确定肺动脉高血压中心脏MRI终点的最小重要差异
Samer Alabed1,2,3, Pankaj Garg4, Faisal Alandejani5
1Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK s.alabed@nhs.net.
The European respiratory journal
|July 6, 2023
概括
这项研究定义了肺动脉高血压 (PAH) 患者的心脏磁共振 (CMR) 度量最小重要差异 (MID). 这些MID有助于根据患者的福祉,功能和生存来评估治疗的有效性.
科学领域:
- 心脏病学 心脏病学
- 医疗成像医学成像
- 肺高血压研究 肺高血压研究
背景情况:
- 心脏磁共振 (CMR) 是双心室评估的黄金标准.
- 关于CMR指标的最小重要差异 (MID) 的数据有限,这阻碍了它们作为临床终点的使用.
- 美国食品和药物管理局的建议强调以患者为中心的结果 ("感觉,功能,生存").
研究的目的:
- 在肺动脉高血压 (PAH) 患者中确定CMR指标的MID.
- 为了使CMR指标与患者报告的结果和临床状态保持一致.
- 支持CMR作为PAH试验中临床结果测量的作用.
主要方法:
- 追溯分析254名先前未接受治疗的PAH患者,两次CMR扫描 (基线和12个月).
- 采用了经过验证的自动细分工具进行心脏测量.
- 采用基于分布和基于的方法,将CMR变化与EmPHasis-10联系起来,增量穿步行测试和1年死亡率.
主要成果:
- 在RV喷射分数增加5%和RV体积减少17mL意味着改善.
- 在RV喷射分数下降5%和RV体积增加10毫升表明情况恶化.
- 为CMR指标建立了MID,反映了患者的"感觉,功能或生存".
结论:
- 这项研究确定了PAH中CMR的临床相关MID.
- 这些MID支持CMR作为临床结果衡量的实用性.
- 结果将有助于计算未来基于CMR的临床试验的样本大小.
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