New Techniques to Evaluate Mitral Regurgitation

NCT01063322 | Completed

• 2 other identifiers: 10003910-H-0039
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Mitral Valve Regurgitation

Keywords

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (2)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1111/j.1540-8175.1991.tb01409.x.

  PMID: 10149247 BACKGROUND

• 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. doi: 10.1016/s0002-9149(99)00591-3.

  PMID: 10606118 BACKGROUND

• 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. doi: 10.1093/eurheartj/ehi666. Epub 2005 Nov 30.

  PMID: 16319085 BACKGROUND

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Vandana Sachdev, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: February 1, 2010
• Study Completion: April 11, 2018
• Last Updated: December 17, 2019

Record last verified: 2018-04-11

Locations

US (2)