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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease Progression
• Intervention / Treatment: Other: neoatherosclerosis

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.

• Study Type: Observational
• Enrollment (Actual): 181

Contacts and Locations

Study Locations

• Japan
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0017
      • Kobe University Graduate School of Medicine, Department of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study population consist of the consecutive patients who have undergone coronary-artery OCT. the investigators performed OCT for these reasons: (1) planned follow-up coronary angiography and OCT as routine stent follow-up or due to other study protocols, regardless of symptoms; (2) evidence of myocardial ischemia, such as silent myocardial ischemia, stable angina, or acute coronary syndrome; or (3) planned follow-up angiography for other stent segments. Exclusion criteria for OCT were (1) anatomically unsuitable target artery for OCT, according to previously described criteria; (2) apparent congestive heart failure; (3) renal insufficiency with baseline creatinine level of ≥2.0 mg/dL except for under hemodialysis; or (4) no written informed consent from the patient.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: neoatherosclerosis
Not-identified neoatherosclerosis group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kobe University
• Investigators: Study Chair: Hiromasa Otake, PhD, Kobe University Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Neoatherosclerosis; Cholesterol Uptake Capacity
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Coronary Disease; Erythema; Skin Diseases, Vesiculobullous; Coronary Artery Disease; Disease Progression; Erythema Multiforme
• Other Study ID Numbers: KobeU-152M816M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No