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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Collaborators: |
Canadian Institutes of Health Research (CIHR) National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by (Responsible Party): | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00806988 |
Purpose
Coronary artery bypass grafting (CABG) is a procedure that people with coronary artery disease (CAD) may undergo to increase blood flow to the heart. During a CABG procedure, people who have a leak in one of the valves in the heart—the mitral valve—may at the same time undergo a procedure that repairs the valve. This study will evaluate whether people with moderate mitral valve leakage would be better off undergoing CABG plus the mitral valve repair procedure or undergoing CABG alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Mitral Valve Insufficiency Coronary Artery Disease |
Procedure: Mitral Valve Repair Procedure: CABG |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Surgical Interventions for Moderate Ischemic Mitral Regurgitation |
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will undergo CABG and a mitral valve repair procedure.
|
Procedure: Mitral Valve Repair
Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:
CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
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|
Active Comparator: 2
Participants will undergo CABG.
|
Procedure: CABG
CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator.
|
CAD occurs when the arteries that supply blood to the heart become blocked as a result of plaque buildup. In severe cases, CAD can cause chest pain, shortness of breath, and heart attack. CABG is one treatment option for people with CAD. During a CABG procedure, a healthy artery or vein from another part of the body is connected to the blocked coronary artery. Blood flow is then routed around the blockage to the heart.
After a heart attack, some people may have a leak in the mitral valve of the heart. This condition is known as ischemic mitral regurgitation (IMR) and is associated with poor health outcomes, including worsening heart failure. In people with severe mitral valve leakage, the CABG procedure and a mitral valve repair procedure are routinely performed together; however, in people with only moderate valve leakage, there is no consensus in the medical community as to whether the mitral valve repair procedure is beneficial at the time of CABG. The purpose of this study is to determine whether people with moderate mitral valve regurgitation should undergo a mitral valve repair procedure in addition to CABG or undergo CABG alone.
This study will enroll people with CAD who require a CABG procedure and have moderate mitral regurgitation. At a baseline study visit, participants will undergo a physical examination; blood collection; neurocognitive tests; and questionnaires regarding medical history, medication history, and quality of life. In the operating room, participants will be randomly assigned to undergo either CABG surgery and the mitral valve repair procedure or only CABG surgery. Blood, urine, and tissue samples may be collected from participants after the surgery; this is optional and will only be done with prior approval from participants. All participants will attend study visits at Months 6, 12, and 24. At each visit, participants will take part in a medication history review, a physical examination, an echocardiogram, a cardiopulmonary exercise test, neurocognitive tests, and quality of life surveys.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Annetine Gelijns, PhD | 212-659-9568 | annetine.gelijns@mssm.edu |
| Contact: Ellen Moquete, RN, BSN | 212-659-9651 | ellen.moquete@mountsinai.org |
| United States, California | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Michael Bowdish, MD 323-442-5849 michael.bowdish@med.usc.edu | |
| Contact: Shadi Javadifar 323-442-6252 shadi.javadifar@med.usc.edu | |
| Principal Investigator: Michael Bowdish, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30383 | |
| Contact: John Puskas, MD 404-686-2513 john_puskas@emoryhealthcare.org | |
| Contact: Alexis Neill, RN 404-686-3575 alexis.neill@emoryhealthcare.org | |
| Principal Investigator: John Puskas, MD | |
| Wellstar Kennestone Hospital | Recruiting |
| Marietta, Georgia, United States, 30060 | |
| Contact: William A Cooper, MD 404-686-2513 William.cooper@emoryhealthcare.org | |
| Contact: Jennifer LaCorte, RN 770-793-5975 jennifer.lacorte@wellstar.org | |
| Principal Investigator: William A Cooper, MD | |
| United States, Maryland | |
| University of Maryland | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: James Gammie, MD 410-328-5842 jgammie@smail.umaryland.edu | |
| Contact: Dana Beach, BSN, RN 410-328-0993 dbeach2@smail.umaryland.edu | |
| Principal Investigator: James S Gammie, MD | |
| NIH Heart Center at Suburban Hospital | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Keith Horvath, MD 301-451-7098 khorvath@nih.gov | |
| Contact: Mandy Murphy, RN 301-896-3775 mmurphy@suburbanhospital.org | |
