Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis
- Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces heart function and causes death. Severe aortic stenosis (AS) can be treated in a couple of ways, including replacing a heart valve.
Researchers want to study fibrosis in the heart. A sub-study will test whether heart function and blood supply improve after a valve replacement.
- Adults at least 18 years old with aortic stenosis.
- Participants will visit a clinic for 1 day for magnetic resonance imaging (MRI) of their heart. This uses magnets, radio waves, and computers to produce detailed pictures of the heart.
- After this visit, participants will have their aortic valve procedure at the the Washington Hospital Center. A hospital team will contact participants for 1 year by phone or email. This follow-up will consist of 15 minutes of questions about the participant s health status.
- Some participants will join a sub-study.
- They will be given an additional medication to evaluate the blood supply of the heart.
- They will visit a clinic for 1 day for an MRI of their heart, as part of the main study, prior to the aortic valve replacement.
- After they have their valve replaced at the hospital, they will return to the clinic for another MRI.
- They will have the same follow-up as in the main study.
Aortic Valve Stenosis
|Study Design:||Time Perspective: Prospective|
|Official Title:||Utilization of Cardiac Magnetic Resonance Imaging to Predict Clinical Outcomes of Patients With Severe Aortic Stenosis|
- To assess the ability of cardiac MRI measurement of extracellular volume fraction (related to myocardial fibrosis) to predict short and long term LV function of subjects with severe aortic stenosis undergoing transcatheter AVR. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Aortic valve stenosis is a disease that causes narrowing of a major heart valve, and that reduces heart function and causes death. The purpose of this protocol is to use magnetic resonance imaging of the heart to identify which patients would benefit from replacement of the diseased valve.
|Contact: Marsha Block, R.N.||(301) email@example.com|
|Contact: Andrew E Arai, M.D.||(301) firstname.lastname@example.org|
|United States, District of Columbia|
|Washington Hospital Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|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 email@example.com|
|Principal Investigator:||Andrew E Arai, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|