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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06936111
Acronym
REALISTIC
Enrollment
900
Registered
2025-04-20
Start date
2025-07-01
Completion date
2027-07-01
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease (CHD)

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.

Interventions

DIAGNOSTIC_TESTAssessment 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)

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
coronary plaque progression9 to 12 months after PCIpercent change in plaque volume measured by IVUS

Secondary

MeasureTime frameDescription
carotid plaque progression9 to 12 months after PCImeasured by carotid ultrasound

Countries

China

Contacts

CONTACTChunfeng Dai, M.D.
dai.chunfeng@zs-hospital.sh.cn86-021-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026