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

Effect of Residual Lipid and Inflammation Risk on Atherosclerotic Plaque Progression Under Intensive Lipid-lowering Therapy in Coronary Heart Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Heart Disease (CHD)
• Intervention / Treatment: Diagnostic test: Assessment of residual cholesterol and inflammatory risk factors

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Chunfeng Dai, M.D.; Phone Number: 86-021-64041990; Email: dai.chunfeng@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Zhongshan Hospital
    • Contact: Chunfeng Dai, M.D.; Phone Number: 86-021-64041990; Email: dai.chunfeng@zs-hospital.sh.cn
    • Principal Investigator: Chunfeng Dai, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The prespecifed risk factors include CRP, SAA, TNF-α, IL-6, MCP-1, Lp-PLA2, PCSK-9, Lp(a)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
coronary plaque progression	percent change in plaque volume measured by IVUS	9 to 12 months after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
carotid plaque progression	measured by carotid ultrasound	9 to 12 months after PCI

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	major adverse cardiovascular events	9 to 12 months after PCI

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 12, 2025
• First Submitted That Met QC Criteria: April 12, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: B2024-377R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The research involves some confidential content

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No