Evaluating New Radiation Techniques for Cardiovascular Imaging
Purpose
Title: Evaluating New Radiation Techniques for Cardiovascular Imaging Background: - Imaging studies such as computed tomography (CT) scans involve the use of radiation to create the pictures. Heart and blood vessel CT scans can cause high radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose. Researchers want to see how effective these new methods are in producing accurate CT scans. Objectives: - To study new ways of taking pictures of the heart or blood vessels using computed tomography. Eligibility: - Adults at least 18 years of age who will be having imaging studies to help detect heart or blood vessel problems. Design: - Participants will be screened with a physical exam and medical history. Blood samples will be taken to check kidney function. - Participants will have a CT scan of the heart and blood vessels. A contrast agent may be used to improve the quality of the images. The scanning session may last up to 2 hours. - Timing of and the need for follow up contact will depend on results from the initial scan and may be repeated to assess for late events. Telephone, office contact, or other follow-up of subjects may be done after CCTA to evaluate if the subject had subsequent cardiovascular testing. Further follow up will be based on reported test results.
Condition
- Coronary Disease
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Clinical indication for a coronary CT angiography exam 2. Age equal to or greater than 18 years 3. Able to understand and willing to sign the Informed Consent Form 4. Able and willing to provide follow-up information
Exclusion Criteria
- Pregnancy 2. If receiving intravenous contrast, severe renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria or as reported by the clinical lab. Glomerular filtration rate will be estimated using the 2021 CK-EPI equation that eliminate the use of race coefficient as reported in CRIS. Screen Failures: Subjects who are screen failures can be re-enrolled once they meet eligibility criteria. Rescreened participants will be assigned the same participant number as for the initial screening.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 1 |
Subjects with Clinical indication for a coronary CT angiography exam |
|
Recruiting Locations
Bethesda, Maryland 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
800-411-1222
ccopr@nih.gov
More Details
- NCT ID
- NCT01621594
- Status
- Recruiting
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Detailed Description
Cardiac CT angiography is associated with radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose to the subject. The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.