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Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures

4. maj 2006 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Koronararteriesygdom

Intervention / Behandling

Medicin: CGT003 (E2F Duplex Decoy)

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding

3000

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35209
    - Brookwood Medical Center
  - Birmingham, Alabama, Forenede Stater, 35235
    - Cardio-Thoracic Surgeons, P.C.
  - Birmingham, Alabama, Forenede Stater, 35235
    - Medical Center East
  - Birmingham, Alabama, Forenede Stater, 35209
    - Cardio-Thoracic Surgeons, P.C.
  - Birmingham, Alabama, Forenede Stater, 35213
    - Baptist Medical Center - Montclair
  - Birmingham, Alabama, Forenede Stater, 35213
    - Cardio-Thoracic Surgeons, P.C.
- California
  - Daly City, California, Forenede Stater, 94015
    - Seton Medical Center
  - Los Angeles, California, Forenede Stater, 90048
    - Cedars-Sinai Medical Center
  - Palm Springs, California, Forenede Stater, 92262
    - Desert Regional Medical Center
  - Stockton, California, Forenede Stater, 95204
    - St. Joseph's Medical Center
- Connecticut
  - Bridgeport, Connecticut, Forenede Stater, 06606
    - St. Vincent's Medical Center
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20010
    - Washington Hospital Center
- Florida
  - Atlantis, Florida, Forenede Stater, 33462
    - JFK Medical Center
  - Atlantis, Florida, Forenede Stater, 33462
    - Florida Cardiovascular Research
  - Clearwater, Florida, Forenede Stater, 33756
    - Morton Plant Hospital
  - Melbourne, Florida, Forenede Stater, 32901
    - Holmes Regional Medical Center
  - Orlando, Florida, Forenede Stater, 32803
    - Florida Hospital
  - Orlando, Florida, Forenede Stater, 32806
    - Orlando Heart Center
  - Orlando, Florida, Forenede Stater, 32801
    - Cardiovascular Surgeons, P.A.
  - Orlando, Florida, Forenede Stater, 32806
    - Orlando Cardiovascular Center, LLLP
  - Orlando, Florida, Forenede Stater, 32806
    - Orlando Regional Med Center
  - Orlando, Florida, Forenede Stater, 32819
    - Orlando Heart Center/Sand Lake
  - Sarasota, Florida, Forenede Stater, 34239
    - Clinical Research Center
  - Sarasota, Florida, Forenede Stater, 34239
    - Sarasota Memorial Health Care System
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30322
    - Emory University Hospital
  - Atlanta, Georgia, Forenede Stater, 30308
    - Crawford Long Hospital
- Illinois
  - Belleville, Illinois, Forenede Stater, 62220
    - St. Elizabeth's Hospital
  - Belleville, Illinois, Forenede Stater, 62226
    - Memorial Hospital
  - Chicago, Illinois, Forenede Stater, 60611
    - Northwestern Memorial Hospital
  - Chicago, Illinois, Forenede Stater, 60631
    - Resurrection Medical Center
  - Chicago, Illinois, Forenede Stater, 60612
    - Rush Presbyterian St. Luke's Medical Center
  - Chicago, Illinois, Forenede Stater, 60611
    - Northwestern Medical Facility Foundation
  - Chicago, Illinois, Forenede Stater, 60612
    - Rush Professional Building
  - Evanston, Illinois, Forenede Stater, 60201
    - Evanston Northwestern Healthcare
  - Evanston, Illinois, Forenede Stater, 60202
    - St. Francis Hospital of Evanston
  - Evanston, Illinois, Forenede Stater, 60201
    - Evanston Northwestern Healthcare, Highland Park Hospital
  - Maywood, Illinois, Forenede Stater, 60153
    - Loyola University Chicago Medical Center
  - Naperville, Illinois, Forenede Stater, 60540
    - Edward Hospital & Health Services
  - Oak Lawn, Illinois, Forenede Stater, 60453
    - Advocate Christ Hospital and Medical Center
  - Peoria, Illinois, Forenede Stater, 61637
    - OSF St. Francis Medical Center
  - Springfield, Illinois, Forenede Stater, 62702
    - Memorial Medical Center
  - Springfield, Illinois, Forenede Stater, 62702
    - St. John's Hospital
  - Springfield, Illinois, Forenede Stater, 62702
    - Southern Illinois University School of Medicine, Dep. of Surgery, Div. of Cardiothoracic Surgery
  - Springfield, Illinois, Forenede Stater, 62702
    - Southern Illinois University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery
  - Winfield, Illinois, Forenede Stater, 60190
    - Central DuPage Hospital
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46290
    - The Heart Center of Indiana
  - Indianapolis, Indiana, Forenede Stater, 46260
    - St. Vincent Hospital and Health Care Service
- Iowa
  - Davenport, Iowa, Forenede Stater, 52803
    - Genesis Medical Center
  - Davenport, Iowa, Forenede Stater, 52803
    - Genesis Heart Institute
  - Des Moines, Iowa, Forenede Stater, 50309
    - Iowa Methodist Medical Center
  - Iowa City, Iowa, Forenede Stater, 52242
    - University of Iowa Hospitals and Clinics
- Kansas
  - Overland Park, Kansas, Forenede Stater, 66204
    - Georgetown Professional Plaza
  - Shawnee Mission, Kansas, Forenede Stater, 66204
    - Shawnee Mission Medical Center
- Kentucky
  - Louisville, Kentucky, Forenede Stater, 40202
    - Jewish Hospital Health Care Services
- Maine
  - Portland, Maine, Forenede Stater, 04102
    - Maine Medical Center
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21215
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, Forenede Stater, 21287
    - Johns Hopkins Hospital
  - Baltimore, Maryland, Forenede Stater, 21201
    - University of Maryland Medical Center
  - Baltimore, Maryland, Forenede Stater, 21215
    - Cardiac Surgery Associates
  - Salisbury, Maryland, Forenede Stater, 21801
    - Peninsula Regional Medical Center
  - Takoma Park, Maryland, Forenede Stater, 20912
    - Washington Adventist Hospital
  - Towson, Maryland, Forenede Stater, 21204
    - St. Joseph Medical Center
  - Towson, Maryland, Forenede Stater, 21204
    - Cardiac Surgery Associates
  - Towson, Maryland, Forenede Stater, 21204
    - Midatlantic Cardiovascular Associates, P.A.
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, Forenede Stater, 02115
    - Brigham & Women's Hospital
  - Springfield, Massachusetts, Forenede Stater, 01199
    - Baystate Medical Center
- Michigan
  - Flint, Michigan, Forenede Stater, 48532
    - McLaren Regional Medical Center
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Spectrum Health Hospitals
  - Lansing, Michigan, Forenede Stater, 48910
    - Ingham Regional Medical Center
  - Lansing, Michigan, Forenede Stater, 48910
    - Thoracic & Cardiovascular Healthcare Foundation
  - Lansing, Michigan, Forenede Stater, 48910
    - Thoracic & Cardiovascular Institute
  - Petoskey, Michigan, Forenede Stater, 49770
    - Northern Michigan Hospital
  - Petoskey, Michigan, Forenede Stater, 49770
    - Cardiology Consultants, PC
  - Petoskey, Michigan, Forenede Stater, 49770
    - Great Lakes Cardiothoracic and Vascular Surgery
  - Petoskey, Michigan, Forenede Stater, 49770
    - Petoskey Cardiology
  - Saginaw, Michigan, Forenede Stater, 48601
    - Michigan CardioVascular Institute
  - Saginaw, Michigan, Forenede Stater, 48602
    - Convenant Medical Center
- Minnesota
  - Duluth, Minnesota, Forenede Stater, 55805
    - St. Mary's/Duluth Clinic Health System
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Abbott Northwestern Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55416
    - Park Nicollet Institute
  - St. Louis Park, Minnesota, Forenede Stater, 55426
    - Park Nicollet Heart Center
  - St. Louis Park, Minnesota, Forenede Stater, 55426
    - Methodist Hospital
- Mississippi
  - Hattiesburg, Mississippi, Forenede Stater, 39401
    - Forrest General Hospital
- Missouri
  - Joplin, Missouri, Forenede Stater, 64804
    - St. John's Regional Medical Center
  - Kansas City, Missouri, Forenede Stater, 64114
    - 930 Carondelet Drive
  - St. Louis, Missouri, Forenede Stater, 63131
    - Missouri Baptist Medical Center
- Nebraska
  - Omaha, Nebraska, Forenede Stater, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, Forenede Stater, 68131
    - University of Nebraska Medical Center
  - Omaha, Nebraska, Forenede Stater, 68131
    - Nebraska Heart Institute
  - Papillion, Nebraska, Forenede Stater, 68046
    - Nebraska Heart Institute
- New Jersey
  - Morristown, New Jersey, Forenede Stater, 07962
    - Morristown Memorial Hospital
  - New Brunswick, New Jersey, Forenede Stater, 08903
    - Robert Wood Johnson University Hospital
  - New Brunswick, New Jersey, Forenede Stater, 08903
    - Umdnj-Rwjms
  - Ridgewood, New Jersey, Forenede Stater, 07450
    - The Valley Hospital
- New York
  - New York, New York, Forenede Stater, 10021
    - Lenox Hill Hospital
  - New York, New York, Forenede Stater, 10032
    - New York Presbyterian Medical Center, Milstein Hospital Building
  - Valhalla, New York, Forenede Stater, 10595
    - Westchester Medical Center
- North Carolina
  - Chapel Hill, North Carolina, Forenede Stater, 27154
    - University of North Carolina Hospitals
  - Chapel Hill, North Carolina, Forenede Stater, 27514
    - Ambulatory Care Center
  - Durham, North Carolina, Forenede Stater, 27710
    - Duke University Medical Center
  - Gastonia, North Carolina, Forenede Stater, 28054
    - Gaston Memorial Hospital
  - Greenville, North Carolina, Forenede Stater, 27834
    - Pitt County Memorial Hospital
  - Greenville, North Carolina, Forenede Stater, 27858
    - Brody School of Medicine, East Carolina University
  - Pinehurst, North Carolina, Forenede Stater, 28374
    - Firsthealth Moore Regional Hospital
  - Winston Salem, North Carolina, Forenede Stater, 27103
    - Walley, Morgan & Duncan, M.D., P.A.
  - Winston-Salem, North Carolina, Forenede Stater, 27103
    - Forysyth Medical Center
- North Dakota
  - Fargo, North Dakota, Forenede Stater, 58122
    - MeritCare Medical Group
  - Fargo, North Dakota, Forenede Stater, 58122
    - MeritCare Clinic at MeritCare Hospital
- Ohio
  - Akron, Ohio, Forenede Stater, 44307
    - Akron General Medical Center
  - Canton, Ohio, Forenede Stater, 44710
    - Aultman Health Foundation
  - Cincinnati, Ohio, Forenede Stater, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, Forenede Stater, 45220
    - Good Samaritan Hospital
  - Cincinnati, Ohio, Forenede Stater, 45220
    - Cardiovascular & Thoracic Surgeons
  - Cincinnati, Ohio, Forenede Stater, 45242
    - Cardiovascular & Thoracic Surgeons, Inc.
  - Columbus, Ohio, Forenede Stater, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, Forenede Stater, 43210
    - The Ohio State University Medical Center
  - Kettering, Ohio, Forenede Stater, 45429
    - Kettering Medical Center Network, Kettering Hospital
  - Toledo, Ohio, Forenede Stater, 43608
    - St. Vincent Mercy Medical Center
- Pennsylvania
  - Bethlehem, Pennsylvania, Forenede Stater, 18015
    - St. Luke's Hospital
  - Hershey, Pennsylvania, Forenede Stater, 17033
    - Penn State Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - Hospital of the University of Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - Presbyterian Hospital, University of Pennsylvania Health System
  - Pittsburgh, Pennsylvania, Forenede Stater, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, Forenede Stater, 15213
    - University of Pittsburgh Medical Center, Presbyterian Hospital
  - Sayre, Pennsylvania, Forenede Stater, 18840
    - Robert Packer Hospital
  - Sayre, Pennsylvania, Forenede Stater, 18840
    - Guthrie Clinic
  - West Chester, Pennsylvania, Forenede Stater, 19380
    - The Chester County Hospital
  - Wynnewood, Pennsylvania, Forenede Stater, 19096
    - Lankenau Hospital
- South Carolina
  - Greenville, South Carolina, Forenede Stater, 29605
    - Greenville Hospital System
  - Greenville, South Carolina, Forenede Stater, 29605
    - Upstate Cardiothoracic Surgery, Greenville Hospital System
- Tennessee
  - Memphis, Tennessee, Forenede Stater, 38119
    - Saint Francis Hospital
- Texas
  - Austin, Texas, Forenede Stater, 78756
    - Heart Hospital of Austin
  - Dallas, Texas, Forenede Stater, 75230
    - Medical City Dallas Hospital
  - Dallas, Texas, Forenede Stater, 75231
    - Presbyterian Hospital of Dallas
  - Dallas, Texas, Forenede Stater, 75235
    - St. Paul University Hospital
  - Denton, Texas, Forenede Stater, 76210
    - Denton Regional Medical Center
  - Plano, Texas, Forenede Stater, 75075
    - Medical Center Plano
  - San Antonio, Texas, Forenede Stater, 78229
    - Southwest Texas Methodist Hospital
  - San Antonio, Texas, Forenede Stater, 78233
    - Northeast Methodist Hospital
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84132
    - University of Utah Health Sciences Center
- Virginia
  - Lynchburg, Virginia, Forenede Stater, 24501
    - Lynchburg General Hospital
  - Norfolk, Virginia, Forenede Stater, 23507
    - Sentara Norfolk General Hospital
  - Norfolk, Virginia, Forenede Stater, 23510
    - Mid-Atlantic Cardiothoracic Surgeons, Ltd.
- Washington
  - Bellingham, Washington, Forenede Stater, 98225
    - St. Joseph Hospital
  - Spokane, Washington, Forenede Stater, 99204
    - Deaconess Medical Center
  - Spokane, Washington, Forenede Stater, 99204
    - Northwest Heart and Lung Surgical Associates
- West Virginia
  - Charleston, West Virginia, Forenede Stater, 25304
    - Charleston Area Medical Center
  - Charleston, West Virginia, Forenede Stater, 25304
    - CAMC Health Education and Research Institute, Clinical Trials Center
- Wisconsin
  - Appleton, Wisconsin, Forenede Stater, 54911
    - Appleton Heart Institute at Appleton Medical Center
  - Milwaukee, Wisconsin, Forenede Stater, 53215
    - St. Luke's Medical Center
  - Waukesha, Wisconsin, Forenede Stater, 53188
    - Waukesha Memorial Hospital
  - Wausau, Wisconsin, Forenede Stater, 54401
    - Wausau Heart and Lung Surgeons
  - Wausau, Wisconsin, Forenede Stater, 54401
    - Community Health Care/Wausau Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Dobbelt

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Anesiva, Inc.

Efterforskere

Studieleder: Todd Lorenz, M.D., Anesiva, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2002

Studieafslutning

1. februar 2005

Datoer for studieregistrering

Først indsendt

22. juli 2002

Først indsendt, der opfyldte QC-kriterier

23. juli 2002

Først opslået (Skøn)

24. juli 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. maj 2006

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2006

Sidst verificeret

1. juli 2005

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CGT003-04

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .