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

NCT06936111 | Recruiting

• 1 other identifier: B2024-377R
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• coronary plaque progression

  percent change in plaque volume measured by IVUS

  9 to 12 months after PCI

Secondary Outcomes (1)

• carotid plaque progression

  9 to 12 months after PCI

Other Outcomes (1)

• MACE

  9 to 12 months after PCI

Study Arms (1)

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

Diagnostic Test: Assessment of residual cholesterol and inflammatory risk factors

Interventions

Assessment of residual cholesterol and inflammatory risk factors DIAGNOSTIC_TEST

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

CHD patients undergoing target lesion PCI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).
• to 75 years old.
• Written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Chunfeng Dai, M.D.

CONTACT

86-021-64041990; dai.chunfeng@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 20, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)