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Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Korea University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT01100671
First received: April 8, 2010
Last updated: June 23, 2011
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Atherosclerosis
 Other: Cross section study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation in Healthy Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korea University:

Primary Outcome Measures:
  • Correlation between vascular inflammatory status measured by 18FDG PET and MDCT [ Time Frame: 20weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison the correlation with inflammatory marker and vascular inflammatory status assessed by 18FDG PET and MDCT [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

plasam and serum


Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (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 of vascular inflammation assessed by 18FDG-PET and MDCT at the cross section setting

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy participants 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: NCT01100671

Contacts
Contact: Hye Jin Yoo, MD 82-2-2626-3045 deisy21@medimail.co.kr

Locations
Korea, Republic of
Hye Jin Yoo Recruiting
Seoul, Korea, Republic of
Contact: Hye Jin Yoo, MD.PhD     82226263045     deisy21@medimail.co.kr    
Contact: Kyung Mook Choi, MD.PhD     82226263043     medica7@gmail.com    
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Kyung Mook Choi, MD.PhD Korea University
  More Information

No publications provided

Responsible Party: Kyung Mook Choi, Korea University
ClinicalTrials.gov Identifier: NCT01100671     History of Changes
Other Study ID Numbers: PET_Coronary CT
Study First Received: April 8, 2010
Last Updated: June 23, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University:
atherosclerosis
vascular inflammation
MDCT
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 16, 2013