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- Klinische proef 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).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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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, Verenigde Staten
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Huntsville, Alabama, Verenigde Staten
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Arizona
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Mesa, Arizona, Verenigde Staten
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California
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Los Angeles, California, Verenigde Staten
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Mission Viejo, California, Verenigde Staten
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Newport Beach, California, Verenigde Staten
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Roseville, California, Verenigde Staten, 95661
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Connecticut
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Hartford, Connecticut, Verenigde Staten
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New Haven, Connecticut, Verenigde Staten
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Delaware
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Newark, Delaware, Verenigde Staten
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Florida
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Jacksonville, Florida, Verenigde Staten
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Illinois
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Aurora, Illinois, Verenigde Staten
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Maywood, Illinois, Verenigde Staten
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40207
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Maine
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Auburn, Maine, Verenigde Staten
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Maryland
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Bethesda, Maryland, Verenigde Staten
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Michigan
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Detroit, Michigan, Verenigde Staten
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Royal Oak, Michigan, Verenigde Staten
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Troy, Michigan, Verenigde Staten, 48085
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64111
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten
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Manchester, New Hampshire, Verenigde Staten
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New York
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Albany, New York, Verenigde Staten
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Brooklyn, New York, Verenigde Staten
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Kingston, New York, Verenigde Staten
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New York, New York, Verenigde Staten
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Rochester, New York, Verenigde Staten
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Syracuse, New York, Verenigde Staten, 13210
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Ohio
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Cincinnati, Ohio, Verenigde Staten
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Cleveland, Ohio, Verenigde Staten
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Columbus, Ohio, Verenigde Staten
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Rhode Island
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Providence, Rhode Island, Verenigde Staten
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Texas
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Houston, Texas, Verenigde Staten
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Virginia
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Richmond, Virginia, Verenigde Staten
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Wisconsin
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Madison, Wisconsin, Verenigde Staten
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Iodofiltic Acid I 123
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
Tijdsspanne: Day 30
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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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Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)
Tijdsspanne: Day 30
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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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Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)
Tijdsspanne: Day 30
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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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Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Norman LaFrance, MD, Molecular Insight Pharmaceuticals, Inc.
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MIP-BP23
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