FUVID Study: A Multi-center, Prospective Study Evaluating Exercise Intolerance and Dyspnea on Exertion in Patients Following First-episode Deep Venous Thrombosis and Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 115
- 试验地点
- 14
- 主要终点
- Change in dyspnea on exertion (DOE)
研究概览
简要总结
This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
详细描述
Subjects will be identified from the clinical setting and approached to participate in this observational study where participants will be enrolled at 3 different sites and referred from several more sites and have: cardiopulmonary exercise testing and pulmonary function testing at The Institute of Exercise and Environmental Medicine (IEEM), UTSW Exercise Facility, Cardiac MRI and MRI for pulmonary perfusion at Children's Medical Center and MR Spectroscopy and MR for Muscle Perfusion at the Advanced Imaging Research Center (AIRC) performed in Dallas over a 3 day research visit at week 12 and Month 12. Blood is collected for biomarkers at these visits and multiple questionnaires are completed by participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 8 to ≤ 21 years
- •Participant must be able to speak and understand English
- •Be willing to participate and able to comply with the study protocol
- •For participants with PE: Children with acute, radiologically confirmed pulmonary embolism (PE) with our without DVT
- •For control group: Cohort 1: Children who are prescribed physical activity restrictions for 2 up to 12 weeks following any minor outpatient surgery or, minor injury (surgery or injury is referred to as "diagnosis" hereafter) Cohort 2: Children who are not prescribed physical activity restrictions and are otherwise considered to be healthy.
排除标准
- •Congenital heart disease with abnormal pulmonary circulation or with in-situ pulmonary artery thrombosis
- •Chronic kidney disease
- •Chronic inflammatory or an autoimmune disorder (such as systemic lupus erythematosus, juvenile rheumatoid disorder, inflammatory bowel disease, and sickle cell disease)
- •A metabolic or endocrinological disorder such as diabetes mellitus or thyroid disorder
- •History of or active cancer
- •Musculoskeletal limitations to exercise expected to be present uptil 4 months post-diagnosis
- •Weight ≥ 300 lbs
- •Contraindications to magnetic resonance imaging
- •Frequent severe exacerbations of asthma defined by two or more bursts of systemic glucocorticoids (more than three days each) in the previous year or at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year. Patients should also be excluded if there are daily symptoms of asthma requiring daily use of short-acting bronchodilators such as albuterol or levalbuterol administration. The use of controller medications such as daily inhaled corticosteroids for mild persistent asthma is not exclusionary.
- •Has any other medical condition, which in the opinion of the investigator may potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical study
- •Additional exclusion criteria for participants with PE:
- •Prior history of DVT or PE (upper extremity, cerebral sinus venous thrombosis and abdominal thromboses encountered as a neonate are not exclusion criteria)
- •Lack of anticoagulant treatment for the acute VTE due to contraindications
研究组 & 干预措施
Participants with Pulmonary Embolism
The target accrual is based on the primary endpoint (exercise intolerance and dyspnea on exertion). To achieve adequate power and precision in the primary analysis, the target enrollment is 80 children. Both males and females of all races and ethnic groups are eligible for this study.
干预措施: Blood draw (Visit 1) (Diagnostic Test)
Participants with Pulmonary Embolism
The target accrual is based on the primary endpoint (exercise intolerance and dyspnea on exertion). To achieve adequate power and precision in the primary analysis, the target enrollment is 80 children. Both males and females of all races and ethnic groups are eligible for this study.
干预措施: Blood draw (Visits 2 and 3) (Diagnostic Test)
Control Group
A positive control group that has not had pulmonary embolism (PE) but is prescribed physical activity restrictions expected to produce a similar deconditioning effect as patients with PE will be enrolled from UT Southwestern only (cohort 1) or children who are no prescribed physical activity restrictions and are otherwise considered healthy (cohort 2). The target accrual of the positive control group is based on feasibility and availability of funds and will be limited to 25 controls.
干预措施: Blood draw (Visits 2 and 3) (Diagnostic Test)
结局指标
主要结局
Change in dyspnea on exertion (DOE)
时间窗: 3 months and 12 months post-diagnosis
measured using Borg questionnaire and defined as a mean difference of \> 1 between those with and without exercise intolerance at the end of the warm-up and submaximal work rates during CPET
Change in exercise capacity
时间窗: 3 months and 12 months post-diagnosis
Measured objectively by peak oxygen uptake (VO2) as a percent predicted based on ml/min/kg of lean body mass during cardiopulmonary exercise testing (CPET)
次要结局
- Change in dyspnea ratings using Borg Dyspnea Scale(3 months and 12 months post-diagnosis)
- Change in cardiac maladaptation(3 months and 12 months post-diagnosis)
- Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Qualitative assessment)(At diagnosis, 3 months and 12 months post-diagnosis)
- Change in calf muscle perfusion and venous flow in participants with and without exercise intolerance and between affected and non-affected extremity(3 months and 12 months post-diagnosis)
- Change in muscle metabolic aberrations(3 months and 12 months post-diagnosis)
- Change in dyspnea ratings using Modified Medical Research Council Dyspnea Scale(3 months and 12 months post-diagnosis)
- Change in coagulation biomarker - Fibrinolysis assay(At diagnosis, 3 months and 12 months post-diagnosis)
- Change in pulmonary/ventilatory limitations(3 months and 12 months post-diagnosis)
- Change in coagulation biomarker - Thrombin generation(At diagnosis, 3 months and 12 months post-diagnosis)
- Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Quantitative assessment)(At diagnosis, 3 months and 12 months post-diagnosis)
- Change in dyspnea ratings using Dalhousie Pictorial Scale(3 months and 12 months post-diagnosis)
- Change in dyspnea ratings using Dyspnoea-12 Scale(3 months and 12 months post-diagnosis)
- Change in coagulation biomarker - D-dimer(At diagnosis, 3 months and 12 months post-diagnosis)
- Change in inflammatory cytokine biomarker - High-sensitivity CRP(At diagnosis, 3 months and 12 months post-diagnosis)
- Change in inflammatory cytokine biomarkers - IL-6 and TNF(At diagnosis, 3 months and 12 months post-diagnosis)
研究者
Ayesha Zia
Associate Professor of Pediatrics
University of Texas Southwestern Medical Center