Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
2006年5月4日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册
3000
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Alabama
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Birmingham、Alabama、美国、35209
- Brookwood Medical Center
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Birmingham、Alabama、美国、35235
- Cardio-Thoracic Surgeons, P.C.
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Birmingham、Alabama、美国、35235
- Medical Center East
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Birmingham、Alabama、美国、35209
- Cardio-Thoracic Surgeons, P.C.
-
Birmingham、Alabama、美国、35213
- Baptist Medical Center - Montclair
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Birmingham、Alabama、美国、35213
- Cardio-Thoracic Surgeons, P.C.
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California
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Daly City、California、美国、94015
- Seton Medical Center
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Los Angeles、California、美国、90048
- Cedars-Sinai Medical Center
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Palm Springs、California、美国、92262
- Desert Regional Medical Center
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Stockton、California、美国、95204
- St. Joseph's Medical Center
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Connecticut
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Bridgeport、Connecticut、美国、06606
- St. Vincent's Medical Center
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District of Columbia
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Washington、District of Columbia、美国、20010
- Washington Hospital Center
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-
Florida
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Atlantis、Florida、美国、33462
- JFK Medical Center
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Atlantis、Florida、美国、33462
- Florida Cardiovascular Research
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Clearwater、Florida、美国、33756
- Morton Plant Hospital
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Melbourne、Florida、美国、32901
- Holmes Regional Medical Center
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Orlando、Florida、美国、32803
- Florida Hospital
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Orlando、Florida、美国、32806
- Orlando Heart Center
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Orlando、Florida、美国、32801
- Cardiovascular Surgeons, P.A.
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Orlando、Florida、美国、32806
- Orlando Cardiovascular Center, LLLP
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Orlando、Florida、美国、32806
- Orlando Regional Med Center
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Orlando、Florida、美国、32819
- Orlando Heart Center/Sand Lake
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Sarasota、Florida、美国、34239
- Clinical Research Center
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Sarasota、Florida、美国、34239
- Sarasota Memorial Health Care System
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Hospital
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Atlanta、Georgia、美国、30308
- Crawford Long Hospital
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Illinois
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Belleville、Illinois、美国、62220
- St. Elizabeth's Hospital
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Belleville、Illinois、美国、62226
- Memorial Hospital
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Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital
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Chicago、Illinois、美国、60631
- Resurrection Medical Center
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Chicago、Illinois、美国、60612
- Rush Presbyterian St. Luke's Medical Center
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Chicago、Illinois、美国、60611
- Northwestern Medical Facility Foundation
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Chicago、Illinois、美国、60612
- Rush Professional Building
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Evanston、Illinois、美国、60201
- Evanston Northwestern Healthcare
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Evanston、Illinois、美国、60202
- St. Francis Hospital of Evanston
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Evanston、Illinois、美国、60201
- Evanston Northwestern Healthcare, Highland Park Hospital
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Maywood、Illinois、美国、60153
- Loyola University Chicago Medical Center
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Naperville、Illinois、美国、60540
- Edward Hospital & Health Services
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Oak Lawn、Illinois、美国、60453
- Advocate Christ Hospital and Medical Center
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Peoria、Illinois、美国、61637
- OSF St. Francis Medical Center
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Springfield、Illinois、美国、62702
- Memorial Medical Center
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Springfield、Illinois、美国、62702
- St. John's Hospital
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Springfield、Illinois、美国、62702
- Southern Illinois University School of Medicine, Dep. of Surgery, Div. of Cardiothoracic Surgery
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Springfield、Illinois、美国、62702
- Southern Illinois University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery
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Winfield、Illinois、美国、60190
- Central DuPage Hospital
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Indiana
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Indianapolis、Indiana、美国、46290
- The Heart Center of Indiana
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Indianapolis、Indiana、美国、46260
- St. Vincent Hospital and Health Care Service
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Iowa
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Davenport、Iowa、美国、52803
- Genesis Medical Center
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Davenport、Iowa、美国、52803
- Genesis Heart Institute
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Des Moines、Iowa、美国、50309
- Iowa Methodist Medical Center
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Iowa City、Iowa、美国、52242
- University of Iowa Hospitals and Clinics
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Kansas
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Overland Park、Kansas、美国、66204
- Georgetown Professional Plaza
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Shawnee Mission、Kansas、美国、66204
- Shawnee Mission Medical Center
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Kentucky
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Louisville、Kentucky、美国、40202
- Jewish Hospital Health Care Services
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Maine
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Portland、Maine、美国、04102
- Maine Medical Center
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Maryland
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Baltimore、Maryland、美国、21215
- Sinai Hospital of Baltimore
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Baltimore、Maryland、美国、21287
- Johns Hopkins Hospital
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Baltimore、Maryland、美国、21201
- University of Maryland Medical Center
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Baltimore、Maryland、美国、21215
- Cardiac Surgery Associates
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Salisbury、Maryland、美国、21801
- Peninsula Regional Medical Center
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Takoma Park、Maryland、美国、20912
- Washington Adventist Hospital
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Towson、Maryland、美国、21204
- St. Joseph Medical Center
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Towson、Maryland、美国、21204
- Cardiac Surgery Associates
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Towson、Maryland、美国、21204
- Midatlantic Cardiovascular Associates, P.A.
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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Boston、Massachusetts、美国、02115
- Brigham & Women's Hospital
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Springfield、Massachusetts、美国、01199
- Baystate Medical Center
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Michigan
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Flint、Michigan、美国、48532
- McLaren Regional Medical Center
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Grand Rapids、Michigan、美国、49503
- Spectrum Health Hospitals
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Lansing、Michigan、美国、48910
- Ingham Regional Medical Center
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Lansing、Michigan、美国、48910
- Thoracic & Cardiovascular Healthcare Foundation
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Lansing、Michigan、美国、48910
- Thoracic & Cardiovascular Institute
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Petoskey、Michigan、美国、49770
- Northern Michigan Hospital
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Petoskey、Michigan、美国、49770
- Cardiology Consultants, PC
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Petoskey、Michigan、美国、49770
- Great Lakes Cardiothoracic and Vascular Surgery
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Petoskey、Michigan、美国、49770
- Petoskey Cardiology
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Saginaw、Michigan、美国、48601
- Michigan CardioVascular Institute
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Saginaw、Michigan、美国、48602
- Convenant Medical Center
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Minnesota
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Duluth、Minnesota、美国、55805
- St. Mary's/Duluth Clinic Health System
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Minneapolis、Minnesota、美国、55407
- Abbott Northwestern Hospital
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Minneapolis、Minnesota、美国、55416
- Park Nicollet Institute
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St. Louis Park、Minnesota、美国、55426
- Park Nicollet Heart Center
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St. Louis Park、Minnesota、美国、55426
- Methodist Hospital
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Mississippi
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Hattiesburg、Mississippi、美国、39401
- Forrest General Hospital
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Missouri
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Joplin、Missouri、美国、64804
- St. John's Regional Medical Center
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Kansas City、Missouri、美国、64114
- 930 Carondelet Drive
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St. Louis、Missouri、美国、63131
- Missouri Baptist Medical Center
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Nebraska
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Omaha、Nebraska、美国、68114
- Nebraska Methodist Hospital
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Omaha、Nebraska、美国、68131
- University of Nebraska Medical Center
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Omaha、Nebraska、美国、68131
- Nebraska Heart Institute
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Papillion、Nebraska、美国、68046
- Nebraska Heart Institute
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New Jersey
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Morristown、New Jersey、美国、07962
- Morristown Memorial Hospital
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New Brunswick、New Jersey、美国、08903
- Robert Wood Johnson University Hospital
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New Brunswick、New Jersey、美国、08903
- Umdnj-Rwjms
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Ridgewood、New Jersey、美国、07450
- The Valley Hospital
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New York
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New York、New York、美国、10021
- Lenox Hill Hospital
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New York、New York、美国、10032
- New York Presbyterian Medical Center, Milstein Hospital Building
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Valhalla、New York、美国、10595
- Westchester Medical Center
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North Carolina
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Chapel Hill、North Carolina、美国、27154
- University of North Carolina Hospitals
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Chapel Hill、North Carolina、美国、27514
- Ambulatory Care Center
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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Gastonia、North Carolina、美国、28054
- Gaston Memorial Hospital
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Greenville、North Carolina、美国、27834
- Pitt County Memorial Hospital
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Greenville、North Carolina、美国、27858
- Brody School of Medicine, East Carolina University
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Pinehurst、North Carolina、美国、28374
- FirstHealth Moore Regional Hospital
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Winston Salem、North Carolina、美国、27103
- Walley, Morgan & Duncan, M.D., P.A.
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Winston-Salem、North Carolina、美国、27103
- Forysyth Medical Center
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North Dakota
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Fargo、North Dakota、美国、58122
- MeritCare Medical Group
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Fargo、North Dakota、美国、58122
- MeritCare Clinic at MeritCare Hospital
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Ohio
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Akron、Ohio、美国、44307
- Akron General Medical Center
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Canton、Ohio、美国、44710
- Aultman Health Foundation
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Cincinnati、Ohio、美国、45242
- Bethesda North Hospital
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Cincinnati、Ohio、美国、45220
- Good Samaritan Hospital
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Cincinnati、Ohio、美国、45220
- Cardiovascular & Thoracic Surgeons
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Cincinnati、Ohio、美国、45242
- Cardiovascular & Thoracic Surgeons, Inc.
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Columbus、Ohio、美国、43214
- Riverside Methodist Hospital
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Columbus、Ohio、美国、43210
- The Ohio State University Medical Center
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Kettering、Ohio、美国、45429
- Kettering Medical Center Network, Kettering Hospital
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Toledo、Ohio、美国、43608
- St. Vincent Mercy Medical Center
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Pennsylvania
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Bethlehem、Pennsylvania、美国、18015
- St. Luke's Hospital
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Hershey、Pennsylvania、美国、17033
- Penn State Milton S. Hershey Medical Center
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Philadelphia、Pennsylvania、美国、19104
- Hospital of the University of Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Presbyterian Hospital, University of Pennsylvania Health System
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Pittsburgh、Pennsylvania、美国、15212
- Allegheny General Hospital
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center, Presbyterian Hospital
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Sayre、Pennsylvania、美国、18840
- Robert Packer Hospital
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Sayre、Pennsylvania、美国、18840
- Guthrie Clinic
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West Chester、Pennsylvania、美国、19380
- The Chester County Hospital
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Wynnewood、Pennsylvania、美国、19096
- Lankenau Hospital
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South Carolina
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Greenville、South Carolina、美国、29605
- Greenville Hospital System
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Greenville、South Carolina、美国、29605
- Upstate Cardiothoracic Surgery, Greenville Hospital System
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Tennessee
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Memphis、Tennessee、美国、38119
- Saint Francis Hospital
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Texas
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Austin、Texas、美国、78756
- Heart Hospital of Austin
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Dallas、Texas、美国、75230
- Medical City Dallas Hospital
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Dallas、Texas、美国、75231
- Presbyterian Hospital of Dallas
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Dallas、Texas、美国、75235
- St. Paul University Hospital
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Denton、Texas、美国、76210
- Denton Regional Medical Center
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Plano、Texas、美国、75075
- Medical Center Plano
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San Antonio、Texas、美国、78229
- Southwest Texas Methodist Hospital
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San Antonio、Texas、美国、78233
- Northeast Methodist Hospital
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Utah
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Salt Lake City、Utah、美国、84132
- University of Utah Health Sciences Center
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Virginia
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Lynchburg、Virginia、美国、24501
- Lynchburg General Hospital
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Norfolk、Virginia、美国、23507
- Sentara Norfolk General Hospital
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Norfolk、Virginia、美国、23510
- Mid-Atlantic Cardiothoracic Surgeons, Ltd.
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Washington
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Bellingham、Washington、美国、98225
- St. Joseph Hospital
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Spokane、Washington、美国、99204
- Deaconess Medical Center
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Spokane、Washington、美国、99204
- Northwest Heart and Lung Surgical Associates
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West Virginia
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Charleston、West Virginia、美国、25304
- Charleston Area Medical Center
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Charleston、West Virginia、美国、25304
- CAMC Health Education and Research Institute, Clinical Trials Center
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Wisconsin
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Appleton、Wisconsin、美国、54911
- Appleton Heart Institute at Appleton Medical Center
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Milwaukee、Wisconsin、美国、53215
- St. Luke's Medical Center
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Waukesha、Wisconsin、美国、53188
- Waukesha Memorial Hospital
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Wausau、Wisconsin、美国、54401
- Wausau Heart and Lung Surgeons
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Wausau、Wisconsin、美国、54401
- Community Health Care/Wausau Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：双倍的
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Todd Lorenz, M.D.、Anesiva, Inc.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2002年7月1日
研究完成
2005年2月1日
研究注册日期
首次提交
2002年7月22日
首先提交符合 QC 标准的
2002年7月23日
首次发布 (估计)
2002年7月24日
研究记录更新
最后更新发布 (估计)
2006年5月5日
上次提交的符合 QC 标准的更新
2006年5月4日
最后验证
2005年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.