Venous Thromboembolism Sequelae in a Population-based Inception Cohort

基于人群的初始队列中的静脉血栓栓塞后遗症

基本信息

批准号：
10556744
负责人：
Laura Brienne Harrington
金额：
$ 85.33万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-06-01 至 2028-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10556744
关键词：
Accelerometer Acute Adult Age American American Heart Association Anticoagulants Anticoagulation Area Attention Biological Markers Blood Blood coagulation Brain natriuretic peptide Cardiovascular system Cessation of life Chronic Clinical Cohort Studies Collection Consent Data Data Collection Deep Vein Thrombosis Development Dimensions Dyspnea Electronic Health Record Eligibility Determination Enrollment Etiology Event Fibrin fragment D Future Heart Rate Hemostatic function Impairment Individual Integrated Delivery of Health Care International Intervention Joints Knowledge Measurable Measurement Measures Mental Health Methods Oral Outcome Pain Patient-Focused Outcomes Patients Pattern Physical activity Population Population Study Postphlebitic Syndrome Prevalence Prognosis Pulmonary Embolism Quality of life Recurrence Rehabilitation therapy Research Research Personnel Research Support Rest Risk Risk Factors Risk Reduction Shortness of Breath Societies Specific qualifier value Surveys Swelling Symptoms System Thrombosis Time Troponin Veins Virulence Factors Vitamin K Washington Wrist adverse outcome antagonist biobank cohort common symptom epidemiology study experience follow-up functional status high risk high risk population improved insight interest member modifiable risk novel pharmacologic physical conditioning population based post intervention prevent programs prospective recruit venous thromboembolism

项目摘要

PROJECT SUMMARY / ABSTRACT Nearly 1 million Americans each year experience a first venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). VTE is typically viewed as an acute event that is treatable by anticoagulants, with less focus on chronic adverse VTE sequelae or on rehabilitation. Adults who have experienced an incident VTE may be at high risk for adverse VTE sequelae in the first 12 months after their event, including patient-relevant symptoms (such as dyspnea, pain, and swelling) and adverse clinical outcomes (VTE recurrence and death). Research to-date has characterized the post-thrombotic syndrome occurring post-DVT, but there has been much less attention given to sequelae following an incident PE. Furthermore, almost all research about sequelae after both DVT and PE has been in the context of anticoagulation with vitamin K antagonists rather than with newer direct oral anticoagulants (DOACs), which are now primarily used in practice. Clinically, we lack methods to identify adults at greatest risk of adverse VTE sequelae and how to prevent these sequelae. Whether several promising biomarkers that are readily available for clinical measurement (brain natriuretic peptide, D-dimer, and troponin), or, whether modifiable exposures such as anticoagulant type or physical activity are associated with adverse VTE sequelae is incompletely understood. In the proposed research, we will characterize patient-relevant symptoms and adverse clinical outcomes at multiple timepoints in the first 12 months post-VTE and will evaluate biomarkers and modifiable risk factors in relation to these VTE sequelae. To accomplish this, we will create a new prospective population- based inception cohort study based in Kaiser Permanente Washington, an integrated healthcare delivery system in Washington State. Our preliminary research supports the feasibility of daily identification of incident VTE cases among adult enrollees, and we anticipate ~957 eligible adults with validated VTE across 33 months of enrollment. De novo data collection in ~380 consenting adults will include: 1) surveys at 2 weeks and 1, 3, 6, and 12 months post-VTE to collect information on post-VTE symptoms, 2) wrist-worn accelerometers to objectively measure physical activity and resting heart rate in the 12 months post-VTE, and 3) blood collection within 4 weeks of the incident VTE to measure 3 pre-specified biomarkers. These study data will be combined with rich electronic health record data to accomplish 3 scientific aims: (1) Characterize the prevalence pattern of symptoms at 2 weeks and 1, 3, 6, and 12 months post-incident VTE and clinical outcomes over the 12 months of follow-up; (2) evaluate the associations of key biomarker levels measured in blood collected within 4 weeks of the incident VTE; and, (3) evaluate modifiable risk factors for sequalae, including VTE anticoagulant type and physical activity level. This research will fill critical knowledge gaps that are important to patients by providing estimates of the prevalence of clinically burdensome VTE sequelae and identifying possible etiologic and modifiable risk factors that can be targeted in future interventions.

项目摘要 /摘要每年有近100万美国人体验第一个静脉血栓栓塞（VTE），其中包括深静脉血栓形成（DVT）和肺栓塞（PE）。 VTE通常被视为一个急性事件可以通过抗凝剂治疗，更少关注慢性不良VTE后遗症或康复。成年人经历了事件的VTE可能有不良VTE后遗症的高风险他们的事件，包括与患者相关的症状（例如呼吸困难，疼痛和肿胀）和不良临床结果（VTE复发和死亡）。迄今为止的研究表征了血栓形成综合征发生后DVT发生，但是在事件PE后，对后遗症的关注较少。此外，DVT和PE之后几乎所有关于后遗症的研究都在维生素K拮抗剂抗凝剂，而不是与较新的直接口服抗凝剂（DOAC）的抗凝作用现在主要用于实践。在临床上，我们缺乏识别最大风险的成年人的方法后遗症以及如何预防这些后遗症。是否容易获得几种有希望的生物标志物用于临床测量（脑坚脂肽，D-二聚体和肌钙蛋白），或者是否可修改暴露例如抗凝类型或体育活动与不良VTE后遗症有关理解。在拟议的研究中，我们将表征与患者相关的症状和不良临床 VTE后的前12个月的多个时间点的结果，并将评估生物标志物和可修改与这些VTE后遗症有关的危险因素。为此，我们将创建一个新的预期人群 - 基于综合医疗保健服务的Kaiser Permanente Washington的基于Inception Cohort研究华盛顿州的系统。我们的初步研究支持日常识别事件的可行性成人参与者中的VTE病例，我们预计在33个月中有验证的VTE有约957名合格的成年人入学人数。〜380名同意成年人的从头数据收集将包括：1）2周和1、3、6，1、3、6， VTE后12个月收集有关VTE症状的信息，2）腕上戴上加速度计在VTE后12个月内客观地衡量体育活动和静息心率，3）血液收集在事件发生后的4周内，VTE测量了3个预先指定的生物标志物。这些研究数据将结合在一起通过丰富的电子健康记录数据来完成3个科学目的：（1）表征流行模式在12周和12个月后VTE和12个月的症状和12个月的临床结果随访月；（2）评估在4次内收集的血液中测得的关键生物标志物水平的关联事件的数周; （3）评估频段的可修改风险因素，包括VTE抗凝剂类型和体育锻炼水平。这项研究将填补对患者重要的关键知识空白提供对临床负担重的VTE后遗症患病率的估计并确定可能的病因以及可以在以后的干预措施中针对的可修改风险因素。