Evaluating New Radiation Techniques for Cardiovascular Imaging
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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.
- Participants will have follow-up contact 90 days after the scan, and then yearly contact for the next 5 years.
| Condition |
|---|
|
Coronary Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Prospective Evaluation of New Techniques in Radiation Reduction for Cardiovascular Computed Tomographic Angiography |
| Estimated Enrollment: | 1500 |
| Study Start Date: | May 2012 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
- Clinical indication for a coronary CT angiography exam
- Age equal to or greater than 18 years
- Able to understand and willing to sign the Informed Consent Form
- Able and willing to provide follow-up information in 90 days and yearly for up to 5 years
EXCLUSION CRITERIA:
- Pregnancy
- 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 Glomerular filtration rate will be estimated using the MDRD 2005 revised study formula: eGFR (mL/min/1.73m2) = 175 x (standardized serum creatinine)-1.154 x (age)-0.203 x 0.742 (if the subject is female) or x 1.212 (if the subject is black)
Contacts and Locations| Contact: Marsha Block, R.N. | (301) 496-0211 | blockma@mail.nih.gov |
| Contact: Marcus Y Chen, M.D. | (301) 496-0077 | chenmy@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Marcus Y Chen, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT01621594 History of Changes |
| Other Study ID Numbers: | 120141, 12-H-0141 |
| Study First Received: | June 14, 2012 |
| Last Updated: | April 25, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Cardiac Computed Tomography Radiation Reduction Iterative Reconstruction |
Additional relevant MeSH terms:
|
Coronary Disease Coronary Artery Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 19, 2013