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Safety and Efficacy Study of PB127 Ultrasound Contrast Agent in Patients With Suspected Coronary Artery Disease 007

1. juli 2008 opdateret af: Point Biomedical
This trial is to compare PB127 echocardiography to other heart imaging studies.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

428

Fase

  • 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
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic Scottsdale
      • Scottsdale, Arizona, Forenede Stater, 85258
        • Heartcare, P.C.
    • California
      • San Francisco, California, Forenede Stater, 94143
        • University of California San Francisco
      • Stanford, California, Forenede Stater, 94305
        • Stanford University 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 & Crouse Cardiology
    • Maine
      • Auburn, Maine, Forenede Stater, 04210
        • Androscoggin Cardiovascular Associates
      • South Portland, Maine, Forenede Stater, 04106
        • Maine Cardiology Associates
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Cardiovascular Consultants
      • St. Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Hospital
      • New York, New York, Forenede Stater, 10025
        • St. Luke's Roosevelt Hospital Echocardiography Lab
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43214
        • MidWest Cardiologist Research
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401
        • Endovascular Research, LLC
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Austin Heart
      • Dallas, Texas, Forenede Stater, 75231
        • Presbyterian Hospital of Dallas
      • Houston, Texas, Forenede Stater, 77030
        • Methodist DeBakery Heart Center Cardiovascular Imaging Institute
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia Health System
    • Washington
      • 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:

Stratum 1:

  1. Able to provide written informed consent
  2. Low (less than 10%) pre-test probability of CAD (Appendix D)
  3. Scheduled for clinically indicated stress echocardiography or stress SPECT within the 14 days prior to or following Study Day 1 (prior to coronary angiography) or coronary angiography within the 7 days following Study Day 1
  4. Technically adequate unreconstructed stress SPECT data or scheduled for clinically indicated stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
  5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
  6. No evidence of a right-to-left shunt during non-contrast echocardiography

Stratum 2:

  1. Able to provide written informed consent
  2. Intermediate (10% to 90%) pre-test probability of CAD (Appendix D)
  3. Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
  4. Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
  5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
  6. No evidence of a right-to-left shunt during non-contrast echocardiography

Stratum 3:

  1. Able to provide written informed consent
  2. High (greater than 90%) pre-test probability of CAD (Appendix D)
  3. Scheduled for clinically indicated coronary angiography within the 7 days following Study Day 1
  4. Technically adequate unreconstructed stress SPECT data or scheduled for stress SPECT within 14 days of Study Day 1 and prior to coronary angiography
  5. Adequate visualization of all myocardial segments in at least one view during non-contrast echocardiography (See Section 5.3.1)
  6. No evidence of a right-to-left shunt during non-contrast echocardiography

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 PB127 MCE
  4. Previous exposure to PB127 Ultrasound Contrast Agent
  5. Heart transplant
  6. Known right-to-left shunt including atrial septal defect
  7. Current or history of uncontrolled ventricular tachycardia
  8. Current atrial fibrillation, atrial tachycardia, or atrial flutter
  9. Pacemaker or defibrillator

  10. Unstable cardiac status

    1. Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin (See Appendix F)
    2. Second-degree or greater heart block
    3. Frequent (>60/hour) or symptomatic ventricular ectopics at baseline
    4. Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within one hour of PB127 MCE)
    5. Hypotension (SPB <90 mmHg)
    6. Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
    7. Pulmonary edema within the 7 days prior to Study Day 1
    8. Resting oxygen saturation of less than 90%
    9. Q-wave myocardial infarction within the 7 days prior to Study Day 1
    10. PTCA or CABG within the 7 days prior to Study Day 1
  11. Chronic Obstructive Pulmonary Disease (COPD) or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
  12. Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg
  13. Use of intravenous or intracoronary contrast agent other than thallium or technetium within the 24 hours prior to Study Day 1

  14. Liver disease (i.e., current or previous hepatic viral infection, chronic hepatitis) 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
  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, 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 Investigator's instructions

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
At demonstrere non-inferioriteten af ​​den diagnostiske ydeevne af PB127 MCE versus stress SPECT ved påvisning og/eller udelukkelse af signifikant obstruktiv CAD som defineret af QCA eller kvalificerende kliniske resultat.
Tidsramme: 90 dage
90 dage

Sekundære resultatmål

Resultatmål
Tidsramme
At vurdere overensstemmelsen mellem PB127 MCE og stress SPECT ved at skelne mellem reversible vs. fikserede defekter hos patienter med signifikant obstruktiv CAD
Tidsramme: 28 dage
28 dage
At sammenligne den diagnostiske ydeevne af PB127 MCE med stress SPECT ved identifikation af placeringen af ​​stenose som identificeret ved koronar angiografi.
Tidsramme: 28 dage
28 dage

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. juli 2002

Primær færdiggørelse (Faktiske)

1. oktober 2003

Studieafslutning (Faktiske)

1. oktober 2003

Datoer for studieregistrering

Først indsendt

7. januar 2008

Først indsendt, der opfyldte QC-kriterier

7. 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. juli 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 127-007

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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