NCT03540381

Relation Among HDL Functionality, Neoatherosclerosis and Target Lesion Revascularization

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 181 (actual)
• Sponsor: Kobe University · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	neoatherosclerosis

Timeline

• Start date: 2011-05-01
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2018-05-30
• Last updated: 2018-05-30

Locations

1 site across 1 country: Japan