Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
4 de mayo de 2006 actualizado por: Anesiva, Inc.
A Phase III, Multi-Center Randomized, Double-Blind, Placebo-Controlled Trial of the Ex Vivo Treatment With CGT003 of Coronary Vein Grafts in Patients Undergoing Coronary Artery Bypass Graft Procedures
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción
3000
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35209
- Brookwood Medical Center
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Birmingham, Alabama, Estados Unidos, 35235
- Cardio-Thoracic Surgeons, P.C.
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Birmingham, Alabama, Estados Unidos, 35235
- Medical Center East
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Birmingham, Alabama, Estados Unidos, 35209
- Cardio-Thoracic Surgeons, P.C.
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Birmingham, Alabama, Estados Unidos, 35213
- Baptist Medical Center - Montclair
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Birmingham, Alabama, Estados Unidos, 35213
- Cardio-Thoracic Surgeons, P.C.
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California
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Daly City, California, Estados Unidos, 94015
- Seton Medical Center
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai Medical Center
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Palm Springs, California, Estados Unidos, 92262
- Desert Regional Medical Center
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Stockton, California, Estados Unidos, 95204
- St. Joseph's Medical Center
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Connecticut
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Bridgeport, Connecticut, Estados Unidos, 06606
- St. Vincent's Medical Center
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010
- Washington Hospital Center
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Florida
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Atlantis, Florida, Estados Unidos, 33462
- JFK Medical Center
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Atlantis, Florida, Estados Unidos, 33462
- Florida Cardiovascular Research
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Clearwater, Florida, Estados Unidos, 33756
- Morton Plant Hospital
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Melbourne, Florida, Estados Unidos, 32901
- Holmes Regional Medical Center
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Orlando, Florida, Estados Unidos, 32803
- Florida Hospital
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Orlando, Florida, Estados Unidos, 32806
- Orlando Heart Center
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Orlando, Florida, Estados Unidos, 32801
- Cardiovascular Surgeons, P.A.
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Orlando, Florida, Estados Unidos, 32806
- Orlando Cardiovascular Center, LLLP
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Orlando, Florida, Estados Unidos, 32806
- Orlando Regional Med Center
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Orlando, Florida, Estados Unidos, 32819
- Orlando Heart Center/Sand Lake
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Sarasota, Florida, Estados Unidos, 34239
- Clinical Research Center
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Sarasota, Florida, Estados Unidos, 34239
- Sarasota Memorial Health Care System
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital
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Atlanta, Georgia, Estados Unidos, 30308
- Crawford Long Hospital
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Illinois
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Belleville, Illinois, Estados Unidos, 62220
- St. Elizabeth's Hospital
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Belleville, Illinois, Estados Unidos, 62226
- Memorial Hospital
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Memorial Hospital
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Chicago, Illinois, Estados Unidos, 60631
- Resurrection Medical Center
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Chicago, Illinois, Estados Unidos, 60612
- Rush Presbyterian St. Luke's Medical Center
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Medical Facility Foundation
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Chicago, Illinois, Estados Unidos, 60612
- Rush Professional Building
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Evanston, Illinois, Estados Unidos, 60201
- Evanston Northwestern Healthcare
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Evanston, Illinois, Estados Unidos, 60202
- St. Francis Hospital of Evanston
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Evanston, Illinois, Estados Unidos, 60201
- Evanston Northwestern Healthcare, Highland Park Hospital
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Chicago Medical Center
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Naperville, Illinois, Estados Unidos, 60540
- Edward Hospital & Health Services
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Oak Lawn, Illinois, Estados Unidos, 60453
- Advocate Christ Hospital and Medical Center
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Peoria, Illinois, Estados Unidos, 61637
- OSF St. Francis Medical Center
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Springfield, Illinois, Estados Unidos, 62702
- Memorial Medical Center
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Springfield, Illinois, Estados Unidos, 62702
- St. John's Hospital
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Springfield, Illinois, Estados Unidos, 62702
- Southern Illinois University School of Medicine, Dep. of Surgery, Div. of Cardiothoracic Surgery
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Springfield, Illinois, Estados Unidos, 62702
- Southern Illinois University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery
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Winfield, Illinois, Estados Unidos, 60190
- Central DuPage Hospital
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46290
- The Heart Center of Indiana
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Indianapolis, Indiana, Estados Unidos, 46260
- St. Vincent Hospital and Health Care Service
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Iowa
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Davenport, Iowa, Estados Unidos, 52803
- Genesis Medical Center
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Davenport, Iowa, Estados Unidos, 52803
- Genesis Heart Institute
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Des Moines, Iowa, Estados Unidos, 50309
- Iowa Methodist Medical Center
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospitals and Clinics
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Kansas
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Overland Park, Kansas, Estados Unidos, 66204
- Georgetown Professional Plaza
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Shawnee Mission, Kansas, Estados Unidos, 66204
- Shawnee Mission Medical Center
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Jewish Hospital Health Care Services
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Maine
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Portland, Maine, Estados Unidos, 04102
- Maine Medical Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Hospital
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland Medical Center
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Baltimore, Maryland, Estados Unidos, 21215
- Cardiac Surgery Associates
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Salisbury, Maryland, Estados Unidos, 21801
- Peninsula Regional Medical Center
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Takoma Park, Maryland, Estados Unidos, 20912
- Washington Adventist Hospital
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Towson, Maryland, Estados Unidos, 21204
- St. Joseph Medical Center
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Towson, Maryland, Estados Unidos, 21204
- Cardiac Surgery Associates
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Towson, Maryland, Estados Unidos, 21204
- Midatlantic Cardiovascular Associates, P.A.
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham & Women's Hospital
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Medical Center
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Michigan
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Flint, Michigan, Estados Unidos, 48532
- McLaren Regional Medical Center
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Grand Rapids, Michigan, Estados Unidos, 49503
- Spectrum Health Hospitals
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Lansing, Michigan, Estados Unidos, 48910
- Ingham Regional Medical Center
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Lansing, Michigan, Estados Unidos, 48910
- Thoracic & Cardiovascular Healthcare Foundation
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Lansing, Michigan, Estados Unidos, 48910
- Thoracic & Cardiovascular Institute
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Petoskey, Michigan, Estados Unidos, 49770
- Northern Michigan Hospital
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Petoskey, Michigan, Estados Unidos, 49770
- Cardiology Consultants, PC
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Petoskey, Michigan, Estados Unidos, 49770
- Great Lakes Cardiothoracic and Vascular Surgery
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Petoskey, Michigan, Estados Unidos, 49770
- Petoskey Cardiology
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Saginaw, Michigan, Estados Unidos, 48601
- Michigan CardioVascular Institute
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Saginaw, Michigan, Estados Unidos, 48602
- Convenant Medical Center
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- St. Mary's/Duluth Clinic Health System
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Minneapolis, Minnesota, Estados Unidos, 55407
- Abbott Northwestern Hospital
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Minneapolis, Minnesota, Estados Unidos, 55416
- Park Nicollet Institute
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St. Louis Park, Minnesota, Estados Unidos, 55426
- Park Nicollet Heart Center
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St. Louis Park, Minnesota, Estados Unidos, 55426
- Methodist Hospital
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Mississippi
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Hattiesburg, Mississippi, Estados Unidos, 39401
- Forrest General Hospital
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Missouri
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Joplin, Missouri, Estados Unidos, 64804
- St. John's Regional Medical Center
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Kansas City, Missouri, Estados Unidos, 64114
- 930 Carondelet Drive
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St. Louis, Missouri, Estados Unidos, 63131
- Missouri Baptist Medical Center
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68114
- Nebraska Methodist Hospital
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Omaha, Nebraska, Estados Unidos, 68131
- University Of Nebraska Medical Center
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Omaha, Nebraska, Estados Unidos, 68131
- Nebraska Heart Institute
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Papillion, Nebraska, Estados Unidos, 68046
- Nebraska Heart Institute
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New Jersey
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Morristown, New Jersey, Estados Unidos, 07962
- Morristown Memorial Hospital
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New Brunswick, New Jersey, Estados Unidos, 08903
- Robert Wood Johnson University Hospital
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New Brunswick, New Jersey, Estados Unidos, 08903
- Umdnj-Rwjms
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Ridgewood, New Jersey, Estados Unidos, 07450
- The Valley Hospital
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New York
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New York, New York, Estados Unidos, 10021
- Lenox Hill Hospital
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New York, New York, Estados Unidos, 10032
- New York Presbyterian Medical Center, Milstein Hospital Building
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Valhalla, New York, Estados Unidos, 10595
- Westchester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27154
- University of North Carolina Hospitals
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Chapel Hill, North Carolina, Estados Unidos, 27514
- Ambulatory Care Center
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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Gastonia, North Carolina, Estados Unidos, 28054
- Gaston Memorial Hospital
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Greenville, North Carolina, Estados Unidos, 27834
- Pitt County Memorial Hospital
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Greenville, North Carolina, Estados Unidos, 27858
- Brody School of Medicine, East Carolina University
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Pinehurst, North Carolina, Estados Unidos, 28374
- FirstHealth Moore Regional Hospital
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Winston Salem, North Carolina, Estados Unidos, 27103
- Walley, Morgan & Duncan, M.D., P.A.
