Relation Among HDL Functionality, Neoatherosclerosis and Target Lesion Revascularization

NCT03540381 | Completed DMC

• 1 other identifier: KobeU-152M816M
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease Progression

Keywords

Neoatherosclerosis; Cholesterol Uptake Capacity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

neoatherosclerosis OTHER

Identified neoatherosclerosis group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• The stent was implanted in the left main trunk
• OCT images were of insufficient quality

Sponsors & Collaborators

• Kobe University: lead

Study Sites (1)

Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, 650-0017, Japan

Location

Study Officials

• Hiromasa Otake, PhD

  Kobe University Graduate School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Cardiovascular Medicine, Department of Internal Medicine, Assistant Professor

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 30, 2018
• Study Start: May 1, 2011
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

JP (1)