Relation Among HDL Functionality, Neoatherosclerosis and Target Lesion Revascularization

NCT ID: NCT03540381

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 181 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-01
• Study Completion Date: 2017-07-31

Brief Summary

The aim of this study is to evaluate the relation among cholesterol uptake capacity which measure HDL functionality, neoathrosclerosis and target-lesion revascularization.

Detailed Description

Intracoronary stent implantation has markedly reduced the incidence of restenosis in patients with coronary artery disease. However, in-stent restenosis requiring target-lesion revascularization (TLR) occurs even with the use of drug-eluting stents. Emerging evidence suggests that among various potential risk factors, atherogenic progression within the neointima, "neoatherosclerosis" is one of the major contributors to TLR, and that patients' lipid profile is one of the key risk factors for the development of neoatherosclerosis.

Conversely, recent animal and human studies have demonstrated the importance of high-density lipoprotein (HDL) functionality, rather than of HDL-cholesterol levels, in the development of de novo coronary artery disease. Cholesterol efflux capacity, a measure of the ability of HDL to promote cholesterol removal from lipid-laden macrophages, was found to be inversely correlated with the incidence of cardiovascular events and was shown to improve cardiovascular risk prediction beyond that with the use of traditional coronary risk factors. Therefore, the investigators hypothesized that the HDL function of promoting cholesterol removal from lipid-laden macrophages could be associated with TLR through its effect on the process of neoatherosclerosis progression within stents.

Recently, the investigators developed a rapid cell-free assay system to directly evaluate the capacity of HDL to accept additional cholesterol; the measurement of this cholesterol uptake capacity (CUC) enables HDL functionality to be readily evaluated in our daily practice. Thus, the investigators performed this study in order to clarify the potential relationship among CUC, neoatherosclerosis, and TLR by using the novel cell-free assay system, CUC measurement, and optical coherence tomography (OCT) analysis.

Conditions

Coronary Artery Disease Progression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Identified neoatherosclerosis group

From the patients treated with coronary stents, the investigators functionally evaluated their HDL by measuring the CUC. the investigators also performed follow-up OCT to evaluate the presence of neoatherosclerosis. Consecutive patients were divided into two groups. The patients with neoatherosclerosis were identified neoatherosclerosis group and the remaining were not-identified neoatherosclerosis group. After that, clinical follow-up was performed to assess TLR and the investigators examined the relation between CUC, neoatherosclerosis and TLR.

neoatherosclerosis

Intervention Type: OTHER

Not-identified neoatherosclerosis group

No interventions assigned to this group

Interventions

neoatherosclerosis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of coronary artery disease
• Patients who had undergone percutaneous coronary intervention
• Patients who had been treated with bare-metal stents, drug-eluting stents
• Patients who had successfully undergone follow-up OCT for the target stents >6 months after stenting.

Exclusion Criteria

• The stent was implanted in the left main trunk
• OCT images were of insufficient quality

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kobe University

INDUSTRY

Sponsor Role: lead

Responsible Party

Hiromasa Otake

Division of Cardiovascular Medicine, Department of Internal Medicine, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hiromasa Otake, PhD

Role: STUDY_CHAIR

Kobe University Graduate School of Medicine

Locations

Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, Japan

Countries

Japan

Other Identifiers

KobeU-152M816M

Identifier Type: -

Identifier Source: org_study_id