对于没有心房动的膜疾病患者的左心房尾闭塞 (OPINION研究):多中心,随机对照试验的研究协议
Fan Ju1, Xin Yuan1, Hansong Sun2
1Department of Cardiac Surgery, Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital, Xicheng District, Beijing, China.
BMJ open
|February 7, 2024
概括
在门手术期间进行的外科左心房附属体封闭 (SLAAO) 可以预防没有心房动 (AF) 的患者的长期中风. 这项试验调查了SLAAOO.
科学领域:
- 心血管外科心血管外科
- 神经学 神经学
- 临床试验 临床试验
背景情况:
- 心房动 (AF) 是大动脉和 mitra 门手术中术前中风的主要原因.
- 关于外科手术左心房尾闭塞 (SLAAO) 的以前的研究是回顾性的,可能有混因素.
- 心脏手术期间的机会性SLAAO正在特定患者群体的中风预防中进行研究.
研究的目的:
- 测试机会主义SLAAO可以预防心脏手术后的长期中风的假设.
- 评估SLAAO在没有AF病史和CHA2DS2-VASc分数为2或更高的接受米特拉或大动脉手术的患者的疗效.
- 评估SLAAO对中风和心血管死亡率的影响.
主要方法:
- 一个单盲,多中心,随机对照试验,涉及2118名患者.
- 没有AF进行大动脉或 mitra手术的患者将1:1随机分配到干预 (SLAAO) 或对照组.
- 主要结局是新的缺血性中风,短暂缺血性发作和1年内心血管死亡率的复合.
主要成果:
- 这一部分应在试验结果可用后填写.
- 该研究目前正在招募患者,尚未产生结果.
- 数据收集和分析将在患者随访完成后进行.
结论:
- 这项试验将提供关于SLAAO在预防高风险手术患者中风的有效性的关键数据.
- 这些发现将为临床实践提供有关在门手术期间预防性使用SLAAO的信息.
- 该研究旨在减少中风的发生率,并改善心脏手术患者的长期结果.
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