Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures

4 maggio 2006 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Disfunsione dell'arteria coronaria

Intervento / Trattamento

Droga: CGT003 (esca duplex E2F)

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione

3000

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Prevenzione
Assegnazione: Randomizzato
Modello interventistico: Assegnazione di gruppo singolo
Mascheramento: Doppio

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Anesiva, Inc.

Investigatori

Direttore dello studio: Todd Lorenz, M.D., Anesiva, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2002

Completamento dello studio

1 febbraio 2005

Date di iscrizione allo studio

Primo inviato

22 luglio 2002

Primo inviato che soddisfa i criteri di controllo qualità

23 luglio 2002

Primo Inserito (Stima)

24 luglio 2002

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

5 maggio 2006

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2006

Ultimo verificato

1 luglio 2005

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

CGT003-04

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .