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

NCT ID: NCT06936111

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-07-31

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.

Conditions

Coronary Heart Disease (CHD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CHD patients undergoing target lesion PCI

This study will enroll patients with CAD undergoing target lesion PCI, with appropriate non-target lesions near the target lesion, which served as the observed lesions

Assessment of residual cholesterol and inflammatory risk factors

Intervention Type: DIAGNOSTIC_TEST

The prespecifed risk factors include CRP, SAA, TNF-α, IL-6, MCP-1, Lp-PLA2, PCSK-9, Lp(a)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chunfeng Dai

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Zhongshan Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunfeng Dai, M.D.

Role: CONTACT

dai.chunfeng@zs-hospital.sh.cn

86-021-64041990

Facility Contacts

Chunfeng Dai, M.D.

Role: primary

dai.chunfeng@zs-hospital.sh.cn

86-021-64041990

Other Identifiers

B2024-377R

Identifier Type: -

Identifier Source: org_study_id