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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

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ClinicalTrials.gov Identifier: NCT00806988
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
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

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
Enrollment 301

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mitral Valve Repair CABG
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 150 151
Completed 123 108
Not Completed 27 43
Reason Not Completed
Death             15             16
Withdrawal by Subject             8             8
Lost to Follow-up             4             19
Arm/Group Title Mitral Valve Repair CABG Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 150 151 301
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 151 participants 301 participants
64.3  (9.6) 65.2  (11.3) 64.7  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 151 participants 301 participants
Female
44
  29.3%
52
  34.4%
96
  31.9%
Male
106
  70.7%
99
  65.6%
205
  68.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 151 participants 301 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 151 participants 301 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 150 participants 151 participants 301 participants
Canada 35 36 71
United States 114 114 228
Denmark 1 1 2
1.Primary Outcome
Title Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)
Hide Description [Not Specified]
Time Frame Measured at Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mitral Valve Repair CABG
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 150 151
Mean (Standard Deviation)
Unit of Measure: ml per square meter
49.6  (31.5) 46.1  (22.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mitral Valve Repair, CABG
Comments The primary null hypothesis was that there would be no significant between-group difference in the LVESVI at 12 months.
Type of Statistical Test Other
Comments An intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level was used. This analysis accommodated missing LVESVI outcomes owing to death by assigning deceased patients the worst ranks in order according to the time of death. In the case of data that were missing for reasons other than death, we used multiple imputation to calculate the 12-month LVESVI on the assumption that the data were missing at random.
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Measured at Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mitral Valve Repair CABG
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 150 151
Measure Type: Count of Participants
Unit of Measure: Participants
46
  30.7%
48
  31.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mitral Valve Repair, CABG
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mitral Valve Repair CABG
Hide Arm/Group Description

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

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.

