Independent Research Group Clinical Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany
Chair of Epidemiology at UNIKA-T, Ludwig-Maximilians-Universitat Munchen, Augsburg, Germany.
BMJ Open. 2019 Oct 28;9(10):e031411. doi: 10.1136/bmjopen-2019-031411.
Acute pulmonary embolism (PE) is a frequent life-threatening event and an important cause of hospitalisation, morbidity and mortality worldwide. Limited information on the long-term course of PE patients is available so far. The Lungenembolie Augsburg study will provide a view on the predisposing and PE-provoking factors, diagnostic procedures and short as well as long-term treatment options. Especially, the data on the long-term course of the disease-in combination with omics data obtained in biospecimens-will generate new knowledge regarding triggers, disease progression, treatment, long-term sequelae, prognosis and prevention of disease recurrence.
In this prospective study, we will include about 1000 patients admitted to the university hospital of Augsburg, aged 18 years and older with a confirmed diagnosis of acute PE. At baseline, demographic information, symptoms on presentation, delay in diagnosis, predisposing and PE-provoking factors, comorbidity, quality of life, symptoms of anxiety and depression, information on invasive and non-invasive treatment procedures, complications and laboratory parameters will be collected. During the hospital stay, 30 mL blood will be collected from the patients, processed, aliquoted and frozen at -80°C. In a subgroup of patients, an eight-channel polygraphy will be carried out to assess sleep-disordered breathing. All study participants will be followed up for 60 months via postal questionnaires or telephone interviews after hospital discharge. Long-term survival, bleeding complications and PE recurrence during the follow-up are the primary study outcomes. To identify risk factors and determinants associated with these outcomes, confounder-adjusted Cox-regressions will be used for modelling and to estimate relative risks. Effect modification by age and sex will be examined.
The study protocol was approved by the Ethics Committee of the Ludwig-Maximilians-Universität München (Date of approval: 1 August 2017, Reference number: 17-378). Study results will be presented at national and international conferences and published in peer-reviewed scientific journals.
急性肺栓塞（PE）是一种常见的危及生命的事件，也是全球住院、发病率和死亡率的重要原因。目前，关于 PE 患者的长期病程的信息有限。奥格斯堡肺栓塞研究将提供有关易患因素和 PE 诱发因素、诊断程序以及短期和长期治疗选择的观点。特别是，关于疾病长期病程的数据——结合生物标本中获得的组学数据——将产生关于疾病进展、治疗、长期后遗症、预后和预防疾病复发的新认识。
在这项前瞻性研究中，我们将纳入约 1000 名年龄在 18 岁及以上、确诊为急性 PE 的入住奥格斯堡大学医院的患者。在基线时，将收集人口统计学信息、就诊时的症状、诊断延迟、易患因素和 PE 诱发因素、合并症、生活质量、焦虑和抑郁症状、侵入性和非侵入性治疗程序信息、并发症和实验室参数。在住院期间，将从患者身上采集 30 毫升血液，进行处理、分装并在-80°C 下冷冻。在患者亚组中，将进行八通道多导睡眠图检查以评估睡眠呼吸障碍。所有研究参与者将在出院后通过邮寄问卷或电话访谈进行 60 个月的随访。长期生存、出血并发症和随访期间的 PE 复发是主要的研究结果。为了确定与这些结果相关的风险因素和决定因素，将使用调整混杂因素的 Cox 回归进行建模，并估计相对风险。将检查年龄和性别对效应修饰的影响。
该研究方案已获得慕尼黑路德维希-马克西米利安大学伦理委员会的批准（批准日期：2017 年 8 月 1 日，参考号：17-378）。研究结果将在国内和国际会议上进行报告，并发表在同行评议的科学期刊上。
