Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
2018年8月1日 更新者：GE Healthcare
A Phase 2, Double-Blind, Randomized, Safety Study of GE-145 320 mg I/mL Injection Versus Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Artery Catheterization Procedure
To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL.
The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.
研究概览
研究类型
介入性
注册 (实际的)
284
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
New Jersey
-
Princeton、New Jersey、美国、08540
- GE Healthcare
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI.
- The subject has at least one of the following comorbidities:
- 1) Chronic renal insufficiency, (eGFR <60 but 15 mL/min/1.73 m2 according to the MDRD equation) as measured within 2 weeks or at the screening visit;
- 2) DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
- 3) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.
Exclusion Criteria:
- The subject has known allergies to either iodine or any ICM.
- The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
- The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
- The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at the time of the study procedure.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：GE 145 320mg I/ml injection
|
GE-145-320 mg I/mL as a single iv.
administration.
Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv.
administration.
其他名称：
|
|
有源比较器：Iopamidol 370mg I/ml injection
|
GE-145-320 mg I/mL as a single iv.
administration.
Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv.
administration.
其他名称：
|
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 |
|---|---|---|
|
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.
大体时间：After the imaging date for either Ioforminol or Iopamidol.
|
Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.
|
After the imaging date for either Ioforminol or Iopamidol.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration
大体时间：Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.
|
To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol. To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol. Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects. |
Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.
|
|
Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections
大体时间：2, 6 and 24 hours post Ioforminol and Iopamidol adminstration
|
Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).
|
2, 6 and 24 hours post Ioforminol and Iopamidol adminstration
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Rubin Sheng, M.D.、GE Healthcare
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年11月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2012年12月1日
研究注册日期
首次提交
2010年12月1日
首先提交符合 QC 标准的
2010年12月1日
首次发布 (估计)
2010年12月3日
研究记录更新
最后更新发布 (实际的)
2018年8月29日
上次提交的符合 QC 标准的更新
2018年8月1日
最后验证
2018年8月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- GE 145-002
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.