使用右美托咪定保护心肌损伤的评价 (UDOPIE)
术前鼻内右美托咪定对经皮冠状动脉介入治疗患者围术期心肌损伤和心肌梗死的影响：一项前瞻性随机对照试验
本临床试验旨在探究术前经鼻滴入右美托咪定是否能减少择期经皮冠状动脉介入治疗（PCI）患者围术期心肌损伤和心肌梗死的发生。同时还将评估经鼻右美托咪定的安全性。主要研究问题包括：
术前经鼻右美托咪定能否降低PCI后围术期心肌损伤和心肌梗死的发生率？经鼻右美托咪定在接受PCI的患者中是否存在安全隐患？研究人员将比较经鼻右美托咪定与安慰剂（外观相似但不含药物）的作用，以确认经鼻右美托咪定在PCI期间对心脏的保护效果。
参与者将：
在PCI术前15分钟接受经鼻右美托咪定（100 μg）或安慰剂（生理盐水）；术前及术后接受血液检测以测量心脏肌钙蛋白水平；术后随访30天，记录任何心脏相关事件或副作用。
研究概览
详细说明
冠心病仍然是全球主要健康负担。经皮冠状动脉介入治疗已成为冠心病治疗的基石，有效降低了死亡率。尽管其成功，围手术期心肌损伤是常见并发症，根据定义和心脏生物标志物的敏感性，发生率在5-30%之间。PMI范围从轻度、无症状的高敏心肌肌钙蛋白升高到明显的心肌梗死。即使肌钙蛋白轻微升高也与30天和长期主要不良心血管事件增加以及支架血栓和再狭窄率升高独立相关。PMI的病理生理学是多因素的，包括远端栓塞、分支闭塞、冠状动脉夹层，以及在手术过程中心肌氧供需失衡等。<\/p>
镇静通常在PCI期间用于缓解焦虑、疼痛和压力；然而，镇静剂的选择及其对心肌结局的影响仍存在争议。右美托咪定是一种高度选择性α2-肾上腺素受体激动剂，提供镇静且呼吸抑制最小，在临床前和临床研究中已显示出潜在的心脏保护作用，可能是通过降低交感神经张力、减少心肌耗氧量以及减轻炎症和氧化应激反应。鼻内给药提供了非侵入性、便捷且吸收迅速的途径，使其成为术前用药的有吸引力选择。然而，缺乏来自大规模、多中心随机对照试验的有力证据。<\/p>
本试验旨在评估术前鼻内右美托咪定的使用，与安慰剂相比能否降低择期PCI患者围手术期心肌损伤和心肌梗死的发生率。<\/p>
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Min Yan, Doctor
- 电话号码：15888210247
- 邮箱：zryanmin@zju.edu.cn
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
入选标准：
- 18岁≤年龄≤85岁；
- 计划接受择期冠状动脉造影或经皮冠状动脉介入治疗（PCI）的患者；
- 美国麻醉医师协会（ASA）身体状况分级I-III级（从轻度全身性疾病到更严重的全身性疾病，限制正常体力活动但仍能完成轻度日常任务的患者）；
- 已获得知情同意。
排除标准：
- 对右美托咪定过敏或存在禁忌症，例如严重心动过缓（静息心率<50次/分钟）、病态窦房结综合征、二度或以上房室传导阻滞（未安装起搏器）；
- 严重心功能不全（左心室射血分数<35%或纽约心脏协会心功能分级III-IV级）、心源性休克或血流动力学不稳定的患者；
- 未控制的高血压（收缩压>180 mmHg或舒张压>110 mmHg）或低血压（收缩压<90 mmHg）；
- 睡眠呼吸暂停低通气综合征或体重指数>30 kg/m²；
- 术前1个月内使用过可能影响研究药物作用的α-2肾上腺能受体激动剂（如可乐定）或拮抗剂，或三环类抗抑郁药；
- 存在语言、视觉或听力障碍，可能影响认知评估；
- 肝功能或肾功能不全（丙氨酸氨基转移酶/天冬氨酸氨基转移酶/肌酐>正常上限3倍）；
- 鼻腔解剖结构异常，影响鼻内给药；
- 妊娠或哺乳期女性。
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：右美托咪定组
受试者在手术前15分钟于术前准备区接受鼻内右美托咪定（100微克，双侧鼻孔等量喷入，每侧鼻孔喷两次）。
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受试者在术前准备区接受右美托咪定鼻腔给药（100 μg，均匀喷入双侧鼻孔，每侧鼻孔两喷），于手术前15分钟进行。
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安慰剂比较：生理盐水组
受试者通过鼻腔给予等体积的生理盐水，其中不含活性成分。
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受试者被给予等量的不含活性成分的生理盐水进行鼻内给药。
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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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Incidence of perioperative myocardial injury
大体时间：From the end of surgery to 48 hours after surgery
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Definition of myocardial injury: In patients with a normal baseline cTn concentration (≤99th percentile upper reference limit [URL]), postoperative cTn elevation exceeding the 99th percentile URL; In patients with an elevated baseline cTn concentration (>99th percentile URL) that was stable or decreasing, a postoperative cTn increase of >20% from baseline, with an absolute value exceeding the 99th percentile URL.
