NCT01100671

Brief Summary

Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.cardiac multidetector-row CT can provide measurements of coronary artery calcium (CAC), the degree of stenosis, and the characteristics of plaque including its potential vulnerability. Therefore, the purpose of the investigators study is to compare the usefulness of 18 FDG-PET and MDCT in assessing the vascular inflammatory status and vulnerability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

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
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

April 8, 2010

Last Update Submit

March 12, 2018

Conditions

Keywords

atherosclerosisvascular inflammationMDCT18FDG-PET

Outcome Measures

Primary Outcomes (1)

  • Correlation between vascular inflammatory status measured by 18FDG PET and MDCT

    20weeks

Secondary Outcomes (1)

  • Comparison the correlation with inflammatory marker and vascular inflammatory status assessed by 18FDG PET and MDCT

    20 weeks

Study Arms (1)

Healthy patients

Other: Cross section study

Interventions

This is not intervention study. The purpose of the study is to examine the relationship of vascular inflammation assessed by 18FDG-PET and MDCT at the cross section setting

Healthy patients

Eligibility Criteria

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

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

You may qualify if:

  • Healthy patients 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
  • Stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
  • 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, South Korea

Location

Related Publications (1)

  • Yoo HJ, Yong HS, Hwang SY, Eo JS, Hong HC, Seo JA, Kim SG, Kim NH, Choi DS, Baik SH, Choi KM. Association of pooled cohort risk scores with vascular inflammation and coronary artery calcification in Korean adults. Metabolism. 2016 Mar;65(3):1-7. doi: 10.1016/j.metabol.2015.10.016. Epub 2015 Oct 22.

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasam and serum

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kyung Mook Choi, MD.PhD

    Korea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 9, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations