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Association Between Framingham Risk Score, hsCRP and Vascular Inflammation: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01139827
First Posted: June 9, 2010
Last Update Posted: June 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Korea University Guro Hospital
  Purpose

Framingham risk score is well known screening tool that detect cardiovascular (CV) risk. But it is not suitable for CV risk in mild risk group. So 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) is a new imaging technique for detecting vascular inflammation within atherosclerotic plaques and hsCRP is also arising detection tool of CV risk.

The investigators are examining this association in normal and impaired glucose tolerance patients groups.


Condition
Cardiovascular Risk

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Further study details as provided by Korea University Guro Hospital:

Enrollment: 178
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
normal
normal group has no diabetes.
IGT
IGT group has impaired fasting glucose or impaired glucose tolerance.

Detailed Description:
We examined vascular inflammation using FDG-PET scan in 178 subjects (Normal and impaired glucose tolerance groups). Vascular 18F-FDG uptake was measured as both the mean and maximum blood-normalized standardized uptake value (SUV), known as the target-to-background ratio (TBR). And We analyzed that the association with Framingham risk score, hs CRP and vascular inflammation by FDG-PET scan.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects underwent routine health checkups at Korea University Guro Hospital. Patients with DM or gestational diabetes were not included.
Criteria

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • a history of cardiovascular disease (myocardial infarction, unstable angina, stroke or cardiovascular revascularization)
  • active inflammatory disease, recent active infection
  • stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
  • diabetes mellitus
  • systemic disorders such as severe hepatic, renal, and hematologic diseases
  • taking drugs known to interfere with vascular inflammation measured by FDG-PET.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139827


Locations
Korea, Republic of
Korea university guro hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea University Guro Hospital
  More Information

ClinicalTrials.gov Identifier: NCT01139827     History of Changes
Other Study ID Numbers: PET(FRS-CRP)
First Submitted: June 8, 2010
First Posted: June 9, 2010
Last Update Posted: June 9, 2010
Last Verified: February 2010

Keywords provided by Korea University Guro Hospital:
atherosclerosis
inflammation
hsCRP
Framingham risk score
positron emission tomography
inflammation in FDG-PET

Additional relevant MeSH terms:
Inflammation
Pathologic Processes