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New Techniques to Evaluate Mitral Regurgitation

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ClinicalTrials.gov Identifier: NCT01063322
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


- 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

Detailed Description:

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 Design

Study Type : Observational
Actual Enrollment : 50 participants
Time Perspective: Prospective
Official Title: New Techniques to Evaluate Mitral Regurgitation
Study Start Date : February 1, 2010
Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Adult patient, age greater than or equal to 21 years
  • Able to give written informed consent
  • Prior cardiac testing clinically read as having greater than mild MR


  • Atrial fibrillation or other irregular rhythm that would preclude adequate 3D image acquisition
  • History of valve surgery or significant valve disease other than mitral regurgitation
  • Patients with pacemakers, defibrillators, cerebral aneurysm clips, neural stimulators, ear implants or other clinical contra-indications for magnetic resonance scanning will be excluded from the CMR portion of the study
  • Any unstable condition that would make additional imaging time inadvisable (in the opinion of the investigator or managing physician)
  • Pregnant or lactating women
Contacts and Locations

Information from the National Library of Medicine

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
Suburban Hospital
Bethesda, Maryland, United States, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Vandana Sachdev, M.D. National Heart, Lung, and Blood Institute (NHLBI)
More Information

Additional Information:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01063322     History of Changes
Other Study ID Numbers: 100039
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: May 16, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Mitral Regurgitation
Cardiac Magnetic Resonance
Regurgitant Volume
Mitral Valve Regurgitation

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases