search
Back to results

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

Primary Purpose

Mitral Valve Insufficiency, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mitral Valve Repair
CABG
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring Ischemic Mitral Regurgitation, Mitral Valve Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 or left atrial appendage excision)
  • 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)
  • 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

Sites / Locations

  • University of Southern California
  • Emory University
  • Wellstar Kennestone Hospital
  • University of Maryland
  • NIH Heart Center at Suburban Hospital
  • Brigham and Women's Hospital
  • Baystate Medical Center
  • Washington University
  • Montefiore Einstein Heart Center
  • Columbia University Medical Center
  • Mission Hospital
  • Duke University
  • East Carolina Heart Institute
  • Cleveland Clinic Foundation
  • Ohio State University
  • University of Pennsylvania
  • Baylor Research Institute
  • University of Virginia
  • Inova Heart and Vascular Institute
  • University of Alberta Hospital
  • University of Toronto Sunnybrook Health Science Centre
  • Saint Michael's Hospital
  • University of Toronto, Toronto General Hospital
  • Montreal Heart Institute
  • Hôpital du Sacré-Coeur de Montréal
  • Quebec Heart Institute/Laval Hopital
  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mitral Valve Repair

CABG

Arm Description

Participants will undergo CABG and a mitral valve repair procedure.

Participants will undergo CABG.

Outcomes

Primary Outcome Measures

Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2008
Last Updated
April 11, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR), National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00806988
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
Official Title
Surgical Interventions for Moderate Ischemic Mitral Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR), National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency, Coronary Artery Disease
Keywords
Ischemic Mitral Regurgitation, Mitral Valve Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mitral Valve Repair
Arm Type
Active Comparator
Arm Description
Participants will undergo CABG and a mitral valve repair procedure.
Arm Title
CABG
Arm Type
Active Comparator
Arm Description
Participants will undergo CABG.
Intervention Type
Procedure
Intervention Name(s)
Mitral Valve Repair
Intervention Description
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: 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. The heart will be arrested with cardioplegia. 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.
Intervention Type
Procedure
Intervention Name(s)
CABG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)
Time Frame
Measured at Month 12
Secondary Outcome Measure Information:
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
Time Frame
Measured at Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 or left atrial appendage excision) 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Gardner, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patrick O'Gara, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Annetine Gelijns, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Moskowitz, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30383
Country
United States
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
NIH Heart Center at Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Washington University
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montefiore Einstein Heart Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina Heart Institute
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baylor Research Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Heart and Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
University of Toronto Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Saint Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
University of Toronto, Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
QC H4J 1C5
Country
Canada
Facility Name
Quebec Heart Institute/Laval Hopital
City
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25405390
Citation
Smith PK, Puskas JD, Ascheim DD, Voisine P, Gelijns AC, Moskowitz AJ, Hung JW, Parides MK, Ailawadi G, Perrault LP, Acker MA, Argenziano M, Thourani V, Gammie JS, Miller MA, Page P, Overbey JR, Bagiella E, Dagenais F, Blackstone EH, Kron IL, Goldstein DJ, Rose EA, Moquete EG, Jeffries N, Gardner TJ, O'Gara PT, Alexander JH, Michler RE; Cardiothoracic Surgical Trials Network Investigators. Surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med. 2014 Dec 4;371(23):2178-88. doi: 10.1056/NEJMoa1410490. Epub 2014 Nov 18.
Results Reference
result
PubMed Identifier
33573741
Citation
Bertrand PB, Overbey JR, Zeng X, Levine RA, Ailawadi G, Acker MA, Smith PK, Thourani VH, Bagiella E, Miller MA, Gupta L, Mack MJ, Gillinov AM, Giustino G, Moskowitz AJ, Gelijns AC, Bowdish ME, O'Gara PT, Gammie JS, Hung J; Cardiothoracic Surgical Trials Network (CTSN). Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation. J Am Coll Cardiol. 2021 Feb 16;77(6):713-724. doi: 10.1016/j.jacc.2020.11.066.
Results Reference
derived
PubMed Identifier
27777294
Citation
Capoulade R, Zeng X, Overbey JR, Ailawadi G, Alexander JH, Ascheim D, Bowdish M, Gelijns AC, Grayburn P, Kron IL, Levine RA, Mack MJ, Melnitchouk S, Michler RE, Mullen JC, O'Gara P, Parides MK, Smith P, Voisine P, Hung J; Cardiothoracic Surgical Trials Network (CTSN) Investigators. Impact of Left Ventricular to Mitral Valve Ring Mismatch on Recurrent Ischemic Mitral Regurgitation After Ring Annuloplasty. Circulation. 2016 Oct 25;134(17):1247-1256. doi: 10.1161/CIRCULATIONAHA.115.021014.
Results Reference
derived
PubMed Identifier
27040451
Citation
Michler RE, Smith PK, Parides MK, Ailawadi G, Thourani V, Moskowitz AJ, Acker MA, Hung JW, Chang HL, Perrault LP, Gillinov AM, Argenziano M, Bagiella E, Overbey JR, Moquete EG, Gupta LN, Miller MA, Taddei-Peters WC, Jeffries N, Weisel RD, Rose EA, Gammie JS, DeRose JJ Jr, Puskas JD, Dagenais F, Burks SG, El-Hamamsy I, Milano CA, Atluri P, Voisine P, O'Gara PT, Gelijns AC; CTSN. Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation. N Engl J Med. 2016 May 19;374(20):1932-41. doi: 10.1056/NEJMoa1602003. Epub 2016 Apr 3.
Results Reference
derived
Links:
URL
http://www.ctsurgerynet.org/
Description
Click here for the Cardiothoracic Surgical Trials Network Web site.

Learn more about this trial

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

We'll reach out to this number within 24 hrs