| Principal Investigator: Keith Horvath, MD | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Frederick Y Chen, MD 617-732-7775 fchen@partners.org | |
| Contact: Debra Conboy, RN 617-732-7019 daconboy@partners.org | |
| Principal Investigator: Frederick Y Chen, MD, PhD | |
| United States, Missouri | |
| Washington University | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| Contact: Ralph J Damiano, MD 314-362-7327 damianor@wudosis.wustl.edu | |
| Contact: Tracey Guthrie, RN 314-747-4404 guthriet@wudosis.wustl.edu | |
| Principal Investigator: Ralph J Damiano, MD | |
| United States, New York | |
| Montefiore Einstein Heart Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Robert E. Michler, MD 718-920-2100 rmichler@montefiore.org | |
| Contact: Roger Swayze, RN 718-920-2221 rswayze@montefiore.org | |
| Principal Investigator: Robert E. Michler, MD | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Michael Argenziano, MD 212-305-5888 ma66@columbia.edu | |
| Contact: Lyn Goldsmith, MA, RN, CCRC 212 342 0261 lg2240@columbia.edu | |
| Principal Investigator: Michael Argenziano, MD | |
| United States, North Carolina | |
| Mission Hospital | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Mark Groh, MD 828-258-1121 mgroh@ashevilleheart.com | |
| Contact: Claudine Cuento, BSN, RN 828-213-7032 claudine.cuento@msj.org | |
| Principal Investigator: Mark A Groh, MD | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Peter Smith, MD 919-684-2890 smith058@mc.duke.edu | |
| Contact: Stacey Welsh, RN stacey.welsh@duke.edu | |
| Principal Investigator: Peter Smith, MD | |
| East Carolina Heart Institute | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Contact: T. Bruce Ferguson, MD 252-744-5232 Fergusont@ecu.edu | |
| Contact: Malissa Harris, RN 252-744-5287 Harrismal@ecu.edu | |
| Principal Investigator: T. Bruce Ferguson, MD | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Eugene Blackstone, MD 216-444-6712 blackse@ccf.org | |
| Contact: Christine Whitman, RN, CCRC 216-445-6916 whitmac@ccf.org | |
| Principal Investigator: Eugene Blackstone, MD | |
| Sub-Investigator: Mark Gillinov, MD | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Chittoor B Sai-Sudhakar, MBBS 614-293-9327 sai.sudhakar@osumc.edu | |
| Contact: Danielle Jones, RN 614-366-8506 danielle.jones@osumc.edu | |
| Principal Investigator: Chittoor B Sai-Sudhakar, MBBS | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Michael Acker, MD 215-349-8305 michael.acker@uphs.upenn.edu | |
| Contact: Mary Lou Mayer, RN 215-662-7981 marylou.mayer@uphs.upenn.edu | |
| Principal Investigator: Michael Acker, MD | |
| United States, Texas | |
| Baylor Research Institute | Recruiting |
| Plano, Texas, United States, 75093 | |
| Contact: Michael Mack, MD 469-814-4105 michaelma@baylorhealth.edu | |
| Contact: Jennifer Withers, RN, CCRC 469-814-5691 jennw@baylorhealth.edu | |
| Principal Investigator: Michael Mack, MD | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Irving L. Kron, MD 434-924-2158 ilk@virginia.edu | |
| Contact: Sandra Burks, RN 434-243-0315 sgb2c@virginia.edu | |
| Principal Investigator: Irving L. Kron, MD | |
| Inova Heart and Vascular Institute | Recruiting |
| Falls Church, Virginia, United States, 22042 | |
| Contact: Alan Speir, MD 703-280-5858 ext 1106 aspeir1@gmail.com | |
| Contact: Minh Dang 703-776-6028 minh.dang@inova.org | |
| Principal Investigator: Alan Speir, MD | |
| Canada, Quebec | |
| Montreal Heart Institute | Recruiting |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Contact: Louis Perrault, MD, PhD 514 376-3330 louis.perrault@icm-mhi.org | |
| Contact: Sophie Robichaud 514-376-3330 ext 3305 Sophie.Robichaud@icm-mhi.org | |
| Principal Investigator: Louis Perrault, MD, PhD | |
| Hôpital du Sacré-Coeur de Montréal | Recruiting |
| Montreal, Quebec, Canada, QC H4J 1C5 | |
| Contact: Pierre Page, MD 514 338-2222 ext 3246 pierre.page@umontreal.ca | |
| Contact: Carole Sirois 514 338-2222 ext 3083 carole.sirois@crhsc.rtss.qc.ca | |
| Principal Investigator: Pierre Page, MD | |
| Canada | |
| Quebec Heart Institute/Laval Hopital | Recruiting |
| Quebec, Canada, H7M 3L9 | |
| Contact: Pierre Voisine, MD 418 656-4717 pierre.voisine@chg.ulaval.ca | |
| Contact: Gladys Dussault, RN 418-656-8711 ext 2765 gladys.dussault@criucpq.ulaval.ca | |
| Principal Investigator: Pierre Voisine, MD | |
| Study Chair: | Timothy Gardner, MD | Christiana Care Health System |
| Study Chair: | Patrick O'Gara, MD | Brigham and Women's Hospital |
More Information
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00806988 History of Changes |
| Obsolete Identifiers: | NCT00838786 |
| Other Study ID Numbers: | 594, U01 HL088942-01-1 |
| Study First Received: | December 10, 2008 |
| Last Updated: | February 17, 2012 |
| Health Authority: | United States: Federal Government Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee |
|
Ischemic Mitral Regurgitation Mitral Valve Regurgitation |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Mitral Valve Insufficiency Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Heart Valve Diseases |
