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Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome (Zeus-ACS)

29. februar 2016 opdateret af: Molecular Insight Pharmaceuticals, Inc.

Open-label, Phase 2 Study of the Safety and Efficacy of B-methyl-P-(123I)- Iodophenyl-pentadecanoic Acid (Iodofiltic Acid I 123) For Identification of Ischemic Myocardium Using Single Photon Emission Computed Tomography (Spect) in Adults With Symptoms Consistent With Acute Coronary Syndrome (ACS).

This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123 for the detection of myocardial ischemia. Readers independent of the clinical study centers will review results of imaging studies in a blinded fashion at an imaging core lab. The resulting independent reading of the images will be compared against the truth standard for ACS.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

510

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
    • British Columbia
      • North Vancouver, British Columbia, Canada
    • Ontario
      • Scarborough, Ontario, Canada
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
      • Huntsville, Alabama, Forenede Stater
    • Arizona
      • Mesa, Arizona, Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater
      • Mission Viejo, California, Forenede Stater
      • Newport Beach, California, Forenede Stater
      • Roseville, California, Forenede Stater, 95661
    • Connecticut
      • Hartford, Connecticut, Forenede Stater
      • New Haven, Connecticut, Forenede Stater
    • Delaware
      • Newark, Delaware, Forenede Stater
    • Florida
      • Jacksonville, Florida, Forenede Stater
    • Illinois
      • Aurora, Illinois, Forenede Stater
      • Maywood, Illinois, Forenede Stater
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40207
    • Maine
      • Auburn, Maine, Forenede Stater
    • Maryland
      • Bethesda, Maryland, Forenede Stater
    • Michigan
      • Detroit, Michigan, Forenede Stater
      • Royal Oak, Michigan, Forenede Stater
      • Troy, Michigan, Forenede Stater, 48085
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater
      • Manchester, New Hampshire, Forenede Stater
    • New York
      • Albany, New York, Forenede Stater
      • Brooklyn, New York, Forenede Stater
      • Kingston, New York, Forenede Stater
      • New York, New York, Forenede Stater
      • Rochester, New York, Forenede Stater
      • Syracuse, New York, Forenede Stater, 13210
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
      • Cleveland, Ohio, Forenede Stater
      • Columbus, Ohio, Forenede Stater
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater
    • Virginia
      • Richmond, Virginia, Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater

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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Provide written informed consent and are willing to comply with protocol requirements
  • Are 40 years of age or older.
  • Are being evaluated for possible ACS.
  • If female, then not of childbearing potential as documented by history or has a negative serum or urine pregnancy test within 4 hours prior to receiving the test drug and agrees to use an acceptable form of birth control.

Exclusion Criteria:

  • <40 years of age.
  • Females who are pregnant or lactating.
  • History of left ventricular ejection fraction (LVEF)=40%.
  • History of MI.
  • Acute ST segment elevation on ECG.
  • Left bundle branch block on ECG.
  • Known history of significant allergy to x-ray contrast media or iodine/iodides.
  • Currently or formerly on medication that targets fatty acid uptake or metabolism, eg ranolazine, (Ranexa).
  • Administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days prior to study enrollment.
  • Underwent cardiac stress testing of any kind within 2 days prior to study enrollment.
  • Serum creatinine level >2.0 mg per dL.
  • Received investigational compound and/or medical device within 30 days of admission into this study.
  • Q-wave abnormalities consistent with previous MI

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Iodofiltic Acid I 123
Medicin: Iodofiltic acid I 123

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
Tidsramme: Day 30

Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).

Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.

Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Day 30
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)
Tidsramme: Day 30

Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).

Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.

Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Day 30
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)
Tidsramme: Day 30

Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).

Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.

Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Day 30

Samarbejdspartnere og efterforskere

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

Sponsor

Molecular Insight Pharmaceuticals, Inc.

Efterforskere

  • Studieleder: Norman LaFrance, MD, Molecular Insight Pharmaceuticals, Inc.

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

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. maj 2007

Primær færdiggørelse (Faktiske)

1. juni 2008

Studieafslutning (Faktiske)

1. december 2008

Datoer for studieregistrering

Først indsendt

8. august 2007

Først indsendt, der opfyldte QC-kriterier

9. august 2007

Først opslået (Skøn)

10. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MIP-BP23

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 Akut koronarsyndrom

Kliniske forsøg med Iodofiltic acid I 123

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Estonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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