Protocol Number: 09-H-0166

Title:

Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation

Number:

09-H-0166

Summary:

Background:

- To evaluate the outcomes of mitral valve repair or replacement in patients with severe mitral valve leakage (regurgitation), researchers at the National Institutes of Health (NIH) will perform various tests to measure heart function before and after surgery.

Objectives:

- To record the results of echocardiograms and cardiopulmonary exercise testing in patients who are scheduled to have corrective surgery for severe mitral valve regurgitation.

Eligibility:

- Patients 18 years of age and older who are scheduled to undergo surgery to repair or replace a defective mitral valve.

Design:

- Patients will come to NIH before the planned surgery to have an echocardiogram and cardiopulmonary exercise test on an outpatient basis.

- Cardiopulmonary exercise testing: Patients will be asked to exercise on a treadmill while wearing a face mask to measure heart rhythm, oxygen use rates, and blood pressure. The entire test will take approximately 1 hour.

- Echocardiography: Researchers will use ultrasound waves to take pictures of the heart. A complete baseline examination will be performed by a sonographer and evaluated by a physician. Patients may receive a small amount of an approved contrast agent (drug) to improve picture quality. The entire test will take approximately 1 hour.

- Patients will return to NIH at 6, 12, and 24 months after surgery to repeat the tests.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

ELIGIBILITY CRITERIA:

The patient population for this trial consists of patients with severe ischemic mitral regurgitation with and without the need for concomitant coronary artery bypass surgery. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity. All patients enrolled in the treatment study will undergo preoperative echocardiogram and cardiopulmonary stress testing at the NIH Clinical Center through the current protocol. For patients who are unable to come to the Clinical Center for medical reasons (determined by any of the investigators), the echocardiograms will be performed at Suburban Hospital. Location of the study will be arranged with the Suburban Echo Lab and the patient's clinical providers.

The Inclusion Criteria for the CTSN protocol have been modified to use an integrative method to assess mitral regurgitation as specified below and on page 14 of the CT5N protocol.

-Chronic severe ischemic mitral regurgitation (often with tethering as a major mechanism) in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. Assessment of mitral regurgitation will be performed

using an integrative method (Zoghbi W. et al. J. American Society of Echocardiography. 2003;16;777-802). Quantitative guidelines as proposed would be; ERO greater than or equal to 0.4 cmsq. If ERO less than 0.4, then the degree of mitral regurgitation will be guided by other color Doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive criteria in an integrated fashion.

Special Instructions:

Currently Not Provided

Keywords:

Ischemic Mitral Regurgitation

Cardiopulmonary Bypass

Coronary Artery Bypass Grafting

Left Ventricular Remodeling

Coronary Artery Disease

Recruitment Keyword(s):

Coronary Artery Disease

Condition(s):

Mitral Regurgitation

Coronary Artery Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Procedure/Surgery: CABG

Procedure/Surgery: MVR

Supporting Site:

National Heart, Lung, and Blood Institute

Contact(s):

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

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Borger MA, Alam A, Murphy PM, Doenst T, David TE. Chronic ischemic mitral regurgitation: repair, replace or rethink? Ann Thorac Surg. 2006 Mar;81(3):1153-61.

Lamas GA, Mitchell GF, Flaker GC, Smith SC Jr, Gersh BJ, Basta L, Moyˇ L, Braunwald E, Pfeffer MA. Clinical significance of mitral regurgitation after acute myocardial infarction. Survival and Ventricular Enlargement Investigators. Circulation. 1997 Aug 5;96(3):827-33.

Hickey MS, Smith LR, Muhlbaier LH, Harrell FE Jr, Reves JG, Hinohara T, Califf RM, Pryor DB, Rankin JS. Current prognosis of ischemic mitral regurgitation. Implications for future management. Circulation. 1988 Sep;78(3 Pt 2):I51-9.

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