- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00514501
Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome (Zeus-ACS)
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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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British Columbia
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North Vancouver, British Columbia, Canada
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Ontario
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Scarborough, Ontario, Canada
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Alabama
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Birmingham, Alabama, Stati Uniti
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Huntsville, Alabama, Stati Uniti
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Arizona
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Mesa, Arizona, Stati Uniti
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California
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Los Angeles, California, Stati Uniti
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Mission Viejo, California, Stati Uniti
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Newport Beach, California, Stati Uniti
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Roseville, California, Stati Uniti, 95661
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Connecticut
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Hartford, Connecticut, Stati Uniti
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New Haven, Connecticut, Stati Uniti
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Delaware
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Newark, Delaware, Stati Uniti
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Florida
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Jacksonville, Florida, Stati Uniti
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Illinois
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Aurora, Illinois, Stati Uniti
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Maywood, Illinois, Stati Uniti
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40207
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Maine
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Auburn, Maine, Stati Uniti
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Maryland
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Bethesda, Maryland, Stati Uniti
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Michigan
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Detroit, Michigan, Stati Uniti
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Royal Oak, Michigan, Stati Uniti
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Troy, Michigan, Stati Uniti, 48085
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Minnesota
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Minneapolis, Minnesota, Stati Uniti
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Missouri
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Kansas City, Missouri, Stati Uniti, 64111
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti
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Manchester, New Hampshire, Stati Uniti
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New York
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Albany, New York, Stati Uniti
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Brooklyn, New York, Stati Uniti
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Kingston, New York, Stati Uniti
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New York, New York, Stati Uniti
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Rochester, New York, Stati Uniti
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Syracuse, New York, Stati Uniti, 13210
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Ohio
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Cincinnati, Ohio, Stati Uniti
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Cleveland, Ohio, Stati Uniti
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Columbus, Ohio, Stati Uniti
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Rhode Island
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Providence, Rhode Island, Stati Uniti
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Texas
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Houston, Texas, Stati Uniti
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Virginia
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Richmond, Virginia, Stati Uniti
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Wisconsin
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Madison, Wisconsin, Stati Uniti
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Iodofiltic Acid I 123
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Norman LaFrance, MD, Molecular Insight Pharmaceuticals, Inc.
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MIP-BP23
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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