- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00091637
Pexelizumab i forbindelse med angioplastik ved akut myokardieinfarkt (APEX-AMI)
17. november 2023 opdateret af: Procter and Gamble
APEX-AMI - Pexelizumab i forbindelse med angioplastik
I forbindelse med reperfusionsterapi i et akut myokardieinfarkt ved hjælp af primær perkutan intervention (PCI), kan kroppens eget inflammatoriske system, der involverer komplementkaskaden, være skadeligt.
Denne undersøgelse vil teste sikkerheden og effektiviteten af en ny komplementhæmmer, pexelizumab, til at reducere dødeligheden efter 30 dage.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
5745
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Australian Capital Territory
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Garran, Australian Capital Territory, Australien, 2605
- Canberra Hospital
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New South Wales
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Concord, New South Wales, Australien, 2137
- Concord Hospital
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Gosford, New South Wales, Australien, 2250
- Gosford Hospital
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Kogarah, New South Wales, Australien, 2217
- St. George Hospital
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Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital
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Randwick, New South Wales, Australien, 2031
- Prince of Wales Hospital
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St. Leonards, New South Wales, Australien, 2065
- Royal North Shore Hospital
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Queensland
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Chermside, Queensland, Australien, 4032
- Prince Charles Hospital
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Douglas, Queensland, Australien, 4814
- Townsville Hospital
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Wooloong Abba, Queensland, Australien, 4102
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital
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Bedford Park, South Australia, Australien, 5042
- Flinders Medical Centre
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Woodville South, South Australia, Australien, 5011
- The Queen Elizabeth Hospital
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Victoria
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Box Hill, Victoria, Australien, 3128
- Box Hill Hospital
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Box Hill, Victoria, Australien, 3084
- Austin Hospital
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Clayton, Victoria, Australien, 3162
- Monash Medical Centre
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Parkville, Victoria, Australien, 3050
- Royal Melbourne Hospital
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Richmond, Victoria, Australien, 3121
- Victorian Heart Clinic
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Western Australia
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Fremantle, Western Australia, Australien, 6160
- Fremantle Hospital
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Nedlands, Western Australia, Australien, 6009
- Sir Charles Gairdner Hospital
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Perth, Western Australia, Australien, 6000
- Royal Perth Hospital
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Antwerpen, Belgien, 2020
- Az Middelheim
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Liege, Belgien, 4000
- CHR de la Citadelle
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Brabant
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Leuven, Brabant, Belgien, 3000
- U.Z. Gasthuisberg
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Limburg
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Genk, Limburg, Belgien, 3600
- ZOL Campus Sint-Jan
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Vlaanderen
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Roeselare, Vlaanderen, Belgien, 8800
- Helig Hartziekenhuis
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-
-
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Alberta
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Calgary, Alberta, Canada, T2N 2W8
- Foothills Medical Centre
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St. Paul's Hospital
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Vancouver, British Columbia, Canada, V5Z 1L8
- Vancouver General Hospital
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Victoria, British Columbia, Canada, V8R 4R2
- Royal Jubilee Hospital
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital - New Brunswick Heart Centre
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3E4
- General Hospital Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
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Mississauga, Ontario, Canada, L58 2P7
- Trillium Health Center
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook & Women's Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H4J 1C5
- Hôpital Sacré-Coeur de Montréal
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Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute/Research Centre
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Montreal, Quebec, Canada, H2L 4M1
- Centre Hospitale de'Universite de Montreal (Pav Notre-Dame)_
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Sainte-Foy, Quebec, Canada, G1V 4G5
- Quebec Heart Institute/Laval Hospital
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke
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-
Saskatchewan
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Regina, Saskatchewan, Canada, S4P 0W5
- Regina General Hospital
-
-
-
-
-
Odense, Danmark, 5000
- Odense Universitets Hospital
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-
Danmark
-
Aalborg, Danmark, Danmark, 9100
- Aalborg Sygehus
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Aarhus, Danmark, Danmark, 8200
- Skejby Sygehus
-
Hellerup, Danmark, Danmark, 2900
- Amtssygehuset i Gentofte
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Kobenhavn, Danmark, Danmark, DK-2100
- Rigshospitalet
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-
-
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Alabama
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Huntsville, Alabama, Forenede Stater, 35801
- Huntsville Hospital
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic Hospital
-
Phoenix, Arizona, Forenede Stater
- North Phoenix Heart Center
-
Tucson, Arizona, Forenede Stater, 85741
- Northwest Medical Center
-
-
Arkansas
-
Fort Smith, Arkansas, Forenede Stater, 72901
- Sparks Regional Medical Center
-
Little Rock, Arkansas, Forenede Stater, 72211
- Arkansas State Hospital
-
-
California
-
Beverly Hills, California, Forenede Stater, 90230
- Brotman Medical Center
-
Burbank, California, Forenede Stater, 91505
- Providence Saint Joseph Medical Center
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Escondido, California, Forenede Stater, 92025
- Palomar Medical Center
-
Los Angeles, California, Forenede Stater, 90033
- Los Angeles Community Hospital
-
Modesto, California, Forenede Stater, 48201
- Memorial Medical Center
-
Sacramento, California, Forenede Stater, 95825
- Sutter Memorial Hospital
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San Diego, California, Forenede Stater, 92103-8784
- University of CA, San Diego Medical
-
Santa Rosa, California, Forenede Stater, 95403
- Sutter Medical Center of Santa Rosa
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Valencia, California, Forenede Stater, 91355
- Providence Holy Cross Medical Center
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80262
- University Of Colorado Hospital
-
-
Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06606
- St. Vincent Medical Center
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Farmington, Connecticut, Forenede Stater, 06030-2202
- University of Connecticut Health Center
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New Haven, Connecticut, Forenede Stater, 06520
- Yale - New Haven
-
-
District of Columbia
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Washington, District of Columbia, Forenede Stater, 20037
- George Washington University Hospital
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Florida
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Atlantis, Florida, Forenede Stater, 33462
- JFK Medical Center
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Clearwater, Florida, Forenede Stater, 33756
- Morton Plant Hospital
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Fort Lauderdale, Florida, Forenede Stater, 33308
- North Ridge Medical Center
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Jacksonville, Florida, Forenede Stater, 32224
- St. Luke's Hospital
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Melbourne, Florida, Forenede Stater, 32001
- Health First Holmes Regional Medical Center
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Orlando, Florida, Forenede Stater, 32803
- Florida Heart Hospital
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Sarasota, Florida, Forenede Stater, 34239
- Sarasota Memorial Hospital
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Tampa, Florida, Forenede Stater, 33613
- University Community Hospital
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Idaho
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Boise, Idaho, Forenede Stater, 63704
- St. Luke's Regional Medical Center
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Illinois
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Bannockburn, Illinois, Forenede Stater, 60015
- Highland Park Hospital
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Harvey, Illinois, Forenede Stater, 80426
- Ingalls Hospital
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Lombard, Illinois, Forenede Stater, 60148
- Advocate Good Samaritan
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Lombard, Illinois, Forenede Stater, 60148
- Elmhurst Hospital
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Moline, Illinois, Forenede Stater, 61265
- Trinity Medical Center
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Peoria, Illinois, Forenede Stater, 61603
- Saint Francis Medical Center
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Rock Island, Illinois, Forenede Stater, 61201
- Trinity Medical Center
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Methodist Hospital
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Indianapolis, Indiana, Forenede Stater, 46227
- Community Hospital South
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Indianapolis, Indiana, Forenede Stater, 46202
- VAMC
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Indianapolis, Indiana, Forenede Stater, 56250
- The Indiana Heart Hospital
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Munster, Indiana, Forenede Stater, 46321
- Munster Community Hospital
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Iowa
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Des Moines, Iowa, Forenede Stater, 50314
- Iowa Heart
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-
Kansas
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Wichita, Kansas, Forenede Stater, 67214
- Via Christi Reginal Medical Center
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-
Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
- Central Baptist Hospital
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Lexington, Kentucky, Forenede Stater, 40536-0200
- University of Kentucky
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Louisville, Kentucky, Forenede Stater, 40207
- Baptist Hospital East
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Louisville, Kentucky, Forenede Stater, 40202
- The Jewish Hospital
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Louisiana
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Chalmette, Louisiana, Forenede Stater, 70043
- Lousiana Heart Center
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Lacombe, Louisiana, Forenede Stater, 70445
- Lousiana Heart Hospital
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University Hospital and Clinic
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New Orleans, Louisiana, Forenede Stater, 70112
- MCLNO at New Orleans University Campus
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Eastern Maine Medical Center
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Portland, Maine, Forenede Stater, 04102
- Maine Medical Center
-
-
Maryland
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Towson, Maryland, Forenede Stater, 21204
- St. Joseph Medical Center
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-
Michigan
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Dearborn, Michigan, Forenede Stater, 48123
- Oakwood Hospital and Medical Center
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48235
- Sinai-Grace Hospital
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Grand Rapids, Michigan, Forenede Stater, 49503
- Spectrum Health
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Kalamazoo, Michigan, Forenede Stater, 49048
- Borgess Medical Center
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Muskegon, Michigan, Forenede Stater, 49444
- Mercy General Health Partners
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Petoskey, Michigan, Forenede Stater, 49770
- Northern Michigan Hospital
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Pontiac, Michigan, Forenede Stater, 48341-2982
- St. Joseph Mercy-Oakland
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital
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Saginaw, Michigan, Forenede Stater, 48601
- Covenant Medical Center
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Saginaw, Michigan, Forenede Stater, 48601
- Saint Mary Medical Center
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Southfield, Michigan, Forenede Stater, 48075
- Providence Hospital
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Troy, Michigan, Forenede Stater, 48085
- William Beaumont Hospital
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Warren, Michigan, Forenede Stater, 48201
- Harper University Hospital
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Minnesota
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
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Duluth, Minnesota, Forenede Stater, 55805
- St. Mary's Duluth Clinic Health System
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott Northwestern Hospital
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Minneapolis, Minnesota, Forenede Stater, 55422
- North Memorial Medical Center
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Rochester, Minnesota, Forenede Stater, 55902
- Saint Mary Hospital
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Saint Cloud, Minnesota, Forenede Stater, 56303
- St. Cloud Hospital
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Saint Louis Park, Minnesota, Forenede Stater, 55426
- Methodist Hospital
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Saint Paul, Minnesota, Forenede Stater, 55102
- Health East St. Joseph Hospital
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Missouri
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Columbia, Missouri, Forenede Stater, 65212
- University of Missouri Health Sciences Center
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Saint Louis, Missouri, Forenede Stater, 63110
- St. Louis University Hospital
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Saint Louis, Missouri, Forenede Stater, 63122
- Barnes St. Peters Hospital
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Springfield, Missouri, Forenede Stater, 65807
- St. John's Hospital
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Montana
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Billings, Montana, Forenede Stater, 59101
- Deaconess Billings Clinic
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68510
- St. Elizabeth Medical Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109
- Sunrise Hospital
-
-
New Jersey
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Elizabeth, New Jersey, Forenede Stater, 07202
- Trinitas Hospital
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Fair Lawn, New Jersey, Forenede Stater, 07410
- St. Joseph's Regional Medical Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- New Mexico Heart Institute
-
-
New York
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Albany, New York, Forenede Stater, 12211
- Albany Medical Center
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Bronx, New York, Forenede Stater, 10467
- Monteflore Medical Center
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Brooklyn, New York, Forenede Stater, 11219
- Maimonides Medical Center
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Johnson City, New York, Forenede Stater, 13790
- Wilson Memorial Medical Center
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Mineola, New York, Forenede Stater, 11504
- Winthrop University Hospital
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New York, New York, Forenede Stater, 10016
- Bellevue Hospital Center
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New York, New York, Forenede Stater, 10011
- St. Vincent's Catholic Medical Center
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Poughkeepsie, New York, Forenede Stater, 12601
- Vassar Brothers Medical Center
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Rochester, New York, Forenede Stater, 14621
- Rochester General Hospital
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Syracuse, New York, Forenede Stater, 13210
- SUNY - Upstate Medical University
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Presbyterian Hospital
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Durham, North Carolina, Forenede Stater, 27705
- Duke University Health Systems
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Greensboro, North Carolina, Forenede Stater, 27401
- Moses Cone Hospital/LeBauer Healthcare
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Greenville, North Carolina, Forenede Stater, 27834
- Pitt County Memorial Hospital
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High Point, North Carolina, Forenede Stater, 27262
- High Point Regional Health System
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North Dakota
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Minot, North Dakota, Forenede Stater, 58701
- Trinity Hospital
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Ohio
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Akron, Ohio, Forenede Stater, 44307
- Akron General Medical Center
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Cincinnati, Ohio, Forenede Stater, 45242
- Bethesda North Hospital
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Cincinnati, Ohio, Forenede Stater, 45220
- VAMC Cincinnati
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Cincinnati, Ohio, Forenede Stater, 45267
- The University Hospital
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, Forenede Stater, 44103
- University Hospitals of Cleveland
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Columbus, Ohio, Forenede Stater, 43214
- MidWest Cardiology Research Foundation
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Mansfield, Ohio, Forenede Stater, 44906
- Med Central Mansfield
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Zanesville, Ohio, Forenede Stater, 43701
- Genesis HealthCare System
-
-
Oklahoma
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Midwest City, Oklahoma, Forenede Stater, 73110
- Midwest Regional Medical Center
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Forenede Stater, 73120
- Oklahoma Heart Hospital
-
Oklahoma City, Oklahoma, Forenede Stater, 73112
- INTEGRIS Baptist Medical Center, Inc.
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- VA Medical Center
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-
Oregon
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Bend, Oregon, Forenede Stater, 97701
- St. Charles Medical Center
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Portland, Oregon, Forenede Stater, 97213
- Providence Portland Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18105
- LeHigh Valley Hospital
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Danville, Pennsylvania, Forenede Stater, 17822-2160
- Geisinger Medical Center
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Davenport, Pennsylvania, Forenede Stater, 58803
- Genesis Medical Center
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Erie, Pennsylvania, Forenede Stater, 16550
- Hamot Medical Center
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Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State Milton S. Hershey Medical Center
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Lancaster, Pennsylvania, Forenede Stater, 17604
- Lancaster General Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Hospital of the University of Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19140
- Temple University Hospital
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny General Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15240
- VA Pittsburgh Healthcare System
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Pittsburgh, Pennsylvania, Forenede Stater, 15025
- Jefferson Regional Medical Center
-
Pittsburgh, Pennsylvania, Forenede Stater, 15215
- Western Pennsylvania Hospital
-
West Chester, Pennsylvania, Forenede Stater, 19380
- The Chester County Hospital
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York, Pennsylvania, Forenede Stater, 17405
- York Hospital
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-
Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
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-
South Carolina
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Columbia, South Carolina, Forenede Stater, 29203
- Palmetto Richland Memorial Hospital
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Columbia, South Carolina, Forenede Stater, 29204
- Sisters of Charity Providence Hospitals
-
-
South Dakota
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Rapid City, South Dakota, Forenede Stater, 57719
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Forenede Stater, 57108
- Heart Hospital of South Dakota
-
-
Tennessee
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Jackson, Tennessee, Forenede Stater, 38301
- Jackson-Madison County General Hospital
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Kingsport, Tennessee, Forenede Stater, 37660
- Wellmont Holston Valley Medical Center
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Knoxville, Tennessee, Forenede Stater, 37920
- Baptist Hospital of East Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37916
- Fort Sanders Rgional Medical Center
-
Nashville, Tennessee, Forenede Stater, 37203
- Centennial Medical Center
-
Oak Ridge, Tennessee, Forenede Stater, 37830
- Methodist Medical Center
-
-
Texas
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Amarillo, Texas, Forenede Stater, 79106
- Northwest Texas Healthcare System
-
Austin, Texas, Forenede Stater, 78705
- Seton Medical Center
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Dallas, Texas, Forenede Stater, 75230
- Medical City Dallas
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Dallas, Texas, Forenede Stater, 75390
- Parkland Health & Hospital System
-
Dallas, Texas, Forenede Stater, 57231
- Presbyterian Hospital of Dallas
-
Dallas, Texas, Forenede Stater, 75390
- Dallas Medical Center
-
Fort Sam Houston, Texas, Forenede Stater, 78234
- Brooke Army Medical Center
-
Houston, Texas, Forenede Stater, 77030
- Michael E. DeBakey VA Medical Center
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Houston, Texas, Forenede Stater, 77030
- Memorial Hermann Hospital
-
Houston, Texas, Forenede Stater, 77030
- Ben Taub General Hospital
-
Houston, Texas, Forenede Stater, 77090
- Houston Northwest Medical Center
-
Lubbock, Texas, Forenede Stater, 79410
- Covenant Medical Center
-
San Antonio, Texas, Forenede Stater, 78217
- Northeast Baptist Hospital
-
San Antonio, Texas, Forenede Stater, 78258
- South Texas Veterans Health Care System Audie L. Murphy Division
-
Temple, Texas, Forenede Stater, 76508
- Scott & White Memorial Hospital
-
Tyler, Texas, Forenede Stater, 75701
- East Texas Medical Center
-
Tyler, Texas, Forenede Stater, 75701
- Trinity Mother Frances Hospital
-
Victoria, Texas, Forenede Stater, 77901
- Citizens Medical Center
-
Victoria, Texas, Forenede Stater, 77901
- Detar Hospital
-
-
Utah
-
Murray, Utah, Forenede Stater, 84107
- Cottonwood Hospital
-
-
Virginia
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Alexandria, Virginia, Forenede Stater, 22306
- Inova Alexandria Hospital
-
Charlottesville, Virginia, Forenede Stater, 22908
- Universitiy of Virginia Health Science Center
-
Harrisonburg, Virginia, Forenede Stater, 22801
- Rockingham Memorial Hospital
-
Lynchburg, Virginia, Forenede Stater, 24501
- Lynchburg General Hospital
-
Richmond, Virginia, Forenede Stater
- Herrico Doctors' Hospital - Forest
-
Virginia Beach, Virginia, Forenede Stater, 23454
- Sentara Virginia Beach General Hospital
-
Winchester, Virginia, Forenede Stater, 22601
- Winchester Medical Center
-
-
Washington
-
Bellevue, Washington, Forenede Stater, 98004
- Overtake Hospital Medical Center
-
Mount Vernon, Washington, Forenede Stater, 98274
- Skagit Valley Hospital
-
Seattle, Washington, Forenede Stater, 98104
- Harborview Medical Center
-
Tacoma, Washington, Forenede Stater, 98405
- MultiCare Medical Center (Tacoma General Hospital)
-
Tacoma, Washington, Forenede Stater, 98405
- St. Joseph Medical Center
-
-
West Virginia
-
Morgantown, West Virginia, Forenede Stater, 26506-9157
- West Virginia University Hospital
-
-
Wisconsin
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La Crosse, Wisconsin, Forenede Stater, 54601
- Franciscan Skemp Healthcare
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Froedtert Hospital
-
Waukesha, Wisconsin, Forenede Stater, 53188
- Waukesha Memorial Hospital
-
-
-
-
-
Angers, Frankrig, 49100
- CHRU de Angers
-
Colmar Cedex, Frankrig, 66027
- Clinique Saint Joseph
-
Eaubonne-Montmorency, Frankrig, 95601
- Cardiologie Hopital Simone Veil
-
Haguenau, Frankrig, 67504
- Centre Hospitalier de Haguenau
-
Nantes, Frankrig, 44000
- CHRU de Nantes
-
Paris, Frankrig, 75010
- Hôpital Lariboisière
-
Paris, Frankrig, 75018
- Hôpital Bichat
-
Paris Cedex 13, Frankrig, 75743
- Hopital a Pitie Salpetriere
-
Pessac, Frankrig, 33604
- Hôpital du Haut Lévêque
-
Rennes, Frankrig, 35000
- Hôpital Pontchaillou
-
Rouen, Frankrig, 76000
- CHRU de Rouen
-
Saint Denis, Frankrig, 93200
- Centre Cardiologique du Nord
-
Strasbourg, Frankrig, 67100
- CHRU Hautepierre
-
Toulouse Cedex 9, Frankrig, 31059
- Hopital Rangueil
-
Vandoeuvre les Nancy, Frankrig, 54511
- Hopital d'adultes de Brabois (CHU de Nancy)
-
-
-
-
BR
-
Eindhovenb, BR, Holland, 5623 EJ
- Catharina Hospital
-
-
LI
-
Maastricht, LI, Holland, 6229 HX
- Academic Hospital Maastricht
-
-
NH
-
Alkmaar, NH, Holland, 1800 AM
- Medeisch Centrum Alkmaar
-
Amsterdam, NH, Holland, 1081 HV
- VUMC
-
Amsterdam, NH, Holland, 1091 HD
- OLVG
-
-
OV
-
Zwolle, OV, Holland, 8011 JW
- Isla Klinieken Location De Weezenlanden
-
-
UT
-
Nieuwegein, UT, Holland, 3435 CM
- Sint Antonius Hospital
-
Ultrecht, UT, Holland, 3584 CX
- University Medical Center Utrecht
-
-
ZH
-
Rotterdam, ZH, Holland, 3015 GD
- Erasmus Medical Centre
-
Rotterdam, ZH, Holland, 3075 EA
- Medisch Centrum Rijnmond-Zuid
-
-
-
-
-
Alessandria, Italien, 15100
- A.O. SS. Antonio e Biagio e Cesare Arrigo
-
Bologna, Italien, 40128
- Policlinico Sant'Orsola-Malpighi
-
Bolzano, Italien, 39100
- Ospedale Centrale di Bolzano
-
Brescia, Italien, 25123
- A.O. Spedali di Civili
-
Como, Italien, 22100
- A.O. della Regione Lombardia Presidio Ospedaliero Sant'Anna
-
Lecco, Italien, 23900
- Ospedale Alessandro Manzoni
-
Mantova, Italien, 46100
- Azienda Ospedaliera Carlo Poma
-
Parma, Italien, 43100
- Azienda Ospedaliera di Parma - Ospedale Maggiore
-
Pavia, Italien, 27100
- Policlinico San Matteo - I.R.C.C.S.
-
Pesaro, Italien, 46100
- A. O. S. Salvatore
-
Rimni, Italien, 47900
- Osepdale degli Intermi
-
Roma, Italien, 00152
- AO S. Camillo Forlanini
-
Torino, Italien, 10126
- Cardiologia Universitaria
-
Treviso, Italien, 31100
- Ospedale S. Maria di Ca'Foncello
-
-
Milano
-
San Donato Milanese, Milano, Italien, 20097
- Centro E Malan
-
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Padova
-
Cittadella, Padova, Italien, 35013
- Presidio Ospedaliero di Cittadella
-
-
Reggio Emilla
-
Reggio Nell Emilia, Reggio Emilla, Italien, 42100
- U.O. Cardiologia
-
-
-
-
-
Auckland, New Zealand, 1003
- Auckland City Hospital
-
Wellington, New Zealand, 6002
- Wellington Hospital
-
-
Canterbury
-
Christchurch, Canterbury, New Zealand, 8001
- Christchurch Hospital
-
-
Otago
-
Dunedin, Otago, New Zealand, 9001
- Dunedin Hospital
-
-
Waikoto
-
Hamilton, Waikoto, New Zealand, 2001
- Waikato Hospital
-
-
-
-
-
Katowice - Ochojec, Polen, 40-635
- I Klinika Kardiologii
-
Krakow, Polen, 31-202
- Klinika Chorob Serca i Naczyn
-
Lodz, Polen, 91-347
- II Katedra i Klinika Kardiologii
-
Warszawa, Polen, 04-628
- I Klinika Choroby Wiencowej
-
Wroclaw, Polen, 50-420
- SPZOZ Dolnoslaski Szpital Specjalistyczny
-
-
-
-
-
Amadora, Portugal, 3700-376 Amadora
- H. Fernando da Fonesca
-
Coimbra, Portugal, 3000-075 Coimbra
- Hospitals da Universidade de Coimbra
-
Lisboa, Portugal, 1069-166 Lisboa
- Hospital Curry Cabral
-
Lisboa, Portugal, 1600-190 LISBOA
- H. Santa Maria
-
Porto, Portugal, 4200-319 Porto
- Hospital Sao Joao - Servico de Cardiologia
-
Vila Nova De Gala, Portugal, 4434-502 Vila Nova de Gala
- Centro Hospitalar de Vila Nova de Gala
-
-
Lisboa
-
Almada, Lisboa, Portugal, 2801-951 Almada
- Hospital Garcia de Orta - Servico de Cardiologia
-
Carnaxide, Lisboa, Portugal, 270-134
- Hospital Santa Cruz
-
-
-
-
-
Bassel, Schweiz, 4031
- Kantonsspital Basel
-
-
Geneva
-
Geneva 14, Geneva, Schweiz, CH-1211
- University Hospital of Geneva
-
-
Saint Gallen
-
St. Gallen, Saint Gallen, Schweiz, CH-9007
- Kantonsspital St. Gallen
-
-
Thurgau
-
Kreuzlingen, Thurgau, Schweiz, 8280
- Herzklinik Bodensee am Weinberg AG
-
-
Ticino
-
Lugano, Ticino, Schweiz, 6900
- Cardiocentro Ticino
-
-
-
-
-
Alicante, Spanien, 03010
- Hospital General Universitario de Alicante
-
Barcelona, Spanien, 08036
- Hospital Clinic I Provincial
-
Leon, Spanien, 24008
- Hospital de León
-
Madrid, Spanien, 28040
- Hospital Clinico San Carlos
-
Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Marañón
-
Madrid, Spanien, 28035
- Hospital Puerta de Hierro
-
Malaga, Spanien, 29010
- Hospital Clinico Universitario Virgen de La Victoria
-
Sevilla, Spanien, 41013
- Hopspital Virgen del Rocio
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Ciutat Sanitaria i Universitaria de Bellvitge
-
-
Murcia
-
El Palmar, Murcia, Spanien, 30120
- Hospital Virgen da la Arrixaca
-
-
Navarra
-
Pamplona, Navarra, Spanien, 31008
- Hospital de Navarra
-
-
-
-
-
Umea, Sverige, SE-901-85
- Universitetetssjukhuset Umea
-
Uppsala, Sverige
- Uppsala University Hospital
-
-
-
-
-
Brno, Tjekkiet, 625 00
- Interni kardiologicka klinika, Fakultni nemocnice Brno
-
Brno, Tjekkiet, 656 91
- I. interni kardioangiologicka klinika, Fakultni nemocnice u Sv. Anny
-
Liberec, Tjekkiet, 460 63
- Kardiologicke odd., Krajska neocnice Liberec
-
Olomouc, Tjekkiet, 775-20
- I. Interni klinika, FN Olomouc
-
Ostrava, Tjekkiet, 708 52
- Interni klinika, FNsP Ostrava
-
Pardubice, Tjekkiet, 532 03
- Kardio-Troll sro and Krajska nemocnice Pardubice
-
Pardubice, Tjekkiet, 53203
- Kardio-Troll sro and Krajska nemocnice Pardubice
-
Plzen, Tjekkiet, 304 60
- I. Interni klinika, Fakultni nemocnice Plzen
-
Prague, Tjekkiet, 10034
- Kardiocentrum, Fakultni nemocnice Kralovske Vinohrady
-
Prague, Tjekkiet, 128 08
- II. Interni klinika, Vseobecna fakultni nemocnice
-
Prague, Tjekkiet, 150 30
- Kardiologicke odd., Nemocnice Na Homoice
-
Prague, Tjekkiet, 15006
- Kardiologicka klinika FN v Motole
-
Trinec, Tjekkiet, 739 61
- Kardiocentrum, Nemocnice Podlesi sro
-
Zlin, Tjekkiet, 462 75
- Interni klinika, Batova nemocnice
-
-
Ceske Budejovice
-
Caske Budejovice, Ceske Budejovice, Tjekkiet, 370 878
- Kardiologicke odd. Nemocnice Ceske Budejovice as
-
-
Hradec Kralove
-
Kradec Kralove, Hradec Kralove, Tjekkiet, 500 05
- I. Interni klinika, Fakultni nemocnice Hradec
-
-
Prague
-
Prague 4, Prague, Tjekkiet, 14021
- Klinika kardiologie, IKEM
-
-
Usti Nad Labem
-
Labem, Usti Nad Labem, Tjekkiet, 401 13
- Kardiologicke oddeleni, Masarykova nemocnice
-
-
-
-
-
Bad Oeynhausen, Tyskland, 32545
- Universitätsklinik Der Ruhr-Universität Bochum
-
Berlin, Tyskland, 10967
- Vivantes Klinikum Am Urban
-
Berlin, Tyskland, 10249
- Vivantes Klinikkum im Friedrichshain
-
Hamburg, Tyskland, 20246
- Universitätsklinikum Hamburg-Eppendorf
-
Hamburg, Tyskland, 20099
- Allgemeines Krankenhaus St. Georg
-
-
Baden-Wurttemberg
-
Mannheim, Baden-Wurttemberg, Tyskland, 66167
- Universitätsklinikum Mannheim
-
-
Bavaria
-
Augsburg, Bavaria, Tyskland, 86156
- Klinikum Augsburg, Stenglinstr. 2.
-
Coburg, Bavaria, Tyskland, 96450
- Klinikum Coburg
-
Munchen, Bavaria, Tyskland, 81925
- Stadt Krankenhaus Muenchen-Bogenhausen
-
-
Hessen
-
Bad Nauheim, Hessen, Tyskland, 61231
- Kerckhoff-Klinik Bad Anuheim
-
Kassel, Hessen, Tyskland, 34125
- Stadt. Kliniken Kassel
-
-
Lower Saxony
-
Celle, Lower Saxony, Tyskland, 29223
- Allgemeines Krankenhaus Celle
-
Gottingen, Lower Saxony, Tyskland, 37075
- Herzzentrum Göttingen
-
-
Nordhein Westfalen
-
Dortmund, Nordhein Westfalen, Tyskland, 44137
- St. Johannes Krankenhaus
-
Duisburg, Nordhein Westfalen, Tyskland, 47137
- Herzzentrum Duisburg
-
-
Nordrhein Westfalen
-
Koln, Nordrhein Westfalen, Tyskland, 51109
- Kliniken der Stadt Koln
-
Wuppertal, Nordrhein Westfalen, Tyskland, 42117
- Helios Klinikum Wuppertal GmbH
-
-
North Rhine-Westphalia
-
Detmold, North Rhine-Westphalia, Tyskland, 32756
- Klinikkum Lippe
-
-
Rhineland-Palatinate
-
Ludwigshafen, Rhineland-Palatinate, Tyskland, 67063
- Klinikkum Ludwigshafen
-
-
Schleswig Holstein
-
Bad Segeberg, Schleswig Holstein, Tyskland, 23795
- Herzzentrum
-
-
Schleswig-Holstein
-
Lubeck, Schleswig-Holstein, Tyskland, 23538
- Universitatsklinik Lubeck
-
-
Thuringia
-
Jena, Thuringia, Tyskland, 07740
- Klinik fur Innere Medizin 1
-
-
Wurrtemberg
-
Krozingen, Wurrtemberg, Tyskland, 79189
- Herz-Zentrum Bad Krozingen
-
-
-
-
-
Linz, Østrig, 4010
- Krankenhaus der barmherzigen Schwestern
-
Wien, Østrig, 1090
- Univ. Klinik f. Innere Medizin II
-
Wien, Østrig, 1171
- Wilhelminenspital
-
-
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Hjertesymptomer i mindst 20 minutter inden for de sidste 6 timer;
- Vil gennemgå primær PCI;
- Har EKG-bevis for akut højrisiko ST-elevation myokardieinfarkt;
- Vil gerne og kan følges i mindst 12 måneder.
Ekskluderingskriterier:
- Isoleret lavrisiko inferior myokardieinfarkt;
- Modtaget fibrinolytisk terapi;
- Historie om komplementmangel;
- Mistænkt neisseriel infektion;
- Deltagelse i anden undersøgelse;
- Graviditet;
- Tidligere tilmelding.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: 1
Placebo infusion
|
bolusinfusion over en 10 minutters periode én gang
|
|
Eksperimentel: 2
Pexelizumab infusion
|
Pexelizumab (2 mg/kg) intravenøst, bolus i 10 minutter én gang
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Reduktion af alle dødsårsager
Tidsramme: dag 30
|
dag 30
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Thomas G Todaro, MD, JD, FACC, Procter and Gamble
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
- Bagai A, Armstrong PW, Stebbins A, Mahaffey KW, Hochman JS, Weaver WD, Patel MR, Granger CB, Lopes RD. Prognostic implications of left ventricular end-diastolic pressure during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Findings from the Assessment of Pexelizumab in Acute Myocardial Infarction study. Am Heart J. 2013 Nov;166(5):913-9. doi: 10.1016/j.ahj.2013.08.006. Epub 2013 Sep 24.
- Guptill JT, Mehta RH, Armstrong PW, Horton J, Laskowitz D, James S, Granger CB, Lopes RD. Stroke after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: timing, characteristics, and clinical outcomes. Circ Cardiovasc Interv. 2013 Apr;6(2):176-83. doi: 10.1161/CIRCINTERVENTIONS.112.000159. Epub 2013 Apr 2.
- Westerhout CM, Pieper KS, James SK, Mahaffey KW, de Werf FV, Califf RM, Granger CB, Armstrong PW. Dynamic modeling of 90-day mortality in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. Am Heart J. 2013 Mar;165(3):354-62.e2. doi: 10.1016/j.ahj.2012.12.001. Epub 2013 Jan 15.
- Patel MR, Westerhout CM, Granger CB, Brener SJ, Fu Y, Siha H, Kim RJ, Armstrong PW. Aborted myocardial infarction after primary percutaneous coronary intervention: magnetic resonance imaging insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2013 Feb;165(2):226-33. doi: 10.1016/j.ahj.2012.10.028. Epub 2012 Nov 24.
- Truffa AA, Granger CB, White KR, Newby LK, Mehta RH, Hochman JS, Patel MR, Pieper KS, Al-Khalidi HR, Armstrong PW, Lopes RD. Serious infection after acute myocardial infarction: incidence, clinical features, and outcomes. JACC Cardiovasc Interv. 2012 Jul;5(7):769-76. doi: 10.1016/j.jcin.2012.03.018.
- Martel C, Granger CB, Ghitescu M, Stebbins A, Fortier A, Armstrong PW, Bonnefoy A, Theroux P. Pexelizumab fails to inhibit assembly of the terminal complement complex in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Insight from a substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2012 Jul;164(1):43-51. doi: 10.1016/j.ahj.2012.04.007. Epub 2012 Jun 15.
- van Diepen S, Widimsky P, Lopes RD, White KR, Weaver WD, Van de Werf F, Ardissino D, van't Hof AW, Armstrong PW, Granger CB. Transfer times and outcomes in patients with ST-segment-elevation myocardial infarction undergoing interhospital transfer for primary percutaneous coronary intervention: APEX-AMI insights. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):437-44. doi: 10.1161/CIRCOUTCOMES.112.965160. Epub 2012 May 15.
- Hudson MP, Armstrong PW, O'Neil WW, Stebbins AL, Weaver WD, Widimsky P, Aylward PE, Ruzyllo W, Holmes D, Mahaffey KW, Granger CB. Mortality implications of primary percutaneous coronary intervention treatment delays: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):183-92. doi: 10.1161/CIRCOUTCOMES.110.945311. Epub 2011 Feb 8.
- Huber K, Holmes DR Jr, van 't Hof AW, Montalescot G, Aylward PE, Betriu GA, Widimsky P, Westerhout CM, Granger CB, Armstrong PW. Use of glycoprotein IIb/IIIa inhibitors in primary percutaneous coronary intervention: insights from the APEX-AMI trial. Eur Heart J. 2010 Jul;31(14):1708-16. doi: 10.1093/eurheartj/ehq143. Epub 2010 May 25.
- Alhadramy O, Westerhout CM, Brener SJ, Granger CB, Armstrong PW; APEX AMI Investigators. Is visual interpretation of coronary epicardial flow reliable in patients with ST-elevation myocardial infarction undergoing primary angioplasty? Insights from the angiographic substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2010 May;159(5):899-904. doi: 10.1016/j.ahj.2010.02.028.
- Patel MR, Worthley SG, Stebbins A, Dill T, Rademakers FE, Valeti US, Barsness GW, Van de Werf F, Hamm CW, Armstrong PW, Granger CB, Kim RJ. Pexelizumab and infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary Intervention: a delayed enhancement cardiac magnetic resonance substudy from the APEX-AMI trial. JACC Cardiovasc Imaging. 2010 Jan;3(1):52-60. doi: 10.1016/j.jcmg.2009.09.014. Epub 2010 Jan 12. Erratum In: JACC Cardiovasc Imaging. 2010 Jul;3(7):796. Velleti, Uma S [corrected to Valeti, Uma S].
- Trendelenburg M, Theroux P, Stebbins A, Granger C, Armstrong P, Pfisterer M. Influence of functional deficiency of complement mannose-binding lectin on outcome of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Eur Heart J. 2010 May;31(10):1181-7. doi: 10.1093/eurheartj/ehp597. Epub 2010 Jan 19.
- Brener SJ, Westerhout CM, Fu Y, Todaro TG, Moliterno DJ, Wagner GS, Granger CB, Armstrong PW; APEX-AMI Investigators. Contribution of angiographic and electrocardiographic parameters of reperfusion to prediction of mortality and morbidity after acute ST-elevation myocardial infarction: Insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Am Heart J. 2009 Nov;158(5):755-60. doi: 10.1016/j.ahj.2009.09.009. Epub 2009 Oct 3.
- Armstrong PW, Fu Y, Westerhout CM, Hudson MP, Mahaffey KW, White HD, Todaro TG, Adams PX, Aylward PE, Granger CB. Baseline Q-wave surpasses time from symptom onset as a prognostic marker in ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention. J Am Coll Cardiol. 2009 Apr 28;53(17):1503-9. doi: 10.1016/j.jacc.2009.01.046.
- Buller CE, Fu Y, Mahaffey KW, Todaro TG, Adams P, Westerhout CM, White HD, van 't Hof AW, Van de Werf FJ, Wagner GS, Granger CB, Armstrong PW. ST-segment recovery and outcome after primary percutaneous coronary intervention for ST-elevation myocardial infarction: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Circulation. 2008 Sep 23;118(13):1335-46. doi: 10.1161/CIRCULATIONAHA.108.767772. Epub 2008 Sep 8.
- APEX AMI Investigators; Armstrong PW, Granger CB, Adams PX, Hamm C, Holmes D Jr, O'Neill WW, Todaro TG, Vahanian A, Van de Werf F. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA. 2007 Jan 3;297(1):43-51. doi: 10.1001/jama.297.1.43.
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. april 2004
Primær færdiggørelse (Faktiske)
1. maj 2007
Studieafslutning (Faktiske)
1. maj 2007
Datoer for studieregistrering
Først indsendt
14. september 2004
Først indsendt, der opfyldte QC-kriterier
15. september 2004
Først opslået (Anslået)
16. september 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Anslået)
20. november 2023
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. november 2023
Sidst verificeret
1. november 2023
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2003056
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 .