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

Fudan University

Status: Enrolling

Conditions: Coronary Heart Disease (CHD)

Treatments: Diagnostic Test: Assessment of residual cholesterol and inflammatory risk factors

Study type: Observational

Funder types: Other

Identifiers

NCT06936111

B2024-377R

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

900 participants in 1 patient group

CHD patients undergoing target lesion PCI

Description:

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

Treatment:

Diagnostic Test: Assessment of residual cholesterol and inflammatory risk factors