Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00042081
- Lead Sponsor
- Anesiva, Inc.
- Brief Summary
The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft failure after coronary artery bypass surgery.
- Detailed Description
Coronary vascular disease manifested by narrowing of the coronary arteries is one of the more common manifestations of atherosclerotic vascular disease. The clinical manifestations of coronary artery disease include death, angina pectoris, myocardial infarction, congestive heart failure and arrhythmia. Restoration of circulation to the heart may be undertaken using a variety of techniques including angioplasty, stenting, and bypass grafting.
Approximately 359,000 patients underwent coronary bypass procedures in the U.S. in 1999. Long term studies have observed an incidence of vein graft occlusion at 19% at 1 year, 25% at 5 years and 50% by 15 years after operation for an overall rate of 2.5% per year after the first year of observation. The consequences of graft failure are as significant as those of primary atherosclerotic disease and include ischemia, myocardial infarction and death.
CGT003 is a novel therapeutic that is under investigation as a treatment to prevent vein graft failure. It acts by inhibiting the transcription factor, E2F, which is activated in response to injury such as that which occurs when thin-walled vein grafts are exposed to the pressures of the arterial circulation. Blockade of E2F inhibits smooth muscle cell proliferation and redirects the vein graft remodeling that occurs within the first several days after implantation towards medial hypertrophy and strengthening of the medial layer and blunts formation of neointima. Inhibition of neotinimal formation coupled with expansion of the media should result in a decreased risk of the accelerated atherosclerosis and consequent vein graft failure over several years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (150)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Presbyterian Hospital, University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
St. Vincent's Medical Center
🇺🇸Bridgeport, Connecticut, United States
Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
Missouri Baptist Medical Center
🇺🇸St. Louis, Missouri, United States
Brody School of Medicine, East Carolina University
🇺🇸Greenville, North Carolina, United States
Wausau Heart and Lung Surgeons
🇺🇸Wausau, Wisconsin, United States
St. Mary's/Duluth Clinic Health System
🇺🇸Duluth, Minnesota, United States
Community Health Care/Wausau Hospital
🇺🇸Wausau, Wisconsin, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Umdnj-Rwjms
🇺🇸New Brunswick, New Jersey, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Northwestern Medical Facility Foundation
🇺🇸Chicago, Illinois, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Rush Presbyterian St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Resurrection Medical Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
St. Vincent Hospital and Health Care Service
🇺🇸Indianapolis, Indiana, United States
The Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Park Nicollet Institute
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
Southwest Texas Methodist Hospital
🇺🇸San Antonio, Texas, United States
Cardiovascular & Thoracic Surgeons
🇺🇸Cincinnati, Ohio, United States
Northeast Methodist Hospital
🇺🇸San Antonio, Texas, United States
Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Memorial Hospital
🇺🇸Belleville, Illinois, United States
St. Elizabeth's Hospital
🇺🇸Belleville, Illinois, United States
Clinical Research Center
🇺🇸Sarasota, Florida, United States
Evanston Northwestern Healthcare, Highland Park Hospital
🇺🇸Evanston, Illinois, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
St. Joseph's Medical Center
🇺🇸Stockton, California, United States
Advocate Christ Hospital and Medical Center
🇺🇸Oak Lawn, Illinois, United States
Florida Cardiovascular Research
🇺🇸Atlantis, Florida, United States
St. Francis Hospital of Evanston
🇺🇸Evanston, Illinois, United States
Georgetown Professional Plaza
🇺🇸Overland Park, Kansas, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Genesis Heart Institute
🇺🇸Davenport, Iowa, United States
Seton Medical Center
🇺🇸Daly City, California, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Convenant Medical Center
🇺🇸Saginaw, Michigan, United States
St. Paul University Hospital
🇺🇸Dallas, Texas, United States
Southern Illinois University School of Medicine, Dep. of Surgery, Div. of Cardiothoracic Surgery
🇺🇸Springfield, Illinois, United States
Spectrum Health Hospitals
🇺🇸Grand Rapids, Michigan, United States
New York Presbyterian Medical Center, Milstein Hospital Building
🇺🇸New York, New York, United States
Edward Hospital & Health Services
🇺🇸Naperville, Illinois, United States
Gaston Memorial Hospital
🇺🇸Gastonia, North Carolina, United States
MeritCare Clinic at MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Thoracic & Cardiovascular Institute
🇺🇸Lansing, Michigan, United States
St. John's Regional Medical Center
🇺🇸Joplin, Missouri, United States
Pitt County Memorial Hospital
🇺🇸Greenville, North Carolina, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Park Nicollet Heart Center
🇺🇸St. Louis Park, Minnesota, United States
Shawnee Mission Medical Center
🇺🇸Shawnee Mission, Kansas, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Saint Francis Hospital
🇺🇸Memphis, Tennessee, United States
Medical Center Plano
🇺🇸Plano, Texas, United States
Forrest General Hospital
🇺🇸Hattiesburg, Mississippi, United States
Nebraska Heart Institute
🇺🇸Papillion, Nebraska, United States
MeritCare Medical Group
🇺🇸Fargo, North Dakota, United States
Methodist Hospital
🇺🇸St. Louis Park, Minnesota, United States
Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
Walley, Morgan & Duncan, M.D., P.A.
