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Correlation Between Various Inflammatory Markers and Vascular Inflammation Measured by 18FDG-PET

This study has been completed.
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT01022684
First received: November 27, 2009
Last updated: February 19, 2010
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Atherosclerosis
 Other: Cross section study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Correlation of Inflammatory Markers Such as LpPLA2,MCP-1 and hsCRP for Predicting Vascular Inflammation; Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Further study details as provided by Korea University:

Primary Outcome Measures:
  • Correlation between various inflammatory markers including LpPLA2,MCP-1 and hsCRP and vascular inflammation analyzed by 18FDG-PET [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between various inflammatory markers and atherosclerosis measured by carotid intima media thickness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood, serum


Enrollment: 150
Study Start Date: December 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy patients 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

  Eligibility

Ages Eligible for Study:   20 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022684

Locations
Korea, Republic of
Hye Jin Yoo
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Kyung Mook Choi, MD.PhD Korea University
  More Information

No publications provided by Korea University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kyung Mook Choi, Korea University
ClinicalTrials.gov Identifier: NCT01022684     History of Changes
Other Study ID Numbers: KOSEF20546
Study First Received: November 27, 2009
Last Updated: February 19, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University:
atherosclerosis
vascular inflammation
LpPLA2
 hsCRP
MCP-1
18FDG-PET

Additional relevant MeSH terms:
Atherosclerosis
Inflammation
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013