NCT01022684

Brief Summary

Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. Various inflammatory markers such as LpPLA2,MCP-2 and hsCRP are well-known prognostic factors for the cardiovascular event. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between various inflammatory markers and vascular inflammation detected by 18FDG-PET.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

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

First Submitted

Initial submission to the registry

November 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 22, 2010

Status Verified

November 1, 2009

Enrollment Period

1 month

First QC Date

November 27, 2009

Last Update Submit

February 19, 2010

Conditions

Keywords

atherosclerosisvascular inflammationLpPLA2hsCRPMCP-118FDG-PET

Outcome Measures

Primary Outcomes (1)

  • Correlation between various inflammatory markers including LpPLA2,MCP-1 and hsCRP and vascular inflammation analyzed by 18FDG-PET

    12 weeks

Secondary Outcomes (1)

  • Correlation between various inflammatory markers and atherosclerosis measured by carotid intima media thickness

    12 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 between various inflammatory markers and PET imaging at the cross section setting

Healthy patients

Eligibility Criteria

Age20 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy participatin 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)

  • Yang SJ, Kim S, Choi HY, Kim TN, Yoo HJ, Seo JA, Kim SG, Kim NH, Baik SH, Choi DS, Choi KM. High-sensitivity C-reactive protein in the low- and intermediate-Framingham risk score groups: analysis with 18F-fluorodeoxyglucose positron emission tomography. Int J Cardiol. 2013 Mar 10;163(3):277-281. doi: 10.1016/j.ijcard.2011.06.054. Epub 2011 Jun 29.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, 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

Study Record Dates

First Submitted

November 27, 2009

First Posted

December 1, 2009

Study Start

December 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 22, 2010

Record last verified: 2009-11

Locations