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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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)

Treatment groups

900 Participants
are divided into 1 treatment group
Group A: CHD patients undergoing target lesion PCI1 intervention

Trial outcomes

Primary outcomes

1

coronary plaque progression

percent change in plaque volume measured by IVUS

Time frame
9 to 12 months after PCI

Secondary outcomes

1

carotid plaque progression

measured by carotid ultrasound

Time frame
9 to 12 months after PCI

Other outcomes

1

MACE

major adverse cardiovascular events

Time frame
9 to 12 months after PCI

Sponsors and contacts

Click on the lead sponsor to view all of their trials.