NCT01139827

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
Last Updated

June 9, 2010

Status Verified

February 1, 2010

Enrollment Period

5 months

First QC Date

June 8, 2010

Last Update Submit

June 8, 2010

Conditions

Keywords

atherosclerosisinflammationhsCRPFramingham risk scorepositron emission tomographyinflammation in FDG-PET

Study Arms (2)

normal

normal group has no diabetes.

IGT

IGT group has impaired fasting glucose or impaired glucose tolerance.

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subjects underwent routine health checkups at Korea University Guro Hospital. Patients with DM or gestational diabetes were not included.

You may qualify if:

  • healthy subjects

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea university guro hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

AtherosclerosisInflammation

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 9, 2010

Study Start

September 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

June 9, 2010

Record last verified: 2010-02

Locations