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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyung Mook Choi, Korea University
ClinicalTrials.gov Identifier:
NCT01100671
First received: April 8, 2010
Last updated: October 12, 2015
Last verified: March 2010
  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:


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

Enrollment: 120
Study Start Date: April 2010
Study Completion Date: August 2011
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100671

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyung Mook Choi, Professor, Korea University
ClinicalTrials.gov Identifier: NCT01100671     History of Changes
Other Study ID Numbers: PET_Coronary CT 
Study First Received: April 8, 2010
Last Updated: October 12, 2015
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University:
atherosclerosis
vascular inflammation
MDCT
18FDG-PET

Additional relevant MeSH terms:
Inflammation
Atherosclerosis
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Deoxyglucose
Fluorodeoxyglucose F18
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Radiopharmaceuticals

ClinicalTrials.gov processed this record on August 28, 2016