Relation Among HDL Functionality, Neoatherosclerosis and Target Lesion Revascularization

Coronary Artery Disease Progression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540381
• Other study ID #: KobeU-152M816M
• Status: Completed
• Start date: May 1, 2011
• Est. completion date: July 31, 2017

Study information

• Verified date: May 2018
• Source: Kobe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Progression
• Coronary Disease
• Disease Progression
• Erythema Multiforme
• Myocardial Ischemia

Intervention

Other:
• neoatherosclerosis

Locations

Country	Name	City	State
Japan	Kobe University Graduate School of Medicine, Department of Cardiology	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Kobe University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholesterol Uptake Capacity (CUC)	CUC is a new rapid cell-free assay system to evaluate the functional capacity of HDL to accept additional cholesterol	an average of a year and a half