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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806988
First Posted: December 11, 2008
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Alan Moskowitz, Icahn School of Medicine at Mount Sinai
Results First Submitted: April 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Mitral Valve Insufficiency
Coronary Artery Disease
Interventions: Procedure: Mitral Valve Repair
Procedure: CABG

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mitral Valve Repair

Participants will undergo CABG and a mitral valve repair 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:

  1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
  2. The heart will be arrested with cardioplegia.
  3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.

CABG: CABG will be performed using

CABG

Participants will undergo CABG.

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.


Participant Flow:   Overall Study
    Mitral Valve Repair   CABG
STARTED   150   151 
COMPLETED   123   108 
NOT COMPLETED   27   43 
Death                15                16 
Withdrawal by Subject                8                8 
Lost to Follow-up                4                19 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mitral Valve Repair

Participants will undergo CABG and a mitral valve repair 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:

  1. All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.
  2. The heart will be arrested with cardioplegia.
  3. A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.

CABG: CABG will be performed using

CABG

Participants will undergo CABG.

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.

Total Total of all reporting groups

Baseline Measures
   Mitral Valve Repair   CABG   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   151   301 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (9.6)   65.2  (11.3)   64.7  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      44  29.3%      52  34.4%      96  31.9% 
Male      106  70.7%      99  65.6%      205  68.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      12   8.0%      14   9.3%      26   8.6% 
Not Hispanic or Latino      138  92.0%      137  90.7%      275  91.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   1.3%      1   0.7%      3   1.0% 
Asian      2   1.3%      7   4.6%      9   3.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      29  19.3%      21  13.9%      50  16.6% 
White      115  76.7%      122  80.8%      237  78.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2   1.3%      0   0.0%      2   0.7% 
Region of Enrollment 
[Units: Participants]
     
Canada   35   36   71 
United States   114   114   228 
Denmark   1   1   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)   [ Time Frame: Measured at Month 12 ]

2.  Secondary:   Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention   [ Time Frame: Measured at Month 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alan Moskowitz, MD
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-659-9568
e-mail: alan.moskowitz@mountsinai.org


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alan Moskowitz, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00806988     History of Changes
Obsolete Identifiers: NCT00838786
Other Study ID Numbers: GCO 08-1078-00003
U01HL088942 ( U.S. NIH Grant/Contract )
594 ( Other Identifier: Ct Surgery Network Research Group )
First Submitted: December 10, 2008
First Posted: December 11, 2008
Results First Submitted: April 11, 2017
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017