Skip to main content
Clinical Trials/NCT03540381
NCT03540381
Completed
Not Applicable

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

Kobe University1 site in 1 country181 target enrollmentMay 1, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease Progression
Sponsor
Kobe University
Enrollment
181
Locations
1
Primary Endpoint
Cholesterol Uptake Capacity (CUC)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2011
End Date
July 31, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hiromasa Otake

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

Kobe University

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

Outcomes

Primary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials