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Safety and Efficacy Study of PB127 Ultrasound Contrast Agent for Diagnosis of Coronary Artery Disease (POINT II)

1. juli 2008 oppdatert av: Point Biomedical

A Phase 3 Clinical Trial to Assess Perfusion and Obstruction Identified by Non-Invasive Technology Using PB127 Ultrasound Contrast Agent in Patients With Suspected Obstructive Coronary Artery Disease II

The purpose of this study is to determine if the use of PB127 with cardiac ultrasound assists in the diagnosis or exclusion of coronary artery disease.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

1000

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Tucson, Arizona, Forente stater, 85724
        • University of Arizona Saver Heart Clinic
    • California
      • Burlingame, California, Forente stater, 94010
        • Cardiovascular Associates of the Peninsula
      • Long Beach, California, Forente stater, 90822
        • Long Beach VA Medical Center Cardiology Division
      • Los Angeles, California, Forente stater, 90048
        • Cedars Sinai Medical Center Division of Cardiology
      • Roseville, California, Forente stater, 95661
        • Sutter Roseville Medical Center
      • San Diego, California, Forente stater, 92103
        • University of California San Diego Division of Cardiology
      • San Francisco, California, Forente stater, 94121
        • San Francisco VA Medical Center NCIRE
    • Connecticut
      • Bridgeport, Connecticut, Forente stater, 06606
        • Connecticut Clinical Research
    • Delaware
      • Newark, Delaware, Forente stater, 19713
        • Alfieri Cardiology
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20010
        • Washington Hospital Center Cardiovascular Research Institute
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern University Feinberg School of Medicine
    • Kansas
      • Overland Park, Kansas, Forente stater, 66209
        • Midwest Cardiology Associates
      • Shawnee Mission, Kansas, Forente stater, 66204
        • The Center for Cardiovascular Studies Kramer & Crouse Cardiology
    • Kentucky
      • Paducah, Kentucky, Forente stater, 42001
        • Western Baptist Hospital The Heart Group
    • Maine
      • Auburn, Maine, Forente stater, 04210
        • Androscoggin Cardiovascular Associates
      • South Portland, Maine, Forente stater, 04106
        • Maine Cardiology Associates
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham & Women's Hosptial
    • Michigan
      • Detroit, Michigan, Forente stater
        • Henry Ford Hospital
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Department of Cardiology
    • Missouri
      • Kansas City, Missouri, Forente stater, 64111
        • Cardiovascular Consultants
      • St. Louis, Missouri, Forente stater, 63110
        • St. Louis University Medical Center
    • New York
      • Manhasset, New York, Forente stater, 11030
        • North Shore University Hospital
      • New York, New York, Forente stater, 10025
        • St. Luke's Roosevelt Hospital Echocardiography Lab
      • Stonybrook, New York, Forente stater, 11794
        • Stonybrook University Medical Center
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center
      • High Point, North Carolina, Forente stater, 27262
        • Carolina Cardiology Associates
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • The Cleveland Clinic Foundation Department of Cardiology
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University College of Medicine and Public Health
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater
        • University of Oklahoma Health Sciences Center VA Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh Cardiovascular Institute
    • Texas
      • Austin, Texas, Forente stater, 78705
        • Austin Heart
      • Austin, Texas, Forente stater, 78701
        • Seton Healthcare Network Brackenridge Hospital
      • Fort Worth, Texas, Forente stater, 76104
        • Consultants in Cardiology
      • Galveston, Texas, Forente stater, 77555
        • University of Texas Division of Cardiology
      • Houston, Texas, Forente stater, 77030
        • Methodist DeBakery Heart Center Cardiovascular Imaging Institute
      • Houston, Texas, Forente stater, 77030
        • University of Texas Health Science Center Memorial Hermann Heart & Vascular Institute
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Harborview Medical Center Department of Cardiology
      • Spokane, Washington, Forente stater, 99204
        • Heart Clinics Northwest
      • Spokane, Washington, Forente stater, 99204
        • Northwest Cardiovascular Research Institute Spokane Cardiology
      • Spokane, Washington, Forente stater, 99204
        • Inland Cardiology

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

  1. 18 years old or older and able to provide written informed consent;
  2. All subjects must be scheduled for or have undergone SPECT within 28 days prior to or following Study Day 1
  3. Subjects with very low/low pre-test probability of coronary artery disease must consent to participate in the extension trial 127-014-A
  4. Subjects with very low/low pre-test probability of coronary artery disease must not have a current diagnosis of obstructive CAD on angiogram or prior MI
  5. Subjects with very low/low pre-test probability of coronary artery disease with a current diagnosis of obstructive CAD on angiogram or prior MI may be enrolled into Stratum 2
  6. Subjects with intermediate or high pre-test probability of coronary artery disease must be scheduled for coronary angiography within the 28 days following Study Day 1
  7. Sinus rhythm at the time of the study procedure
  8. Adequate visualization of myocardial segments
  9. Appropriate candidate for stress testing according to ACC/AHA Guidelines for Exercise Testing

Exclusion Criteria:

  1. Women who are pregnant or lactating

  2. Known hypersensitivity or known contraindication to:

    1. Dipyridamole
    2. Ultrasound contrast agents (including PB127 and excipients)
    3. Blood, blood products, albumin, egg, or protein
  3. Use of caffeine or xanthine containing products within the 24 hours prior to Study Day 1
  4. Previous exposure to PB127 Ultrasound Contrast Agent
  5. Major surgery within 7 days prior to Study Day 1 (requiring general anesthesia and/or overnight stay)
  6. Heart transplant or history of CABG
  7. Known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior TIAs or strokes)
  8. Recent history of sustained ventricular tachycardia
  9. Pacemaker or defibrillator

  10. Unstable cardiac status

    1. Unstable angina grade CCS Class IV severity (any physical activity causes limiting symptoms; symptoms may be present at rest in a patient with prior exertional angina) with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin
    2. Decompensated heart failure
    3. Second-degree or greater heart block, sick sinus syndrome
    4. Frequent (>60/hour) or symptomatic ventricular ectopics at baseline
    5. Hypertension (SBP >200 and/or DBP >110 mmHg on two consecutive readings within one hour of PB127 MPE)
    6. Hypotension (SBP <90 mmHg)
    7. Severe aortic stenosis (>40 mmHg mean gradient or <0.6 cm2/m2 valve area index)
    8. Pulmonary edema within the 7 days prior to Study Day 1
    9. Resting oxygen saturation of less than 90% on room air
  11. Myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 days prior to Study Day 1
  12. Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease, which in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
  13. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg

  14. Liver disease characterized by one or more of the following

    1. Current jaundice
    2. Elevated bilirubin > upper limit of normal
    3. Currently elevated hepatic enzymes > 2X upper limit of normal
    4. Current or previous hepatic viral infection (not including hepatitis A)
    5. Chronic hepatitis
  15. Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
To evaluate the diagnostic performance of PB127 MPE for the detection and/or exclusion of significant obstructive coronary artery disease as defined by qualitative coronary angiography or qualifying clinical outcome
Tidsramme: 72 hours, 6 months
72 hours, 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
To compare the diagnostic performance of PB127 MPE to SPECT for the detection and/or exclusion of significant obstructive coronary artery disease.
Tidsramme: 72 hours, 6 months
72 hours, 6 months
To assess the concordance of PB127 MPE with SPECT in the differentiation of defect type (fixed versus reversible) in patients with significant obstructive CAD.
Tidsramme: 72 hours, 6 months
72 hours, 6 months
To evaluate the diagnostic performance characteristics of PB127 MPE for identifying the location of significant obstructive CAD as defined by quantitative coronary angiography
Tidsramme: 72 hours
72 hours
To assess the change in diagnostic certainty when PB127 MPE and relevant clinical information are combined over relevant clinical information alone.
Tidsramme: 72 hours, 6 months
72 hours, 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Point Biomedical

Etterforskere

  • Studieleder: Alexander Ehlgen, MD, PhD, POINT Biomedical Corp

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2007

Primær fullføring (Faktiske)

1. juli 2008

Studiet fullført (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først innsendt

20. desember 2007

Først innsendt som oppfylte QC-kriteriene

20. desember 2007

Først lagt ut (Anslag)

2. januar 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. juli 2008

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2008

Sist bekreftet

1. juli 2008

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 127-014

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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