New Techniques to Evaluate Mitral Regurgitation
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01063322|
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : July 12, 2018
- Mitral regurgitation, or leaking of the mitral heart valve, is usually studied and assessed with an ultrasound test called a two-dimensional (2D) echocardiogram. While this test has proved very useful, technological improvements have helped researchers develop ways to study the heart valves using imaging with three-dimensional (3D) capabilities. In addition, recently developed magnetic resonance imaging (MRI) techniques may be able to provide better information about the causes and severity of the leak. Researchers are interested in testing these new techniques to determine their usefulness for patients with mitral regurgitation.
- To evaluate newer methods of studying mitral regurgitation severity using real-time 3D echocardiography (RT3DE) and cardiac magnetic resonance imaging (CMRI).
- Individuals at least 21 years of age who have been diagnosed with more than mild mitral regurgitation.
- Participants will have two procedures as part of this study: an echocardiogram and an MRI scan.
- For the echocardiogram, participants will have an ultrasound scan with a special kind of probe. Participants may also receive an injection of a contrast agent to provide a better image of the heart on the scan. The scan will take approximately 1 hour to complete.
- For the MRI scan, participants will have a standard MRI with special pads placed on the chest to provide better imaging of the heart. The scan will usually take between 45 and 90 minutes to complete.
|Condition or disease|
|Mitral Valve Regurgitation|
Echocardiography is currently the technique of choice to assess the etiology and severity of mitral regurgitation (MR). Multiple 2D and Doppler parameters are assessed in an integrated fashion and the proximal flow convergent zone of the mitral regurgitation jet is used to calculate effective regurgitant orifice area and regurgitant volume. These measurements have been shown to have important prognostic information. In the last two years, the development of transesophageal imaging with 3D capability has allowed a better visualization of mitral leaflet pathology. Color Doppler 3D studies have shown that 2D methods generally underestimate mitral regurgitant volume. Magnetic resonance techniques have recently been developed to quantitate flow and calculate regurgitant volumes.
The purpose of this study is to evaluate newer methods of quantitating mitral regurgitation severity using real-time 3D echocardiography (RT3DE) and cardiac magnetic resonance imaging (CMR). Although RT3DE measurements have been shown to correlate well with CMR measures of LV volumes, using a 3D volumetric method to calculate mitral regurgitant volumes has not been well studied. In patients with more than mild mitral regurgitation, we will obtain transthoracic RT3DE measures of mitral regurgitant volume and compare them with traditional 2D measures of MR severity. We will also compare RT3DE and CMR measures of mitral regurgitant volume.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||New Techniques to Evaluate Mitral Regurgitation|
|Study Start Date :||February 1, 2010|
|Study Completion Date :||April 11, 2018|
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): NCT01063322
|United States, Maryland|
|Bethesda, Maryland, United States, 20814|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Vandana Sachdev, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|