Clinical trial NCT06936111: REsiduAL rISk Under Intensive Lipid-lowering Therapy In Coronary Heart Disease
Official title: Effect of Residual Lipid and Inflammation Risk on Atherosclerotic Plaque Progression Under Intensive Lipid-lowering Therapy in Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Heart Disease (CHD)
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: coronary plaque progression
timeFrame: 9 to 12 months after PCI
Secondary outcomes:
measure: carotid plaque progression
timeFrame: 9 to 12 months after PCI
Other outcomes:
measure: MACE
timeFrame: 9 to 12 months after PCI
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
References: