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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01022684
Other study ID # KOSEF20546
Secondary ID
Status Completed
Phase N/A
First received November 27, 2009
Last updated February 19, 2010
Start date December 2009
Est. completion date January 2010

Study information

Verified date November 2009
Source Korea University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 88 Years
Eligibility Inclusion Criteria:

- Healthy patients for visiting routine medical check in our clinic

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
Cross section study
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

Locations

Country Name City State
Korea, Republic of Hye Jin Yoo Seoul

Sponsors (1)

Lead Sponsor Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between various inflammatory markers including LpPLA2,MCP-1 and hsCRP and vascular inflammation analyzed by 18FDG-PET 12 weeks No
Secondary Correlation between various inflammatory markers and atherosclerosis measured by carotid intima media thickness 12 weeks No
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