All-Cause Mortality
Mitral Valve Repair CABG
Affected / at Risk (%) Affected / at Risk (%)
Total   15/150 (10.00%)      16/151 (10.60%)    
Show Serious Adverse Events Hide Serious Adverse Events
Mitral Valve Repair CABG
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   88/150 (58.67%)      79/151 (52.32%)    
Blood and lymphatic system disorders     
Bleeding   2/150 (1.33%)  2 5/151 (3.31%)  6
Anemia   4/150 (2.67%)  5 1/151 (0.66%)  1
Coagulopathy/HIT   2/150 (1.33%)  2 1/151 (0.66%)  1
Coagulopathy/HIT (-)   1/150 (0.67%)  1 0/151 (0.00%)  0
Pancytopenia   0/150 (0.00%)  0 1/151 (0.66%)  1
Hemostasis   0/150 (0.00%)  0 1/151 (0.66%)  1
Right Axillary hematoma   1/150 (0.67%)  1 0/151 (0.00%)  0
Cardiac disorders     
Arrhythmias - Sustained ventricular arrhythmia   4/150 (2.67%)  4 5/151 (3.31%)  5
Arrhythmias - Sustained supraventricular arrhythmia   22/150 (14.67%)  24 11/151 (7.28%)  11
Pericardial Fluid Collection   2/150 (1.33%)  2 1/151 (0.66%)  1
Major Infection - Endocarditis   2/150 (1.33%)  2 1/151 (0.66%)  1
Myocardial infarction   1/150 (0.67%)  1 2/151 (1.32%)  2
Myocardial infarction - Peri-CABG MI   0/150 (0.00%)  0 1/151 (0.66%)  1
Myocardial infarction - Peri-Percutaneous Intervention MI   0/150 (0.00%)  0 1/151 (0.66%)  1
Heart Failure   26/150 (17.33%)  40 26/151 (17.22%)  39
2 Degree AV Block Type 1   1/150 (0.67%)  1 0/151 (0.00%)  0
Annuloplasty ring dehiscence   1/150 (0.67%)  1 0/151 (0.00%)  0
Bradyarrhythmia requiring pacemaker   5/150 (3.33%)  5 2/151 (1.32%)  2
Bradycardia   1/150 (0.67%)  1 0/151 (0.00%)  0
Bradycardia requiring pacemaker   0/150 (0.00%)  0 1/151 (0.66%)  1
Cardiogenic Shock   1/150 (0.67%)  1 2/151 (1.32%)  2
Carotid Disease   2/150 (1.33%)  2 1/151 (0.66%)  1
Chest Pain/ACS   3/150 (2.00%)  3 10/151 (6.62%)  15
Chest Pain/ACS/PCI   0/150 (0.00%)  0 1/151 (0.66%)  1
Heart Transplant   1/150 (0.67%)  1 0/151 (0.00%)  0
ICD Implant   2/150 (1.33%)  2 0/151 (0.00%)  0
LV apical cannula clot   1/150 (0.67%)  1 0/151 (0.00%)  0
Malfunctioning PM   1/150 (0.67%)  1 0/151 (0.00%)  0
Non Sustained VT   3/150 (2.00%)  3 0/151 (0.00%)  0
Pericarditis   1/150 (0.67%)  1 0/151 (0.00%)  0
R/O LV Thrombus   1/150 (0.67%)  1 0/151 (0.00%)  0
Syncope   3/150 (2.00%)  3 1/151 (0.66%)  1
Eye disorders     
Acute vision loss, non-neurological   1/150 (0.67%)  1 0/151 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain   1/150 (0.67%)  1 0/151 (0.00%)  0
Colitis   0/150 (0.00%)  0 1/151 (0.66%)  1
GI Bleed/GI Issue   7/150 (4.67%)  7 6/151 (3.97%)  6
Ischemic Bowel   0/150 (0.00%)  0 1/151 (0.66%)  1
Pill esophagitis   1/150 (0.67%)  1 0/151 (0.00%)  0
Small bowel obstruction/ileus   1/150 (0.67%)  1 1/151 (0.66%)  1
Ruptured appendix   0/150 (0.00%)  0 1/151 (0.66%)  1
Hepatobiliary disorders     
Hepatic Dysfunction   1/150 (0.67%)  1 1/151 (0.66%)  1
Cholelithiasis   0/150 (0.00%)  0 1/151 (0.66%)  1
Infections and infestations     
Major Infection - Localized   18/150 (12.00%)  25 15/151 (9.93%)  22
Major Infection - Sepsis   8/150 (5.33%)  9 6/151 (3.97%)  7
Abscess   0/150 (0.00%)  0 1/151 (0.66%)  1
Injury, poisoning and procedural complications     
Fall   1/150 (0.67%)  1 0/151 (0.00%)  0
Metabolism and nutrition disorders     
Electrolyte imbalance   2/150 (1.33%)  2 1/151 (0.66%)  1
Hyperglycemia   2/150 (1.33%)  2 2/151 (1.32%)  2
Musculoskeletal and connective tissue disorders     
Broken Bone   0/150 (0.00%)  0 1/151 (0.66%)  1
Sternal Non-Union   0/150 (0.00%)  0 1/151 (0.66%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer   2/150 (1.33%)  3 1/151 (0.66%)  1
Nervous system disorders     
Neurological Dysfunction - TIA   0/150 (0.00%)  0 1/151 (0.66%)  1
Neurological Dysfunction - CVA-Ischemic   6/150 (4.00%)  6 2/151 (1.32%)  2
Neurological Dysfunction - CVA-Hemorrhagic   1/150 (0.67%)  1 0/151 (0.00%)  0
Neurological Dysfunction - Toxic Metabolic Encephalopathy   3/150 (2.00%)  3 0/151 (0.00%)  0
