Correlation Between Estimated Glomerular Filtration Rate(eGFR) and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)

• Sponsor: Korea University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02394743
• Collaborator: (none)
• Enrollment: 360
• Location: 1
• Duration (Months): 66.1
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Radiation: 18FDG-PET

Study Design

• Study Type: Observational
• Actual Enrollment: 360 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. absence of prior cancer diagnosis or remission from cancer at the time of PET imaging and throughout the follow-up period;

2. =30 years of age;

3. no prior history of cardiovascular disease ; and

4. absence of acute or chronic inflammatory or autoimmune disease (based on documented medical history) or use of chronic anti-inflammatory therapy.

Exclusion Criteria:

1. age <35 years

2. presence of chronic inflammatory disease

3. use of anti-inflammatory medications

4. 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Internal Medicine, Korea University College of Medicine	Seoul	VD	Korea, Republic of

Sponsors and Collaborators

• Korea University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyung Mook Choi, Medical professor, Korea University
• ClinicalTrials.gov Identifier: NCT02394743
• Other Study ID Numbers: PET_eGRF
• First Posted: Mar 20, 2015
• Last Update Posted: Sep 8, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Kyung Mook Choi, Medical professor, Korea University: Glomerular Filtration Rate
• Additional relevant MeSH terms: Atherosclerosis; Fluorodeoxyglucose F18

Study Results

No Results Posted as of Sep 8, 2016