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NCT Number: NCT03540381

Relation Among HDL Functionality, Neoatherosclerosis and Target Lesion Revascularization

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

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, 650-0017, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

neoatherosclerosis

Other

Primary outcomes

  1. Cholesterol Uptake Capacity (CUC)

    Time frame: an average of a year and a half

    CUC is a new rapid cell-free assay system to evaluate the functional capacity of HDL to accept additional cholesterol

Sponsors and collaborators

Lead sponsor

Kobe University

Industry

Registry information

Official study title

Relation Among Cholesterol Uptake Capacity Which Measure HDL Functionality, Neoatherosclerosis and Target Lesion Revascularization After Stent Implantation

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
May 30, 2018
Registry last updated
May 30, 2018

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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