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对TAVR的心声核实验室方法:一个跨大西洋的共识

Claire B Ren¹, Danielle Tardif², Hans-Jelle Brandenburg³

¹Cardialysis Clinical Trial Management and Core Laboratories, Rotterdam, the Netherlands; Department of Cardiology, Cardiovascular Institute, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.

JACC. Cardiovascular imaging

|July 6, 2024

概括

协调心声回声核心实验室 (ECL) 确保了跨导管大动脉置换 (TAVR) 试验的数据可互换性. 本综述详细介绍了一种成功的跨大西洋协调方法,并为最佳心声回声分析提供建议.

科学领域:

心脏病学心脏病学
医疗成像医学成像
临床试验临床试验

背景情况:

在多中心临床试验中,对数据的一致性至关重要.
超导管大动脉置换 (TAVR) 试验严重依赖于心声回声学终点,需要标准化分析.
ECL之间的变化可能会影响试验结果和监管部门的批准.

研究的目的:

描述一种统一的方法来分析不同ECL的TAVR后心声学终点.
评估ECL之间协调的可行性和可重复性.
确定ECL间变化的来源,并提供最佳图像采集和分析的建议.

主要方法:

审查了两个已建立的ECL之间的第一个跨大西洋协调经验.
门学术研究联盟3 (VARC-3) 对心声回声学终点的定义的应用.
分析ECL内部和ECL之间的可重复性.
根据已识别的可变性制定建议.

主要成果:

对TAVR心声回声终点进行ECL间协调的可行性已被证明.
评估了ECL内部和ECL间的可重复性,突出了潜在可变性的领域.
在心声回应分析中,确定了导致ECL间变异的根本原因.
提供了改善心声回声图像采集和判断的具体建议.

结论:

跨ECL协调是可以实现的,对于可靠的TAVR试验数据至关重要.
标准化的方法和明确的建议可以减轻ECL之间的变化.
成功的协调对未来TAVR试验的最佳实践,物流和监管方面有影响.

关键词:

一个主动脉动脉.核心实验室核心实验室超声心电图 (Echocardiography) 是一种心声回声仪.统一化和化统一化和化通过透气管导管进行过导管.

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