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Trial NCT00806988

Resource URI: http://static.linkedct.org/resource/trials/NCT00806988
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/20065>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/8383>
linkedct:brief_title Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5468>
linkedct:condition <http://static.linkedct.org/resource/condition/3372>
linkedct:condition <http://static.linkedct.org/resource/condition/8191>
linkedct:criteria Inclusion Criteria: - Moderate mitral regurgitation 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. see appendix). Quantitative guidelines as proposed would be: ERO between 0.2 cmsq to 0.39 cmsq. If ERO < 0.2, 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 - CAD that is amenable to CABG and a clinical indication for revascularization - Age  18 years Exclusion Criteria: - Any evidence of structural (chordal or leaflet) mitral valve disease - Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography - Planned concomitant intra-operative procedures (with the exception of closure of patent foramen ovale [PFO] or atrial septal defect [ASD]or Maze procedure) - Prior surgical or percutaneous mitral valve repair - Contraindication to cardiopulmonary bypass (CPB) - Clinical signs of cardiogenic shock at the time of surgery - Treatment with chronic intravenous inotropic therapy at the time of surgery - Severe, irreversible pulmonary hypertension in the judgment of the investigator - ST segment elevation myocardial infarction (MI) requiring intervention in the 7 days before surgery - Congenital heart disease (except PFO or ASD) - Long-term kidney insufficiency, defined by creatinine (Cr) level greater than or equal to 2.5 or chronic kidney replacement therapy (long-term hemo- or peritoneal dialysis) - Evidence of cirrhosis or liver synthetic failure - Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, in the judgment of the investigator - Therapy with an investigational intervention at the time of screening, or planning to enroll in an additional investigational intervention study during participation in the study - Any concurrent disease with a life expectancy of less than 2 years - Pregnancy at the time of randomization
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date November 2011
linkedct:enrollment 300 (xsd:int)
linkedct:firstreceived_date December 10, 2008
linkedct:has_dmc Yes
linkedct:id NCT00806988
linkedct:intervention <http://static.linkedct.org/resource/intervention/73708>
linkedct:intervention <http://static.linkedct.org/resource/intervention/96873>
rdfs:label Trial NCT00806988
linkedct:lastchanged_date October 16, 2009
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:location <http://static.linkedct.org/resource/location/153915>
linkedct:location <http://static.linkedct.org/resource/location/160181>
linkedct:location <http://static.linkedct.org/resource/location/164325>
linkedct:location <http://static.linkedct.org/resource/location/167099>
linkedct:location <http://static.linkedct.org/resource/location/17417>
linkedct:location <http://static.linkedct.org/resource/location/182957>
linkedct:location <http://static.linkedct.org/resource/location/270473>
linkedct:location <http://static.linkedct.org/resource/location/270717>
linkedct:location <http://static.linkedct.org/resource/location/300533>
linkedct:location <http://static.linkedct.org/resource/location/301738>
linkedct:nct_id NCT00806988
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Surgical Interventions for Moderate Ischemic Mitral Regurgitation
linkedct:org_study_id 594
linkedct:overall_contact_email annetine.gelijns@mssm.edu
linkedct:overall_contact_last_name Annetine Gelijns, PhD
linkedct:overall_contact_phone 212-659-9568
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/45509>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/58734>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
linkedct:oversight <http://static.linkedct.org/resource/oversight/402>
linkedct:oversight <http://static.linkedct.org/resource/oversight/410>
foaf:page <http://clinicaltrials.gov/show/NCT00806988>
linkedct:phase Phase 2
linkedct:primary_completion_date November 2010
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/67329>
linkedct:secondary_id U01 HL088942-01-1
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/63367>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date December 2008
linkedct:study_design Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date October 2009