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).
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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British Columbia
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North Vancouver、British Columbia、加拿大
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Ontario
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Scarborough、Ontario、加拿大
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Alabama
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Birmingham、Alabama、美国
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Huntsville、Alabama、美国
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Arizona
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Mesa、Arizona、美国
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California
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Los Angeles、California、美国
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Mission Viejo、California、美国
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Newport Beach、California、美国
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Roseville、California、美国、95661
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Connecticut
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Hartford、Connecticut、美国
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New Haven、Connecticut、美国
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Delaware
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Newark、Delaware、美国
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Florida
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Jacksonville、Florida、美国
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Illinois
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Aurora、Illinois、美国
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Maywood、Illinois、美国
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Kentucky
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Louisville、Kentucky、美国、40207
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Maine
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Auburn、Maine、美国
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Maryland
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Bethesda、Maryland、美国
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Michigan
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Detroit、Michigan、美国
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Royal Oak、Michigan、美国
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Troy、Michigan、美国、48085
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Minnesota
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Minneapolis、Minnesota、美国
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Missouri
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Kansas City、Missouri、美国、64111
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New Hampshire
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Lebanon、New Hampshire、美国
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Manchester、New Hampshire、美国
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New York
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Albany、New York、美国
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Brooklyn、New York、美国
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Kingston、New York、美国
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New York、New York、美国
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Rochester、New York、美国
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Syracuse、New York、美国、13210
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Ohio
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Cincinnati、Ohio、美国
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Cleveland、Ohio、美国
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Columbus、Ohio、美国
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Rhode Island
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Providence、Rhode Island、美国
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Texas
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Houston、Texas、美国
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Virginia
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Richmond、Virginia、美国
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Wisconsin
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Madison、Wisconsin、美国
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Iodofiltic Acid I 123
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
大体时间: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)
大体时间: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)
大体时间: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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合作者和调查者
调查人员
- 研究主任:Norman LaFrance, MD、Molecular Insight Pharmaceuticals, Inc.
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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Iodofiltic acid I 123的临床试验
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Alseres Pharmaceuticals, Inc未知
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Assistance Publique - Hôpitaux de ParisAssociation Française contre les Myopathies (AFM), Paris; ARS (Association pour la Recherche... 和其他合作者完全的
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Asan Medical Center终止
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Institute for Neurodegenerative DisordersMolecular NeuroImaging完全的