- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00584714
Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent
1. juli 2008 opdateret af: Point Biomedical
Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent
The purpose of this study is to collect longer term follow-up information concerning health and survival on selected patients who received PB127 for injectable suspension in the pivotal trial (127-014).
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Tucson, Arizona, Forenede Stater, 85724
- University of Arizona Saver Heart Clinic
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California
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Burlingame, California, Forenede Stater, 94010
- Cardiovascular Associates of the Peninsula
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Long Beach, California, Forenede Stater, 90822
- Long Beach VA Medical Center Cardiology Division
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Los Angeles, California, Forenede Stater, 90048
- Cedars Sinai Medical Center Division of Cardiology
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Roseville, California, Forenede Stater, 95661
- Sutter Roseville Medical Center
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San Diego, California, Forenede Stater, 92103
- University of California San Diego Division of Cardiology
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San Francisco, California, Forenede Stater, 94121
- San Francisco VA Medical Center NCIRE
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Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06606
- Connecticut Clinical Research
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- Alfieri Cardiology
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
- Washington Hospital Center Cardiovascular Research Institute
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University Feinberg School of Medicine
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Kansas
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Overland Park, Kansas, Forenede Stater, 66209
- Midwest Cardiology Associates
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Shawnee Mission, Kansas, Forenede Stater, 66204
- The Center for Cardiovascular Studies Kramer & Crouse Cardiology
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Kentucky
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Paducah, Kentucky, Forenede Stater, 42001
- Western Baptist Hospital The Heart Group
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Maine
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Auburn, Maine, Forenede Stater, 04210
- Androscoggin Cardiovascular Associates
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South Portland, Maine, Forenede Stater, 04106
- Maine Cardiology Associates
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Brigham & Women's Hosptial
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Michigan
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Detroit, Michigan, Forenede Stater
- Henry Ford Hospital
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Department of Cardiology
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Missouri
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Kansas City, Missouri, Forenede Stater, 64111
- Cardiovascular Consultants
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St. Louis, Missouri, Forenede Stater, 63110
- St. Louis University Medical Center
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New York
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Manhasset, New York, Forenede Stater, 11030
- North Shore University Hospital
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New York, New York, Forenede Stater, 10025
- St. Luke's Roosevelt Hospital Echocardiography Lab
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Stonybrook, New York, Forenede Stater, 11794
- Stonybrook University Medical Center
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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High Point, North Carolina, Forenede Stater, 27262
- Carolina Cardiology Associates
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- The Cleveland Clinic Foundation Department of Cardiology
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University College of Medicine and Public Health
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Cardiovascular Institute
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Texas
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Austin, Texas, Forenede Stater, 78705
- Austin Heart
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Austin, Texas, Forenede Stater, 78701
- Seton Healthcare Network Brackenridge Hospital
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Fort Worth, Texas, Forenede Stater, 76104
- Consultants in Cardiology
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Galveston, Texas, Forenede Stater, 77555
- University of Texas Division of Cardiology
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Houston, Texas, Forenede Stater, 77030
- Methodist DeBakery Heart Center Cardiovascular Imaging Institute
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Houston, Texas, Forenede Stater, 77030
- University of Texas Health Science Center Memorial Hermann Heart & Vascular Institute
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Harborview Medical Center Department of Cardiology
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Spokane, Washington, Forenede Stater, 99204
- Heart Clinics Northwest
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Spokane, Washington, Forenede Stater, 99204
- Northwest Cardiovascular Research Institute Spokane Cardiology
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Spokane, Washington, Forenede Stater, 99204
- Inland Cardiology
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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
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects with low/very low pre-test probability of coronary artery disease enrolled in Protocol 127-014 who did not have or were not schedule to undergo coronary angiography at the time of enrollment and did not have a clinical outcome during the initial 6 month follow-up period.
Beskrivelse
Inclusion Criteria:
Patients enrolled in Protocol 127-014 who
- Were enrolled in Stratum 1
- Did not undergo angiography during study evaluation
- Did not have a clinical oucome during the initial 6 month follow-up period as described in Protocol 127-014.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Alexander Ehlgen, MD, PhD, POINT Biomedical Corp.
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. oktober 2007
Primær færdiggørelse (Faktiske)
1. juli 2008
Studieafslutning (Faktiske)
1. juli 2008
Datoer for studieregistrering
Først indsendt
20. december 2007
Først indsendt, der opfyldte QC-kriterier
20. december 2007
Først opslået (Skøn)
2. januar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. juli 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2008
Sidst verificeret
1. juli 2008
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 127-014-A
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 .
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