlying diseases with life expectancy less than 1 year
- Allergy to lipid-lowering medications
- Pregnant, trying to become pregnant, or breastfeeding
- Other conditions considered unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month after screening
Participants undergo assessment of residual cholesterol and inflammatory risk factors including CRP, SAA, TNF-α, IL-6, MCP-1, Lp-PLA2, PCSK-9, and Lp(a).
1 to 2 visits depending on assessments
Duration - 9 to 12 months
Participants are observed for coronary and carotid plaque progression following PCI.
Periodic visits for monitoring during follow-up
Trial Site Locations
Total: 1 location
1
Shanghai Zhongshan Hospital
Shanghai, China
Actively Recruiting
Research Team
C
Chunfeng Dai, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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