New Techniques to Evaluate Mitral Regurgitation

Background:

- 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.

Objectives:

- To evaluate newer methods of studying mitral regurgitation severity using real-time 3D echocardiography (RT3DE) and cardiac magnetic resonance imaging (CMRI).

Eligibility:

- Individuals at least 21 years of age who have been diagnosed with more than mild mitral regurgitation.

Design:

* 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.

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Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA:
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

Exclusion criteria

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

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start: 2010
Study completion: 2018
First posted: Feb 5, 2010
Registry last updated: Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed