他汀类药物治疗可限制心脏手术后的认知功能障碍
2015年10月11日 更新者：Duke University
我们的前瞻性、随机、双盲介入临床试验的主要目的是确定高剂量阿托伐他汀治疗对减少心脏瓣膜手术患者术后认知功能障碍 (POCD) 的有效性。
我们假设使用高剂量阿托伐他汀治疗会显着降低 POCD 的发生率和/或严重程度。
研究概览
研究类型
介入性
阶段
- 不适用
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
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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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
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 50 名知情同意并同意接受 CPB 心脏瓣膜手术的患者，年龄超过 50 岁，在一名或多名研究人员或顾问的照顾下，将在一年内前瞻性招募（加上一年的随访).
排除标准：
具有以下疾病病史的患者将被排除在外：
- 症状性脑血管疾病伴大量残留缺陷、酗酒、精神疾病、肾功能衰竭（肌酐>2.0），
- 肝功能障碍（ALT 或 AST > 1.5 x ULN）、他汀类药物治疗过敏或肌病史、孕妇或哺乳期妇女或研究者认为可能限制患者参与的其他合并症。 排除标准旨在限制混淆并增强与手术和/或治疗相关的缺陷的区分。
- 无法阅读因此无法完成神经认知测试的患者也将被排除在外。
- 同时进行颈动脉内膜切除术或其他血管手术的患者也将被排除在外，以提供更均匀的样本进行比较。
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：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：安慰剂
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术前 48 至 72 小时开始并持续至术后 6 周的高剂量阿托伐他汀治疗（80 毫克/天）
其他名称：
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实验性的：阿托伐他汀
术前 48 至 72 小时开始并持续至术后 6 周的高剂量阿托伐他汀治疗（80 毫克/天）
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术前 48 至 72 小时开始并持续至术后 6 周的高剂量阿托伐他汀治疗（80 毫克/天）
其他名称：
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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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神经认知功能障碍
大体时间：手术后 6 周和 1 年
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受试者将在基线、手术后 6 周和手术后 1 年接受一系列神经学测试，以评估神经认知状态。
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手术后 6 周和 1 年
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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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10月1日
初级完成 (预期的)
2011年10月1日
研究完成 (预期的)
2012年10月1日
研究注册日期
首次提交
2010年8月19日
首先提交符合 QC 标准的
2010年8月20日
首次发布 (估计)
2010年8月23日
研究记录更新
最后更新发布 (估计)
2015年10月14日
上次提交的符合 QC 标准的更新
2015年10月11日
最后验证
2011年2月1日
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.