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荷兰侵入性冠状动脉血管舒缩功能检测登记研究(NL-CFT)的设计与原理。

Design and rationale of the NetherLands registry of invasive Coronary vasomotor Function Testing (NL-CFT).

机构信息

Dept. of Cardiology, Radboudumc, Nijmegen, the Netherlands.

Dept. of Cardiology, Amsterdam UMC, location Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

出版信息

Int J Cardiol. 2023 May 15;379:1-8. doi: 10.1016/j.ijcard.2023.02.043. Epub 2023 Feb 28.

Abstract

BACKGROUND

Angina without angiographic evidence of obstructive coronary artery disease (ANOCA) is a highly prevalent condition with insufficient pathophysiological knowledge and lack of evidence-based medical therapies. This affects ANOCA patients prognosis, their healthcare utilization and quality of life. In current guidelines, performing a coronary function test (CFT) is recommended to identify a specific vasomotor dysfunction endotype. The NetherLands registry of invasive Coronary vasomotor Function testing (NL-CFT) has been designed to collect data on ANOCA patients undergoing CFT in the Netherlands.

METHODS

The NL-CFT is a web-based, prospective, observational registry including all consecutive ANOCA patients undergoing clinically indicated CFT in participating centers throughout the Netherlands. Data on medical history, procedural data and (patient reported) outcomes are gathered. The implementation of a common CFT protocol in all participating hospitals promotes an equal diagnostic strategy and ensures representation of the entire ANOCA population. A CFT is performed after ruling out obstructive coronary artery disease. It comprises of both acetylcholine vasoreactivity testing as well as bolus thermodilution assessment of microvascular function. Optionally, continuous thermodilution or Doppler flow measurements can be performed. Participating centers can perform research using own data, or pooled data will be made available upon specific request via a secure digital research environment, after approval of a steering committee.

CONCLUSION

NL-CFT will be an important registry by enabling both observational and registry based (randomized) clinical trials in ANOCA patients undergoing CFT.

摘要

背景

无造影阻塞性冠状动脉疾病证据的心绞痛(ANOCA)是一种高发疾病,其病理生理学知识不足,缺乏循证医学治疗方法。这会影响到ANOCA 患者的预后、医疗保健利用情况和生活质量。在当前的指南中,建议进行冠状动脉功能测试(CFT)以确定特定的血管运动功能障碍表型。荷兰侵袭性冠状动脉血管运动功能测试登记处(NL-CFT)旨在收集在荷兰进行 CFT 的 ANOCA 患者的数据。

方法

NL-CFT 是一个基于网络的、前瞻性、观察性登记处,包括荷兰所有参与中心接受临床指征 CFT 的连续 ANOCA 患者。收集病史、程序数据和(患者报告)结果数据。在所有参与医院实施共同的 CFT 方案可促进平等的诊断策略,并确保代表整个 ANOCA 人群。在排除阻塞性冠状动脉疾病后进行 CFT。它包括乙酰胆碱血管反应性测试以及微血管功能的热稀释评估。可选地,可以进行连续热稀释或多普勒流量测量。参与中心可以使用自己的数据进行研究,或者在特定请求下,经指导委员会批准后,通过安全的数字研究环境提供汇总数据。

结论

NL-CFT 将是一个重要的登记处,它可以在接受 CFT 的 ANOCA 患者中进行观察性和基于登记的(随机)临床试验。

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