Evaluating New Radiation Techniques for Cardiovascular Imaging
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01621594|
Recruitment Status : Recruiting
First Posted : June 18, 2012
Last Update Posted : March 25, 2019
Title: Evaluating New Radiation Techniques for Cardiovascular Imaging
- 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.
- To study new ways of taking pictures of the heart or blood vessels using computed tomography.
- Adults at least 18 years of age who will be having imaging studies to help detect heart or blood vessel problems.
- 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 or disease|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Prospective Evaluation of New Techniques in Radiation Reduction for Cardiovascular Computed Tomographic Angiography|
|Actual Study Start Date :||July 31, 2012|
Subjects with Clinical indication for a coronary CT angiography exam
- Compare time-to-first cardiovascular events (revascularization more than 90 days after CTA, hospitalization, non-fatal myocardial infarction, stroke) in subjects with greater than or equal to 50% coronary stenosis vs. <50% stenosis. [ Time Frame: 5 years ]Thus, the specific aims of this study is to test the diagnostic accuracy of low-radiation dose CT coronary angiography for detecting significant coronary artery stenosis and to determine the prognostic value of low-radiation dose CT coronary angiography for discriminating patient risk of death or major adverse cardiac events.
- Survival analysis of subjects identified by CT with significant coronary artery disease (greater than or equal to 50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis). [ Time Frame: 5 years ]
- Estimate radiation dose from clinically performed cardiovascular CT. [ Time Frame: ongoing ]
- Evaluate image quality from new CT technology. [ Time Frame: ongoing ]
- Estimate diagnostic accuracy of cardiovascular evaluations using new CT technology vs. invasive angiography and versus stress perfusion MRI. [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621594
|Contact: Marsha Block, R.N.||(301) firstname.lastname@example.org|
|Contact: Marcus Y Chen, M.D.||(301) email@example.com|
|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 Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Marcus Y Chen, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|