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From the end of surgery to 48 hours after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of major perioperative myocardial injury
大体时间：From the end of surgery to 48 hours after surgery
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For patients with normal baseline cTn levels, a cTn elevation exceeding 5 times the 99th percentile upper reference limit (URL) within 48 hours after PCI .For patients with elevated baseline cTn levels, the post-procedural cTn value must increase by >20% from baseline, and the absolute post-procedural cTn value must exceed 5 times the 99th percentile upper reference limit (URL).
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From the end of surgery to 48 hours after surgery
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Composite outcome at 30 days after PCI
大体时间：30 days after surgery
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Consisting of: (1) myocardial infarction; (2) new-onset stroke or transient ischemic attack (TIA); (3) all-cause death; and (4) any unplanned revascularization.
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30 days after surgery
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Blood pressure stability
大体时间：From the start of the procedure to the end of the procedure
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Quantified by the absolute real variability of perioperative generalized mean arterial pressure (ARV-MAP). Calculation procedures are as follows: ① For continuous arterial blood pressure waveform data, calculate the mean MAP for each non-overlapping 15-minute time window. ② Compute the absolute value of the difference between the mean MAP of every pair of adjacent time windows. ③ Sum all these absolute values, then divide the total sum by the total observation duration (operative time). A lower ARV-MAP value indicates smaller temporal fluctuations in MAP, meaning more stable blood pressure. |
From the start of the procedure to the end of the procedure
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Perioperative myocardial oxygen consumption
大体时间：From the start of the procedure to the end of the procedure
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Rate-pressure product (RPP) = heart rate (beats per minute) × systolic blood pressure (mmHg).
Blood pressure and heart rate are recorded every 15 minutes after patients enter the operating room, and the mean value of RPP is calculated.
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From the start of the procedure to the end of the procedure
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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住院时长
大体时间：通过患者出院，平均为术后2天
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住院时间
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通过患者出院，平均为术后2天
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住院费用
大体时间：术后平均出院时间为2天
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住院费用
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术后平均出院时间为2天
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术中低血压
大体时间：从干预开始到手术结束
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收缩压<90 mmHg或较基线降低>30%
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从干预开始到手术结束
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术中低氧血症的发生率
大体时间：从干预至手术结束
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血氧饱和度 <90% 持续至少30秒
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从干预至手术结束
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Incidence of unplanned hospital readmission within 30 days after surgery
大体时间：30 days after surgery
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Unplanned hospital readmission
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30 days after surgery
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Change in perioperative anxiety scores
大体时间：Before intervention; after intervention but before surgery; 1 day after surgery
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Anxiety was also assessed using the Perioperative Anxiety Scale-7 (PAS-7) , which ranges from 0 to 28, with higher scores indicating greater anxiety.
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Before intervention; after intervention but before surgery; 1 day after surgery
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Sleep quality scores on postoperative day 1
大体时间：Baseline, 1 day after surgery
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Sleep quality was assessed using the Richards Campbell Sleep Questionnaire (RCSQ), RCSQ uses a visual analog scale ranging from 0 to 100 for each item, where 0 represents the worst possible sleep condition (or the most negative description) and 100 represents the best possible sleep condition (or the most positive description).
Patients are asked to place a slider at the position that best describes their sleep status the previous night.
The total RCSQ sleep score is calculated as the mean of the first five items (Items 6-10).
The sixth item (Item 11) assesses noise level and is scored separately.
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Baseline, 1 day after surgery
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Postoperative pain scores
大体时间：Immediately after surgery
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Pain was assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating more severe pain.
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Immediately after surgery
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Quality of life scores at 30 days after surgery
大体时间：30 days after surgery
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Quality of life was assessed using the EuroQol Five-Dimensional Questionnaire (EQ-5D) EuroQol Five-Dimensional Questionnaire (EQ-5D): The EQ-5D includes a visual analog scale (EQ-VAS) ranging from 0 to 100, where higher scores indicate better health status. |
30 days after surgery
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Quality of life scores at 30 days after surgery
大体时间：30 days after surgery
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Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Kansas City Cardiomyopathy Questionnaire (KCCQ): The KCCQ consists of 23 items that quantify the following domains: physical limitations, symptoms (including symptom frequency, severity, and change over time), self-efficacy, social function, and quality of life. The total score ranges from 0 to 100, with higher scores representing better quality of life. |
30 days after surgery
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Acute adverse reactions
大体时间：From intervention to 6 hours after surgery
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drug reaction
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From intervention to 6 hours after surgery
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Incidence of severe bradycardia
大体时间：From intervention to 6 hours after surgery
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Heart rate <40 beats/min
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From intervention to 6 hours after surgery
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Dosage of vasoactive agents
大体时间：From intervention to 6 hours after surgery
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Including atropine, norepinephrine and nitroglycerin
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From intervention to 6 hours after surgery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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