Neurological Dysfunction - Other   4/150 (2.67%)  4 1/151 (0.66%)  1
Psychiatric disorders     
Depression and anxiety   0/150 (0.00%)  0 1/151 (0.66%)  1
Psychosis   0/150 (0.00%)  0 1/151 (0.66%)  1
Renal and urinary disorders     
Renal dysfunction (no dialysis)   7/150 (4.67%)  7 2/151 (1.32%)  2
Renal failure (dialysis)   5/150 (3.33%)  6 6/151 (3.97%)  7
Contrast induced nephropathy   0/150 (0.00%)  0 1/151 (0.66%)  1
Organ Transplant   1/150 (0.67%)  1 0/151 (0.00%)  0
Renal Calculi   1/150 (0.67%)  1 0/151 (0.00%)  0
Nephrectomy   1/150 (0.67%)  1 0/151 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure   9/150 (6.00%)  10 8/151 (5.30%)  9
Pleural Effusion   9/150 (6.00%)  12 8/151 (5.30%)  9
Pneumothorax   0/150 (0.00%)  0 6/151 (3.97%)  6
Asthma   0/150 (0.00%)  0 1/151 (0.66%)  1
Dyspnea   1/150 (0.67%)  1 0/151 (0.00%)  0
Hypoxia and respiratory insufficiency   1/150 (0.67%)  1 0/151 (0.00%)  0
Post anesthetic Hypoxia   0/150 (0.00%)  0 1/151 (0.66%)  1
Skin and subcutaneous tissue disorders     
Wound Dehiscence   3/150 (2.00%)  3 1/151 (0.66%)  1
Non-healing wound   0/150 (0.00%)  0 1/151 (0.66%)  1
Vascular disorders     
Arterial Non-CNS Thromboembolism   0/150 (0.00%)  0 2/151 (1.32%)  2
Venous Thromboembolism Event   4/150 (2.67%)  4 3/151 (1.99%)  3
Abdominal Aortic Aneurysm with claudication   0/150 (0.00%)  0 1/151 (0.66%)  1
Diabetic Foot Ulcer   0/150 (0.00%)  0 1/151 (0.66%)  1
Epistaxis   1/150 (0.67%)  2 0/151 (0.00%)  0
Gangrenous Toe   0/150 (0.00%)  0 1/151 (0.66%)  1
Hypertension   2/150 (1.33%)  2 0/151 (0.00%)  0
Ischemic Left hand   1/150 (0.67%)  1 0/151 (0.00%)  0
Left superficial femoral artery pseudoaneurysm   1/150 (0.67%)  1 0/151 (0.00%)  0
Lower extremity ischemia   1/150 (0.67%)  1 0/151 (0.00%)  0
Peripheral vascular disease   1/150 (0.67%)  1 3/151 (1.99%)  5
Peripheral vascular disease/BKA   0/150 (0.00%)  0 1/151 (0.66%)  1
Torn aorta   1/150 (0.67%)  1 0/151 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mitral Valve Repair CABG
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/150 (29.33%)      37/151 (24.50%)    
Cardiac disorders     
Arrhythmias - Sustained supraventricular arrhythmia   24/150 (16.00%)  25 18/151 (11.92%)  18
Myocardial infarction - Peri-CABG MI   0/150 (0.00%)  0 1/151 (0.66%)  1
Bradyarrhythmia requiring pacemaker   1/150 (0.67%)  1 0/151 (0.00%)  0
Gastrointestinal disorders     
Dysphagia   0/150 (0.00%)  0 1/151 (0.66%)  1
GI Bleed/GI Issue   0/150 (0.00%)  0 1/151 (0.66%)  1
Hemetemesis   1/150 (0.67%)  1 0/151 (0.00%)  0
Hepatobiliary disorders     
Hepatic Dysfunction   1/150 (0.67%)  1 0/151 (0.00%)  0
Infections and infestations     
Major Infection - Localized   13/150 (8.67%)  19 9/151 (5.96%)  11
Metabolism and nutrition disorders     
Gout   0/150 (0.00%)  0 1/151 (0.66%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer   0/150 (0.00%)  0 1/151 (0.66%)  1
Nervous system disorders     
Neurological Dysfunction - Toxic Metabolic Encephalopathy   4/150 (2.67%)  4 0/151 (0.00%)  0
Neurological Dysfunction - Other*   2/150 (1.33%)  2 1/151 (0.66%)  1
Renal and urinary disorders     
Renal dysfunction (no dialysis)   4/150 (2.67%)  4 0/151 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure   0/150 (0.00%)  0 1/151 (0.66%)  1
Pleural Effusion   6/150 (4.00%)  6 7/151 (4.64%)  7
Pneumothorax   0/150 (0.00%)  0 2/151 (1.32%)  2
Skin and subcutaneous tissue disorders     
Non-healing wound   0/150 (0.00%)  0 1/151 (0.66%)  1
Vascular disorders     
Venous Thromboembolism Event   0/150 (0.00%)  0 1/151 (0.66%)  1
Pressure ulcers   0/150 (0.00%)  0 1/151 (0.66%)  1
Neurological Dysfunction - TIA   1/150 (0.67%)  1 0/151 (0.00%)  0
Indicates events were collected by systematic assessment
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
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