CARDIAC VALVE SURGERY AND NIMODIPINE NEUROPROTECTION

心脏瓣膜手术和尼莫地平神经保护

• 批准号: 3846989
• 负责人: STEPHEN A MILLS
• 金额: --
• 依托单位: WAKE FOREST UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3846989
• 关键词: adult human (21+); aortic valve; attention; brain metabolism; calcium channel blockers; cerebral ischemia /hypoxia; cerebrovascular disorders; clinical trials; disease /disorder proneness /risk; eye movement disorders; heart surgery; histopathology; human subject; human therapy evaluation; infarct; memory disorders; mitral valve; nervous system disorder; nervous system disorder diagnosis; neurologic manifestations; neuropharmacologic agent; neuropsychological tests; neuropsychology; oxygen consumption; postmortem; postoperative complications; psychomotor disorders; stroke; vision disorders; vision tests

50,000 cardiac valve replacements (CVR) are performed each year in the United States. Despite decreased surgical mortality, neurologic, neuro- ophthalmologic, and neuropsychologic morbidity remains at least twice that associated with aortocoronary bypass. Interventions that decrease the incidence of postoperative cognitive dysfunction are urgently needed. This randomized, placebo-controlled trial will consist of the administration of nimodipine pre- and postoperatively to patients undergoing CVR to determine: 1. Whether nimodipine, compared to placebo, alters the combined prevalence of new post-cardiac valve replacement neurologic, neuro-ophthalmologic, and neuropsychologic deficits 5-7 days postoperatively. 2. Whether nimodipine, compared to placebo, alters the length of post- cardiac valve replacement hospital stay. 3. Whether nimodipine, compared to placebo, alters the combined prevalence of residual post-cardiac valve replacement neurologic, neuro- ophthalmologic, and neuropsychologic deficits 6 months postoperatively. 4.Whether nimodipine, compared to placebo, alters intraoperative global CBF and cerebral metabolic indices (e.g. jugular venous oxygen saturation). 5. The relationship between cerebral blood flow and cerebral metabolism and neurologic, neuro-ophthalmologic, and neuropsychologic outcome. 6. Whether demographic factors (such as advanced age) and CPB factors (such as hypotension and prolonged CPB duration) are associated with a higher prevalence of new post-cardiac valve replacement neurologic, neuro- ophthalmologic, and neuropsychologic deficits. The Program Project of which this project is a component has combined the multidisciplinary resources necessary to establish the effects of nimodipine on neurologic outcome and to correlate the pharmacologic effects of nimodipine on cerebral blood flow and metabolism with subsequent outcome. If the information obtained from this study results in a decrease in the prevalence of neurologic deficits following these common operations, the social and financial benefit to society would be great.

每年进行 50,000 例心脏瓣膜置换术 (CVR) 美国。 尽管手术死亡率降低，但神经系统、神经系统 眼科和神经心理学发病率至少是以前的两倍 与主动脉冠状动脉搭桥术相关。 减少的干预措施 术后认知功能障碍的发生率亟待研究。 这 随机、安慰剂对照试验将包括 接受 CVR 的患者术前和术后使用尼莫地平 决定： 1. 与安慰剂相比，尼莫地平是否改变了综合患病率 新的心脏瓣膜置换术后神经病学、神经眼科和 术后5-7天出现神经心理缺陷。 2. 与安慰剂相比，尼莫地平是否会改变术后的时间长度？ 心脏瓣膜置换住院。 3. 与安慰剂相比，尼莫地平是否改变了综合患病率 心脏瓣膜置换术后残留的神经病学、神经- 术后 6 个月出现眼科和神经心理缺陷。 4.与安慰剂相比，尼莫地平是否改变术中整体CBF 和脑代谢指数（例如颈静脉血氧饱和度）。 5、脑血流量与脑代谢的关系 神经病学、神经眼科和神经心理学结果。 6.是否有人口因素（如高龄）和CPB因素（如 因为低血压和延长 CPB 持续时间）与较高的 新心脏瓣膜置换术后神经系统、神经系统疾病的流行 眼科和神经心理学缺陷。 该项目所属的计划项目结合了 确定效果所需的多学科资源 尼莫地平对神经系统结果的影响及其药理作用的相关性 尼莫地平对脑血流和代谢的影响 结果。 如果从本研究中获得的信息导致减少 这些常见手术后神经功能缺损的患病率， 给社会带来的社会和经济效益将是巨大的。