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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00838786 |
The research activities in this protocol are meant to support the multicenter CSTN (Cardiothoracic Surgical Trials Network) protocol, Surgical Interventions for Moderate Ischemic Mitral Regurgitation which is being conducted at Suburban Hospital. This protocol deals with only the research studies being conducted at the NIH Clinical Center. Patients undergoing surgery at the NIH Heart Center at Suburban Hospital will be recruited for this study. The Principal Investigator there is Dr. Keith Horvath and the majority of procedures will be performed at Suburban Hospital and monitored by the Suburban Hospital Institutional Review Board (IRB). The preoperative and follow-up echo and cardiopulmonary stress tests on enrolled patients, however, will be performed at the NIH Clinical Center and will be described in detail by this protocol. In addition, to ensure consistency of data quality, NIH staff will be assisting with the acquisition of the intro-operative echo studies at Suburban Hospital.
The overall objective of this study is to evaluate the safety and efficacy of mitral valve repair (MVR) for moderate ischemic mitral regurgitation.
Specifically, this study compares mitral valve repair combined with coronary artery bypass grafting (CABG) to coronary artery bypass grafting alone in this patient population. Patients will be randomly assigned (1:1) to CABG + MVR or CABG alone.
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Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease Mitral Regurgitation |
Procedure: CABG Procedure: MVR |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Surgical Interventions for Moderate Ischemic Mitral Regurgitation |
Estimated Enrollment: | 10 |
Study Start Date: | January 2009 |
The research activities in this protocol are meant to support the multicenter CSTN (Cardiothoracic Surgical Trials Network) protocol, Surgical Interventions for Moderate Ischemic Mitral Regurgitation which is being conducted at Suburban Hospital. This protocol deals with only the research studies being conducted at the NIH Clinical Center. Patients undergoing surgery at the NIH Heart Center at Suburban Hospital will be recruited for this study. The Principal Investigator there is Dr. Keith Horvath and the majority of procedures will be performed at Suburban Hospital and monitored by the Suburban Hospital Institutional Review Board (IRB). The preoperative and follow-up echo and cardiopulmonary stress tests on enrolled patients, however, will be performed at the NIH Clinical Center and will be described in detail by this protocol. In addition, to ensure consistency of data quality, NIH staff will be assisting with the acquisition of the intro-operative echo studies at Suburban Hospital.
The overall objective of this study is to evaluate the safety and efficacy of mitral valve repair (MVR) for moderate ischemic mitral regurgitation.
Specifically, this study compares mitral valve repair combined with coronary artery bypass grafting (CABG) to coronary artery bypass grafting alone in this patient population. Patients will be randomly assigned (1:1) to CABG + MVR or CABG alone.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
The patient population for this trial consists of adult patients with moderate ischemic mitral regurgitation and clinically significant coronary artery disease with a clinical indication for coronary artery bypass grafting (CABG). 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.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Suburban Hospital | Recruiting |
Bethesda, Maryland, United States, 20814 |
Study ID Numbers: | 090050, 09-H-0050 |
Study First Received: | February 5, 2009 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00838786 History of Changes |
Health Authority: | United States: Federal Government |
Ischemic Mitral Regurgitation Coronary Artery Disease Coronary Artery Bypass Grafting Left Ventricular Remodeling |
Coronary Artery Disease Coronary Artery Bypass Grafting Mitral Valve |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Arteriosclerosis Ischemia Coronary Artery Disease Heart Valve Diseases Mitral Valve Insufficiency |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease Heart Valve Diseases Mitral Valve Insufficiency |