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NCT Number: NCT06936111

REsiduAL rISk 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Zhongshan Hospital

Shanghai, China

Location status: Recruiting

Location contact

Chunfeng Dai, M.D.

CONTACT

[email protected]

86-021-64041990

Chunfeng Dai, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. coronary plaque progression

    Time frame: 9 to 12 months after PCI

    percent change in plaque volume measured by IVUS

Secondary outcomes

  1. carotid plaque progression

    Time frame: 9 to 12 months after PCI

    measured by carotid ultrasound

Other outcomes

  1. MACE

    Time frame: 9 to 12 months after PCI

    major adverse cardiovascular events

Study contacts

Contact information is provided by the study sponsor or research team.

Chunfeng Dai, M.D.

CONTACT

[email protected]

86-021-64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Acronym: REALISTIC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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