🇺🇸Winston Salem, North Carolina, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Cardiovascular & Thoracic Surgeons, Inc.
🇺🇸Cincinnati, Ohio, United States
St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Presbyterian Hospital of Dallas
🇺🇸Dallas, Texas, United States
CAMC Health Education and Research Institute, Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
Lynchburg General Hospital
🇺🇸Lynchburg, Virginia, United States
St. Joseph Hospital
🇺🇸Bellingham, Washington, United States
Denton Regional Medical Center
🇺🇸Denton, Texas, United States
Northwest Heart and Lung Surgical Associates
🇺🇸Spokane, Washington, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Brookwood Medical Center
🇺🇸Birmingham, Alabama, United States
Cardio-Thoracic Surgeons, P.C.
🇺🇸Birmingham, Alabama, United States
Medical Center East
🇺🇸Birmingham, Alabama, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
University of Pittsburgh Medical Center, Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Guthrie Clinic
🇺🇸Sayre, Pennsylvania, United States
The Chester County Hospital
🇺🇸West Chester, Pennsylvania, United States
Mid-Atlantic Cardiothoracic Surgeons, Ltd.
🇺🇸Norfolk, Virginia, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Robert Packer Hospital
🇺🇸Sayre, Pennsylvania, United States
Baptist Medical Center - Montclair
🇺🇸Birmingham, Alabama, United States
JFK Medical Center
🇺🇸Atlantis, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Desert Regional Medical Center
🇺🇸Palm Springs, California, United States
Sarasota Memorial Health Care System
🇺🇸Sarasota, Florida, United States
Rush Professional Building
🇺🇸Chicago, Illinois, United States
Southern Illinois University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery
🇺🇸Springfield, Illinois, United States
Loyola University Chicago Medical Center
🇺🇸Maywood, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Cardiac Surgery Associates
🇺🇸Towson, Maryland, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Midatlantic Cardiovascular Associates, P.A.
🇺🇸Towson, Maryland, United States
Thoracic & Cardiovascular Healthcare Foundation
🇺🇸Lansing, Michigan, United States
McLaren Regional Medical Center
🇺🇸Flint, Michigan, United States
Cardiology Consultants, PC
🇺🇸Petoskey, Michigan, United States
Great Lakes Cardiothoracic and Vascular Surgery
🇺🇸Petoskey, Michigan, United States
Petoskey Cardiology
🇺🇸Petoskey, Michigan, United States
Michigan Cardiovascular Institute
🇺🇸Saginaw, Michigan, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Aultman Health Foundation
🇺🇸Canton, Ohio, United States
Kettering Medical Center Network, Kettering Hospital
🇺🇸Kettering, Ohio, United States
Upstate Cardiothoracic Surgery, Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Appleton Heart Institute at Appleton Medical Center
🇺🇸Appleton, Wisconsin, United States
Cardiovascular Surgeons, P.A.
🇺🇸Orlando, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Orlando Cardiovascular Center, LLLP
🇺🇸Orlando, Florida, United States
Orlando Heart Center
🇺🇸Orlando, Florida, United States
Orlando Regional Med Center
🇺🇸Orlando, Florida, United States
Orlando Heart Center/Sand Lake
🇺🇸Orlando, Florida, United States
Jewish Hospital Health Care Services
🇺🇸Louisville, Kentucky, United States
Forysyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
930 Carondelet Drive
🇺🇸Kansas City, Missouri, United States
University of North Carolina Hospitals
🇺🇸Chapel Hill, North Carolina, United States
Ambulatory Care Center
🇺🇸Chapel Hill, North Carolina, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States