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Forysyth Medical Center
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58122
- MeritCare Medical Group
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Fargo, North Dakota, Estados Unidos, 58122
- MeritCare Clinic at MeritCare Hospital
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Ohio
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Akron, Ohio, Estados Unidos, 44307
- Akron General Medical Center
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Canton, Ohio, Estados Unidos, 44710
- Aultman Health Foundation
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Cincinnati, Ohio, Estados Unidos, 45242
- Bethesda North Hospital
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Cincinnati, Ohio, Estados Unidos, 45220
- Good Samaritan Hospital
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Cincinnati, Ohio, Estados Unidos, 45220
- Cardiovascular & Thoracic Surgeons
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Cincinnati, Ohio, Estados Unidos, 45242
- Cardiovascular & Thoracic Surgeons, Inc.
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Columbus, Ohio, Estados Unidos, 43214
- Riverside Methodist Hospital
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University Medical Center
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Kettering, Ohio, Estados Unidos, 45429
- Kettering Medical Center Network, Kettering Hospital
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Toledo, Ohio, Estados Unidos, 43608
- St. Vincent Mercy Medical Center
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Pennsylvania
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Bethlehem, Pennsylvania, Estados Unidos, 18015
- St. Luke's Hospital
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Presbyterian Hospital, University of Pennsylvania Health System
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Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center, Presbyterian Hospital
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Sayre, Pennsylvania, Estados Unidos, 18840
- Robert Packer Hospital
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Sayre, Pennsylvania, Estados Unidos, 18840
- Guthrie Clinic
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West Chester, Pennsylvania, Estados Unidos, 19380
- The Chester County Hospital
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Wynnewood, Pennsylvania, Estados Unidos, 19096
- Lankenau Hospital
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29605
- Greenville Hospital System
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Greenville, South Carolina, Estados Unidos, 29605
- Upstate Cardiothoracic Surgery, Greenville Hospital System
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38119
- Saint Francis Hospital
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Texas
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Austin, Texas, Estados Unidos, 78756
- Heart Hospital of Austin
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Dallas, Texas, Estados Unidos, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Estados Unidos, 75231
- Presbyterian Hospital of Dallas
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Dallas, Texas, Estados Unidos, 75235
- St. Paul University Hospital
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Denton, Texas, Estados Unidos, 76210
- Denton Regional Medical Center
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Plano, Texas, Estados Unidos, 75075
- Medical Center Plano
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San Antonio, Texas, Estados Unidos, 78229
- Southwest Texas Methodist Hospital
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San Antonio, Texas, Estados Unidos, 78233
- Northeast Methodist Hospital
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- University of Utah Health Sciences Center
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Virginia
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Lynchburg, Virginia, Estados Unidos, 24501
- Lynchburg General Hospital
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Norfolk, Virginia, Estados Unidos, 23507
- Sentara Norfolk General Hospital
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Norfolk, Virginia, Estados Unidos, 23510
- Mid-Atlantic Cardiothoracic Surgeons, Ltd.
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Washington
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Bellingham, Washington, Estados Unidos, 98225
- St. Joseph Hospital
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Spokane, Washington, Estados Unidos, 99204
- Deaconess Medical Center
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Spokane, Washington, Estados Unidos, 99204
- Northwest Heart and Lung Surgical Associates
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25304
- Charleston Area Medical Center
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Charleston, West Virginia, Estados Unidos, 25304
- CAMC Health Education and Research Institute, Clinical Trials Center
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Wisconsin
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Appleton, Wisconsin, Estados Unidos, 54911
- Appleton Heart Institute at Appleton Medical Center
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Milwaukee, Wisconsin, Estados Unidos, 53215
- St. Luke's Medical Center
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Waukesha, Wisconsin, Estados Unidos, 53188
- Waukesha Memorial Hospital
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Wausau, Wisconsin, Estados Unidos, 54401
- Wausau Heart and Lung Surgeons
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Wausau, Wisconsin, Estados Unidos, 54401
- Community Health Care/Wausau Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
PATIENTS MUST:
- Have coronary artery disease and be scheduled to undergo a coronary artery bypass (CABG) procedure that is to include at least two segments of autogenous vein (sequential grafts do not count as two separate grafts).
