无症状 AS 随机队列中的 MRI
早期瓣膜置换术对无症状主动脉瓣狭窄心肌瘢痕的影响：随机队列的观察性 MRI 研究
研究概览
详细说明
正在进行的随机对照试验 (RCT) 正在测试早期 AVR 治疗无症状严重主动脉瓣狭窄的策略（“严重无症状主动脉瓣狭窄的早期手术”：EASY-AS 和“无症状严重主动脉瓣狭窄患者左心室失代偿生物标志物指导的早期瓣膜置换术”主动脉瓣狭窄：进化），如果呈阳性，则有可能将干预的时机转移到早期疾病。 随着 TAVR 最近被证明在低风险（主要是有症状的患者）中不劣于 SAVR，这也有可能扩展到无症状的患者。
MRI 研究表明，高达 50% 的无症状 AS 患者已经有疤痕 (LGE)，即使在 AVE 后也只能部分逆转，并且仍然是死亡率的标志。 尚不清楚早期瓣膜置换术是否会减少心肌内的疤痕负担。
患者报告的结果测量 (PROM) 越来越被认为是手术的重要结果测量，特别是在老年人群中，对于他们来说，生存率的显着提高既不可能，也不是患者所寻求的。 世界卫生组织残疾评估附表 2 (WHODAS-2) 是一种标准化的跨文化衡量标准，用于评估主要生活领域的功能和残疾的健康状况，已被证明是评估残疾的有效且可靠的工具。 对接受心力衰竭药物治疗的患者的 PROMS 仪器进行的全面正式审查得出结论，Euroqol (EQ5D) 和明尼苏达心力衰竭患者生活问卷 (MLHFQ) 最适合衡量该组的生活质量。 Euroqol 是欧洲最常用的通用仪器，在 AVR 后 1 年显示严重 AS 有所改善。 MLHFQ 是一种心血管疾病特异性工具，已被证明对接受瓣膜手术的患者的治疗干预可靠、有效且反应灵敏。 了解干预对 PROM 的影响有助于共同决策，并有助于形成未来的个性化建议。
这项前瞻性、观察性机制研究将最大限度地利用正在进行的随机对照试验提供的机会，以尝试确定两种治疗策略（早期与晚期 AVR）对心脏逆向重构（特别是纤维化负担）、PROM 和围手术期恢复的影响。
研究类型
注册 (实际的)
联系人和位置
学习地点
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Leicestershire
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Leicester、Leicestershire、英国、LE3 9QP
- Glenfield Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
取样方法
研究人群
描述
纳入标准：
- 愿意并能够同意
- 随机对照试验的参与者将无症状严重 AS 患者随机分配至早期 AVR 与标准治疗
- 根据原始试验的纳入标准定义的严重主动脉瓣狭窄
- 在随机对照试验中随机化时无症状
- 愿意进行 1-2 次心脏 MRI 扫描
排除标准：
- MRI 的禁忌症。
- 肾小球滤过率 <30。
- 严重的幽闭恐惧症（排除 MRI）。
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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早期主动脉瓣置换术
无症状的重度主动脉瓣狭窄患者随机接受早期主动脉瓣置换术
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干预的选择将由当地临床团队做出。
作为主要 EASY/EVOLVED 试验的一部分，干预的时间将由随机化决定
|
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标准护理
无症状的重度主动脉瓣狭窄患者被随机分配到“观察等待”直至症状出现。
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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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Total amount of fibrosis (measured by LGE on MRI) in those randomised to early AVR vs standard care.
大体时间：2 years
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Measured by percentage of late gadolinium enhancement on MRI, between those randomised to early AVR vs standard care.
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
两组围手术期恢复情况差异。
大体时间：手术之日起30天
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手术后 30 天内在家的天数
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手术之日起30天
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Differences in patient reported outcome measures (health related quality of life) between the two groups
大体时间：2 years
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Measured using the questionnaire EuroQol- 5 (EQ-5D-5L) EuroQol- 5 Dimension is a standardised measure of health-related quality of life and consists of 2 pages. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. |
2 years
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Differences in patient reported outcome measures (patient perceptions of living with heart failure) between the two groups
大体时间：2 years
|
Measured using the Minnesota Living with Heart Failure questionnaire (MLHF) Minnesota Living with Heart Failure questionnaire aids to systematically and comprehensively assess the patient's perceptions of the effects of heart failure and its treatment on his or her daily life. It is a 21-item paper self- administered questionnaire designed as a measure of heart failure, as indicated by its adverse effects on patients' lives. The MLHFQ quantifies a single overall score as a measure of the impact of heart failure on the patient's life. |
2 years
|
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Differences in patient reported outcome measures (in assessing functioning and disability in major life domains) between the two groups
大体时间：2 years
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Measured using the World Health Organisation Disability Assessment Schedule-2 (WHODAS-2) questionnaire World Health Organisation Disability Assessment Schedule-2 (WHODAS-2) is a standardised cross-cultural measurement of health status assessing functioning and disability in major life domains, that has been shown to be a valid and reliable instrument for assessment of disability. It is a 36-item measure that assesses disability in adults age 18 years and older. |
2 years
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Differences in reverse remodelling (by left ventricular volume) between the two groups.
大体时间：2 years
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LV end-diastolic volume index in ml/m2
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2 years
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Differences in reverse remodelling (by left ventricular mass) between the two groups.
大体时间：2 years
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LV mass index in g/m2
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2 years
|
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Differences in reverse remodelling (by left ventricular mass/volume) between the two groups.
大体时间：2 years
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LV mass/volume ratio
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2 years
|
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Differences in reverse remodelling (by left ventricular ejection fraction) between the two groups.
大体时间：2 years
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LV ejection fraction in %
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2 years
|
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Differences in reverse remodelling (by myocardial perfusion reserve) between the two groups.
大体时间：2 years
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Myocardial perfusion reserve (in those having optional stress perfusion)
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2 years
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合作者和调查者
调查人员
- 首席研究员：Anvesha Singh, Dr、University of Leicester
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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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