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Protocol Details

New Techniques to Evaluate Mitral Regurgitation

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-H-0039

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 21
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Mitral Regurgitation;
Echocardiography;
Cardiac Magnetic Resonance;
Regurgitant Volume

Recruitment Keyword(s)

Mitral Valve Regurgitation

Condition(s)

Mitral Valve Regurgitation

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood Institute

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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Eligibility

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


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Citations:

Sheikh K, Smith SW, von Ramm O, Kisslo J. Real-time, three-dimensional echocardiography: feasibility and initial use. Echocardiography. 1991 Jan;8(1):119-25.

Schmidt MA, Ohazama CJ, Agyeman KO, Freidlin RZ, Jones M, Laurienzo JM, Brenneman CL, Arai AE, von Ramm OT, Panza JA. Real-time three-dimensional echocardiography for measurement of left ventricular volumes. Am J Cardiol. 1999 Dec 15;84(12):1434-9.

Jacobs LD, Salgo IS, Goonewardena S, Weinert L, Coon P, Bardo D, Gerard O, Allain P, Zamorano JL, de Isla LP, Mor-Avi V, Lang RM. Rapid online quantification of left ventricular volume from real-time three-dimensional echocardiographic data. Eur Heart J. 2006 Feb;27(4):460-8. Epub 2005 Nov 30.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Vandana Sachdev, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10-CRC RM 5-1436
10 CENTER DR
BETHESDA MD 20814
(301) 496-3015
vs74y@nih.gov

Cynthia L. Brenneman, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 5-1436
10 Center Drive
Bethesda, Maryland 20892
(301) 451-3799
brennemc@nhlbi.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01063322

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