NCT04652973

Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 118 (actual)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Evaluation of Atherosclerotic Plaques in Prostate Cancer Patients. Study Description: This study measures atherosclerotic plaques in the vessels of prostate cancer patients in contrast-enhanced computed tomography (CECT), then finds correlation between the plaque and clinical biomarkers. These biomarkers include laboratory tests, pathologic findings, underlying risk factors, demographic information, and outcomes of the patient. Objectives: Primary objective: Measure atherosclerotic plaques on contrast-enhanced computed tomography (CECT). Secondary objective: Find correlation between plaque measurement and clinical biomarkers of prostate cancer patients. Study Population: Up to 1,000 NIH Clinical Center patients. Description of Sites/Facilities conducting research: NIH Clinical Center Study Duration: 10 years

Conditions

• Prostatic Neoplasms

Timeline

• Start date: 2020-11-19
• Primary completion: 2030-08-30
• Completion: 2030-08-30
• First posted: 2020-12-04
• Last updated: 2025-08-29

Locations

1 site across 1 country: United States