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Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04652973
Enrollment
118
Registered
2020-12-04
Start date
2020-11-19
Completion date
2030-08-30
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

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

Brief 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

Interventions

None listed

Sponsors

National Institutes of Health Clinical Center (CC)
Lead SponsorNIH

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* INCLUSION CRITERIA: The study will use existing radiologic data.

Exclusion criteria

NONE

Design outcomes

Primary

MeasureTime frameDescription
1/Measure atherosclerotic plaquesEnd of studyMeasure atherosclerotic plaques on contrast-enhanced computed tomography (CECT)

Secondary

MeasureTime frameDescription
2/Plaque measurement and clinical biomarkers correlationEnd of studyFind correlation between plaque measurement and clinical biomarkers of prostate cancer patients.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026