- Be between 18 and 80 years old.
- Have a documented negative serum pregnancy test for all women of childbearing potential.
- Be using an acceptable method of birth control if of reproductive potential.
- Have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form.
- (If one of the first 2400 patients enrolled) have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form for the Angiography population.
- Note: Patients who are to receive an arterial bypass to the left anterior descending artery in addition to the two vein grafts required by the protocol ARE eligible for this study.
- Note: Patients ARE eligible for enrollment regardless of whether the planned procedure is to be on or off cardiopulmonary bypass pump.
- Note: Patients who do not wish to undergo elective Angiography at one year SHOULD NOT be enrolled in the first 2400 patients.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Doble
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Todd Lorenz, M.D., Anesiva, Inc.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Alexander JH, Hafley G, Harrington RA, Peterson ED, Ferguson TB Jr, Lorenz TJ, Goyal A, Gibson M, Mack MJ, Gennevois D, Califf RM, Kouchoukos NT; PREVENT IV Investigators. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA. 2005 Nov 16;294(19):2446-54. doi: 10.1001/jama.294.19.2446.
- Harskamp RE, Alexander JH, Ferguson TB Jr, Hager R, Mack MJ, Englum B, Wojdyla D, Schulte PJ, Kouchoukos NT, de Winter RJ, Gibson CM, Peterson ED, Harrington RA, Smith PK, Lopes RD. Frequency and Predictors of Internal Mammary Artery Graft Failure and Subsequent Clinical Outcomes: Insights From the Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Trial. Circulation. 2016 Jan 12;133(2):131-8. doi: 10.1161/CIRCULATIONAHA.115.015549. Epub 2015 Dec 8.
- Hess CN, Lopes RD, Gibson CM, Hager R, Wojdyla DM, Englum BR, Mack MJ, Califf RM, Kouchoukos NT, Peterson ED, Alexander JH. Saphenous vein graft failure after coronary artery bypass surgery: insights from PREVENT IV. Circulation. 2014 Oct 21;130(17):1445-51. doi: 10.1161/CIRCULATIONAHA.113.008193. Epub 2014 Sep 26.
- Harskamp RE, Alexander JH, Schulte PJ, Brophy CM, Mack MJ, Peterson ED, Williams JB, Gibson CM, Califf RM, Kouchoukos NT, Harrington RA, Ferguson TB Jr, Lopes RD. Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial. JAMA Surg. 2014 Aug;149(8):798-805. doi: 10.1001/jamasurg.2014.87. Erratum In: JAMA Surg. 2014 Sep;149(9):961.
- Lopes RD, Williams JB, Mehta RH, Reyes EM, Hafley GE, Allen KB, Mack MJ, Peterson ED, Harrington RA, Gibson CM, Califf RM, Kouchoukos NT, Ferguson TB, Lorenz TJ, Alexander JH. Edifoligide and long-term outcomes after coronary artery bypass grafting: PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) 5-year results. Am Heart J. 2012 Sep;164(3):379-386.e1. doi: 10.1016/j.ahj.2012.05.019.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2002
Finalización del estudio
1 de febrero de 2005
Fechas de registro del estudio
Enviado por primera vez
22 de julio de 2002
Primero enviado que cumplió con los criterios de control de calidad
23 de julio de 2002
Publicado por primera vez (Estimar)
24 de julio de 2002
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
5 de mayo de 2006
Última actualización enviada que cumplió con los criterios de control de calidad
4 de mayo de 2006
Última verificación
1 de julio de 2005
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CGT003-04
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre CGT003 (señuelo dúplex E2F)
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Anesiva, Inc.TerminadoIsquemia | Enfermedades arteriales oclusivas | Enfermedades vasculares periféricas | Hiperplasia | Oclusión de Injerto, VascularEstados Unidos, Canadá
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Anesiva, Inc.TerminadoHiperplasia | Falla renal cronicaEstados Unidos