NCT01150006

Brief Summary

The inflammatory state and composition of atherosclerotic plaques are considered the main contributing factors responsible for acute cardiovascular events, rather than the degree of stenosis. Recently, positron emission tomography (PET) with 18F-fluoro-deoxyglucose (FDG) has been suggested as a promising novel imaging technique to identify the inflammatory state of atherosclerotic plaque. Recently, a few clinical studies showed that circulating A-FABP level had a close relation with the development of atherosclerosis in human. Therefore, in the present study, the investigators examined the relationship between circulating A-FABP and vascular inflammation of carotid arteries measured using FDG-PET in healthy male subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 24, 2010

Completed
Last Updated

June 29, 2010

Status Verified

April 1, 2010

Enrollment Period

2 months

First QC Date

June 9, 2010

Last Update Submit

June 28, 2010

Conditions

Keywords

atherosclerosisvascular inflammationadipocyte fatty acid binding proteinadiponectinleptin18FDG-PET

Outcome Measures

Primary Outcomes (1)

  • Vascular inflammation in carotid arterial wall, represented as the target-to-background ratio (TBR), using FDG-PET

    12 weeks

Secondary Outcomes (4)

  • Circulating serum A-FABP levels

    12 weeks

  • Circulating serum leptin levels

    12weeks

  • Circulating serum adiponectin levels

    12 weeks

  • Carotid intima-media thickness levels measured using ultrasonography

    12 weeks

Study Arms (1)

Healthy male participants

Other: Cross sectional study

Interventions

This is not intervention study. The purpose of the study is to examine the relationship between various adipokine levels and PET imaging at the cross section setting

Healthy male participants

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy male participats who underwent a medical health check in the health promotion center in Korea Guro University

You may qualify if:

  • Healthy male volunteers for visiting routine medical check in our clinic

You may not qualify if:

  • History of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization)
  • Diabetes
  • Hypertension
  • Malignancy
  • Severe renal or hepatic disease
  • Subjects taking medications that might affect inflammation such as NSIAD and statin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hye Jin Yoo

Seoul, 152-703, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, plasma, serum

MeSH Terms

Conditions

Atherosclerosis

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kyung Mook Choi, MD.PhD

    Korea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 24, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 29, 2010

Record last verified: 2010-04

Locations