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New Techniques to Evaluate Mitral Regurgitation

New Techniques to Evaluate Mitral Regurgitation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01063322
Enrollment
50
Registered
2010-02-05
Start date
2010-02-01
Completion date
2018-04-11
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation

Keywords

Mitral Regurgitation, Echocardiography, Cardiac Magnetic Resonance, Regurgitant Volume, Mitral Valve Regurgitation

Brief summary

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.

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.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026