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Protocol Details

Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000123-CC

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 30 Years
Max Age: 90 Years

Referral Letter Required

Yes

Population Exclusion(s)

Children;
Neonates;
Pregnant Women;
Fetuses

Keywords

CT measurement;
CVD;
CT coronary angiogram;
clinical biomarkers;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Prostatic Neoplasms

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

Background:

Fat and calcium can build up as plaque in artery walls. The Agatston score measures plaque using computed tomography (CT) that does not use an injected contrast agent. Plaque in the arteries of the pelvis and abdomen is linked to cardiovascular disease (CVD) risk factors. It also may affect cancer. But abdominal CTs use a contrast agent (CECT). Therefore, the Agatston score cannot be used. Researchers want to find a way to measure plaque in CECTs. This will help them use abdominal CTs to measure plaque without extra radiation.

Objective:

To measure atherosclerotic plaques on CECT in a group of males.

Eligibility:

Men ages 30-90 with prostate cancer (proven with biopsies) who have abdomen CT studies in the PACS (picture archiving system) in the Clinical Center. Also, men or women of all ages who have multiphase abdomen and pelvic CT studies that are in the PACS.

Design:

This study will use data gathered since 1/1/2013. Data will also be taken from protocol 03-CC-0128 and clinical trials 15-C-0124, 16-C-0048, 14-C-0112, and 04-C-0274. Participants from these studies have allowed their samples to be used in the future.

Participants will be found via keyword searches on NIH databases. Their CT and MRI scans will be used. Data such as age, race, disease, and treatment will be used. Results of other tests may be used.

The plaque in participants abdomen and iliac arteries will be measured. It will be compared with biomarkers related to CVD and prostate cancer, such as weight, age, and race.

This study will take place at one site. Data will be stored on secure computers. Printouts will be kept in locked rooms.

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Eligibility

INCLUSION CRITERIA:

The study will use existing radiologic data.

EXCLUSION CRITERIA:

NONE


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Ronald M. Summers, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 1C224D
10 CENTER DR
BETHESDA MD 20892
(301) 402-5486
rsummers@mail.cc.nih.gov

Pritam Mukherjee
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1C224
10 Center Drive
Bethesda, Maryland 20892
(301) 402-5486
pritam.mukherjee@nih.gov

Sungwon Lee
BG 10 RM 1C224
10 CENTER DR
BETHESDA MD 20814
(301) 827-9481
sungwon.lee@nih.gov

Clinical Trials Number:

NCT04652973

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