Estradiol For Neurocognitive Dysfunction After CABG

雌二醇治疗冠状动脉搭桥术后神经认知功能障碍

• 批准号: 6537761
• 负责人: CHARLES W HOGUE
• 金额: $ 54.1万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-06-01 至 2006-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6537761
• 关键词: behavioral /social science research tag; chemoprevention; cognition disorders; coronary bypass; estradiol; hormone therapy; human subject; human therapy evaluation; nerve injury; nervous system disorder chemotherapy; neurologic manifestations; neuropsychological tests; patient oriented research; postoperative state; quality of life; women's health

Women undergoing coronary artery bypass graft (CABG) surgery have a higher operative mortality rate, longer hospitalizations, and higher hospital cost compared with men. A large proportion of this excess morbidity and mortality of surgery for women is due to perioperative neurologic injury. Estrogens have been consistently shown to reduce the extent of neurologic injury in a variety of in vitro and animal experimental stroke models. These data together strongly suggest that the higher risk for perioperative neurologic complications for elderly women may relate to their estrogen deficient state. In this randomized, placebo controlled study, we will test the hypothesis that perioperative estrogen replacement in postmenopausal women reduces the risk for neurologic injury after CABG surgery. Three hundred thirty four women undergoing CABG surgery will be prospectively randomized to receive either 17beta-estradiol or placebo in a double-blind fashion beginning the day before surgery and continued for 5 days after surgery. Patients will be assessed for neurocognitive dysfunction, the most common manifestation of neurologic injury from cardiac surgery. Neurocognitive testing will be performed 1-2 days before surgery, 4 to 6 weeks postoperatively, and 6- months after surgery. The primary endpoint will be neurocognitive function 4 to 6 weeks after surgery for women who received 17beta- estradiol compared with placebo perioperatively. We will also evaluate for the importance of postoperative cognitive decline on measures of cognitive function and quality of life 6 months after surgery and whether perioperative 17beta-estradiol treatment improves these latter outcomes. The results of this study will evaluate the efficacy and safety of an easily implemented therapy for improving neurologic outcome and quality of life after CABG surgery for postmenopausal women.

与男性相比，接受冠状动脉旁路移植术（CABG）的女性手术死亡率更高，住院时间更长，住院费用更高。女性手术的超额发病率和死亡率的很大一部分是由于围手术期神经损伤。在各种体外和动物实验中风模型中，雌激素一直被证明可以减少神经损伤的程度。这些数据表明，老年妇女围手术期神经系统并发症的高风险可能与雌激素缺乏有关。在这项随机安慰剂对照研究中，我们将检验绝经后妇女围手术期雌激素替代可降低CABG术后神经损伤风险的假设。334名接受冠状动脉搭桥手术的妇女将以双盲的方式随机接受17 -雌二醇或安慰剂，从手术前一天开始，持续到手术后5天。患者将评估神经认知功能障碍，这是心脏手术神经损伤最常见的表现。术前1-2天、术后4 - 6周、术后6个月分别进行神经认知测试。主要终点将是术后4 - 6周接受17 β -雌二醇治疗的女性与围手术期接受安慰剂治疗的女性的神经认知功能。我们还将评估术后认知能力下降对术后6个月认知功能和生活质量测量的重要性，以及围手术期17 -雌二醇治疗是否改善了这些后一项结果。本研究的结果将评估一种易于实施的治疗方法的有效性和安全性，以改善绝经后妇女CABG手术后的神经预后和生活质量。