NCT02394743

Brief Summary

Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. Renal insufficiency is close correlation with atherosclerosis and cardiovascular mortality. 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 eGFR and vascular inflammation detected by 18F FDG-PET.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 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

March 1, 2011

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

5.5 years

First QC Date

March 16, 2015

Last Update Submit

September 6, 2016

Conditions

Keywords

Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (1)

  • Correlation between vascular inflammatory status measured by 18F FDG-PET and eGFR by Modification of Diet in Renal Disease(MDRD) formula

    at 1 day of taking 18F FDG - PET

Study Arms (3)

eGFR > 90

group whose eGFR is more than 90

Radiation: 18FDG-PET

60 < eGFR <90

group whose eGFR is between 60 and 90

Radiation: 18FDG-PET

eGFR < 60

group whose eGFR is less than 60

Radiation: 18FDG-PET

Interventions

18FDG-PETRADIATION
60 < eGFR <90eGFR < 60eGFR > 90

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who took 18FDG- PET in Korea Guro University

You may qualify if:

  • absence of prior cancer diagnosis or remission from cancer at the time of PET imaging and throughout the follow-up period;
  • \>=30 years of age;
  • no prior history of cardiovascular disease ; and
  • absence of acute or chronic inflammatory or autoimmune disease (based on documented medical history) or use of chronic anti-inflammatory therapy.

You may not qualify if:

  • age \<35 years
  • presence of chronic inflammatory disease
  • use of anti-inflammatory medications
  • presence of active malignant cancer (defined as any radiological or pathological evidence of malignant cancer disease or undergoing chemotherapy or radiation therapy within 1 year before initial PET/CT and throughout the inter-scan duration).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Korea University College of Medicine

Seoul, VD, South Korea

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical professor

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 20, 2015

Study Start

March 1, 2011

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations