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Familiarization and Safety Study of PB127 Ultrasound Contrast Agent

1. juli 2008 opdateret af: Point Biomedical

A Familiarization and Safety Study of Myocardial Perfusion Contrast Echocardiography With PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease

The purpose of this study is to evaluate preparation and administration of PB127, echocardiographic images obtained during PB127 administration, and evaluate the safety of PB127.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary objectives of this clinical trial are:

  1. To train potential Phase 3 investigational sites in the preparation and andministration of PB127
  2. To train potential Phase 3 investigational sites in the acquisition of adequate images
  3. To collect additional safety information regarding intravenous administration of PB127
  4. To obtain a larger sample of images obtained with the Acuson Sequoia ultrasound system.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85018
        • Michael Morgan, MD
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic Scottsdale
      • Scottsdale, Arizona, Forenede Stater, 85258
        • Heartcare, P.C.
    • California
      • Long Beach, California, Forenede Stater, 90822
        • Long Beach VA Medical Center Cardiology Division
      • San Diego, California, Forenede Stater, 92103
        • University of California San Diego Division of Cardiology
      • San Francisco, California, Forenede Stater, 94143
        • University of California San Francisco
      • San Francisco, California, Forenede Stater, 94121
        • San Francisco VA Medical Center NCIRE
      • Stanford, California, Forenede Stater, 94305
        • Stanford University Medical Center
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Washington Hospital Center Cardiovascular Research Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Krannert Institute of Cardiology
    • Kansas
      • Shawnee Mission, Kansas, Forenede Stater, 66204
        • The Center for Cardiovascular Studies Kramer and Crouse Cardiology
    • Maine
      • Auburn, Maine, Forenede Stater, 04210
        • Androscoggin Cardiovascular Associates
      • South Portland, Maine, Forenede Stater, 04106
        • Maine Cardiology Associates
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • New England Medical Center
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Cardiovascular Consultants
      • St. Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • St. Louis, Missouri, Forenede Stater, 63110
        • St. Louis University Medical Center
    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Hospital
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, Forenede Stater, 43214
        • MidWest Cardiologist Research
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401
        • Endovascular Research, LLC
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Cardiovascular Institute
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Austin Heart
      • Dallas, Texas, Forenede Stater, 75216
        • Dallas VA Medical Center
      • Dallas, Texas, Forenede Stater, 75231
        • Presbyterian Hospital of Dallas
      • Houston, Texas, Forenede Stater, 77030
        • Methodist DeBakery Heart Center Cardiovascular Imaging Institute
      • San Antonio, Texas, Forenede Stater, 78229
        • University of Texas Health Sciences Center at San Antonio
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia Health System
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, Forenede Stater, 98104
        • Harborview Medical Center Department of Cardiology
      • Spokane, Washington, Forenede Stater, 99204
        • Northwest Cardiovascular Research Institute Spokane Cardiology
      • Spokane, Washington, Forenede Stater, 99204
        • Inland Cardiology

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

Beskrivelse

Inclusion Criteria:

  1. Able to provide written informed consent
  2. Scheduled for stress echocardiography, SPECT nuclear imaging and/or coronary angiography within the two weeks prior to or following Study Day 1
  3. Adequate visualization of all myocardial segments in at least one imaging plane during screening non-contrast echocardiogram

Exclusion Criteria:

  1. Women who were pregnant or lactating

  2. Known hypersensitivity or known contraindication to

    1. Dipyridamole
    2. Other ultrasound contrast agents
    3. Blood, blood products, albumin, egg, or protein
  3. Use of caffeine or xanthine containing products within the 24 hours prior to PB127 MPE
  4. Frequent (> 60/hour) or symptomatic ventricular ectopics at baseline
  5. Atrial fibrillation
  6. Permanent pacemaker or defibrillator

  7. History of:

    1. Complex ventricular arrhythmia
    2. Chronic hepatitis

    3. Liver disease characterized by one or more of the following:

      • current jaundice
      • elevated bilirubin > upper limit of normal
      • currently elevated hepatic enzymes > 2X upper limit of normal
      • current or previous hepatic viral infection
    4. Chronic obstructive pulmonary disease (COPD) that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole
    5. Bronchospastic airway disease that, in the opinion of the Investigator, was significant enough to contraindicate dipyridamole
    6. Coronary artery bypass graft (CABG) within the 7 days prior to Study Day 1
    7. Heart transplant
    8. Q wave myocardial infarction within the 7 days prior to Study Day 1
    9. Cardiac intervention or surgery within the 7 days prior to Study Day 1
  8. Hypertension (systolic blood pressure [SBP] >200 mmHg and diastolic blood pressure [DBP] >110 mmHg)
  9. Hypotension (SBP <90 mmHg) documented within the 24 hours prior to Study Day 1

  10. Significant valvular disease

    1. Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
    2. Severe mitral regurgitation (usual clinical criteria plus or minus any of the following: proximal isovelocity surface area [PISA] >1 cm2, forward transmitral gradient of >2 m/sec, unexplained systolic flow reversal or blunting in the pulmonary veins)
    3. Severe mitral stenosis (<1.0 cm2 estimated valve area)
  11. Congestive heart failure (New York Heart Association [NYHA] Class IV); NYHA classes are defined in Appendix D of the protocol (see Appendix 16.1.1)
  12. Pulmonary edema within the 7 days prior to Study Day 1
  13. Resting oxygen saturation of < 90%
  14. Pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg by echo or catheter criteria on Study Day 1
  15. Unstable angina, Canadian Cardiovascular Society (CCS) Class IV severity, with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin; CCS grading criteria are provided in Appendix E of the protocol (see Appendix 16.1.1)
  16. Second degree heart block or greater
  17. Use of intravenous or intracoronary contrast agent within the 24 hours prior to Study Day 1
  18. Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives, ie, drug dependence, psychiatric disorder, dementia, or other reasons for expected poor compliance with the Investigator's instructions; medical conditions, associated illness, or extenuating circumstances that made it unlikely that a patient can complete the clinical trial or follow-up evaluations

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Technical adequacy and diagnostic quality of PB127 images
Tidsramme: 24 hours
24 hours

Sekundære resultatmål

Resultatmål
Tidsramme
Compliance with image acquisition and Pb127 administration procedures
Tidsramme: 24 hours
24 hours

Samarbejdspartnere og efterforskere

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

Sponsor

Point Biomedical

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. februar 2002

Primær færdiggørelse (Faktiske)

1. september 2003

Studieafslutning (Faktiske)

1. september 2003

Datoer for studieregistrering

Først indsendt

4. januar 2008

Først indsendt, der opfyldte QC-kriterier

4. januar 2008

Først opslået (Skøn)

16. januar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. juli 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2008

Sidst verificeret

1. januar 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 127-005

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 .

Kliniske forsøg med Koronararteriesygdom

Kliniske forsøg med PB127 for injectable suspension

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in China

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner