静脉血栓栓塞性疾病（FUVID）的功能特征研究：一项前瞻性、观察性、多中心研究的基本原理、设计和方法，以评估儿童肺栓塞后运动不耐受和呼吸困难的机制

IF 3.4 3区医学 Q2 HEMATOLOGY

Research and Practice in Thrombosis and Haemostasis Pub Date : 2025-01-01 DOI:10.1016/j.rpth.2024.102669

Ayesha Zia , Michael D. Nelson , Jimin Ren , Song Zhang , Robert F. Mattrey , Brian L. Han , Tarique Hussain , Joshua S. Greer , Manal Al-Qahtani , Kendra Malone , Sonja E. Stutzman , Deseray V. Sida , Sharon Primeaux , Marcela D. Torres , Clay T. Cohen , Shelley Crary , Jonathan Bernstein , Hilary B. Whitworth , Riten Kumar , Kisha A. Beg , Song Zhang PhD

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引用次数: 0

摘要

迄今为止，儿童肺栓塞（PE）的研究重点一直是PE复发和抗凝相关出血。虽然高度相关，但这些结果并没有完全反映功能限制和包括pe后综合征的心理影响。目的静脉血栓栓塞性疾病（FUVID）功能特征研究的主要目的是探讨儿童pe后综合征的机制。正在进行的FUVID研究将前瞻性招募并系统随访超过12个月，并进行标准化的肺、心脏和肌肉测试，纳入80例无合并症的首发PE患儿的多中心前瞻性队列。FUVID有2个主要结局：运动不耐受和运动性呼吸困难。运动不耐受将被客观地定义为在心肺运动测试中基于理想体重或每公斤瘦体重每分钟毫升数预测的峰值摄氧量百分比。使用Borg问卷客观量化呼吸困难，并将其定义为热身结束时的平均差值>；1和运动测试时的次最大工作速率，模拟日常生活中诱发呼吸困难的条件。相关的次要结局包括焦虑、抑郁和生活质量。结论：FUVID研究将通过客观测量，探讨同一患者在休息、亚极限运动（模拟日常生活活动）和极限运动时的症状（运动不耐受和运动性呼吸困难）与多种机制（血液动力学、通气或外周/肌肉）之间的关系。这将为选择患者进行长期随访提供新的证据，包括PE后的心理后遗症、随访方式，以及PE后功能限制的结果。

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The Functional Characterization of Venous Thromboembolic Disease (FUVID) study: rationale, design, and methods of a prospective, observational, multicenter study to evaluate mechanisms of exercise intolerance and dyspnea following pediatric pulmonary embolism

Background

To date, the focus of investigation in pediatric pulmonary embolism (PE) has been on PE recurrence and anticoagulant-related bleeding. While highly relevant, these outcomes do not fully capture functional limitations and the psychological impact that comprises post-PE syndrome.

Objectives

The primary objective of the Functional Characterization of Venous Thromboembolic Disease (FUVID) study was to investigate mechanisms of post-PE syndrome in children.

Methods

The ongoing FUVID study will prospectively enroll and systematically follow, over 12 months and with standardized pulmonary, cardiac, and muscle testing, a multicenter prospective cohort of 80 pediatric patients with first-episode PE without comorbidities. FUVID has 2 coprimary outcomes: exercise intolerance and exertional dyspnea. Exercise intolerance will be defined objectively as a percent predicted peak oxygen uptake based on ideal body weight or milliliters per minute per kilogram of lean body mass during cardiopulmonary exercise testing. Dyspnea will be objectively quantified using Borg questionnaires and defined as a mean difference of >1 at the end of the warm-up and submaximal work rates during exercise testing, simulating conditions during daily life that induce dyspnea. Pertinent secondary outcomes include anxiety, depression, and quality of life.

Conclusion

The FUVID study will investigate the relationship between symptoms (exercise intolerance and exertional dyspnea) and multiple mechanisms—hemodynamic, ventilatory, or peripheral/muscle—within the same patient at rest, submaximal exercise (simulating activities of daily living), and maximal exercise using objective measures. It will provide new evidence for selecting patients for long-term follow-up, including psychological sequelae, after PE, the modalities this follow-up should include, and the findings interpreted as indicating functional limitations after PE.

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