REsiduAL rISk Under Intensive Lipid-lowering Therapy In Coronary Heart Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Assessment of residual cholesterol and inflammatory risk factors

Treatment groups

900 Participants
are divided into 1 treatment group

Sponsors and collaborators