About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Assessment of residual cholesterol and inflammatory risk factors
Diagnostic testThe prespecifed risk factors include CRP, SAA, TNF-α, IL-6, MCP-1, Lp-PLA2, PCSK-9, Lp(a)
Treatment groups
Trial outcomes
Primary outcomes
coronary plaque progression
percent change in plaque volume measured by IVUS
Secondary outcomes
carotid plaque progression
measured by carotid ultrasound
Other outcomes
MACE
major adverse cardiovascular events
Sponsors and contacts
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