Exercise Intolerance and Skeletal Muscle Bioenergetics in Children With Deep Venous Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Inflammatory markers
研究概览
简要总结
This is a prospective cohort study of 30 patients who are 8-21 years of age with venous thromboembolism (VTE)- either lower extremity deep venous thrombosis (DVT) or pulmonary embolism (PE).
详细描述
Participants will be in three groups- those with lower extremity DVT, those with PE, or those with both lower extremity DVT and PE. Patients will have blood drawn for thrombin generation assay, thromboelastography assay, and thromboinflammatory panel in addition to standard of care labs for diagnosis of VTE and management of anticoagulation. The patients will then fill out questionnaires on quality of life and level of exercise at their first outpatient visit 4 weeks after diagnosis. At approximately 3-6 months after diagnosis, patients will undergo two days of testing for the research study. All patients will have exercise testing using bicycle ergometry to measure global aerobic fitness. They will once again fill out questionnaires about their quality of life and level of physical activity. After a 24 hour rest period, DVT patients will undergo 31P-MR Spectroscopy and non-invasive spin labeling MRI to provide data on skeletal muscle bioenergetics (phosphocreatine metabolism), and lymphatic and venous flow respectively in the affected leg compared to the unaffected leg. This will allow each patient to be his or her own control. After these research procedures, patients will continue to receive standard of care treatment for their VTE in the Bleeding and Thrombosis clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- 否
入选标准
- •Age 8- ≤ 21 years old AND
- •Lower extremity deep venous thrombosis OR
- •Lower extremity deep venous thrombosis AND pulmonary embolism OR
- •Pulmonary Embolism
排除标准
- •Contraindications to exercise, such as post-surgical patients with cast immobility or fractures
- •Patients unable to follow instructions/commands at baseline due to developmental delay
- •Patients with congenital heart disease and abnormal pulmonary circulation/perfusion
- •Contraindications to undergoing magnetic resonance imaging
结局指标
主要结局
Inflammatory markers
时间窗: Diagnosis to 4 weeks.
A custom blood assay will be used to assess inflammation at the time of the thrombotic event. Assay will include measurements of IL-6, IL-8, TNF-alpha, CRP, IL-10, IL-6 receptor, TNF alpha receptors.
Coagulation markers
时间窗: Diagnosis to 4 weeks.
Thrombin generation assay (TGA) will be used to assess hypercoagulability, and thromboelastography will be used to assess fibrinolysis. These will be drawn at the time of the thrombotic event.
Phosphocreatine Depletion and Recovery
时间窗: 31P MR Spectroscopy will be performed one time between 3-6 months after diagnosis.
Phosphocreatine (PCr) will be measured at baseline, during performance of submaximal exercise to fatigue and then at rest in the 31 P MR Spectroscopy Scan.
Assessment for Venous Occlusion
时间窗: Arterial Spin labeling MRI will be performed one time between 3-6 months after diagnosis.
Arterial spin labeling MRI will be utilized to examine venous flow in bilateral lower extremities to assess for venous occlusion.
Assessment of Lymphatic flow
时间窗: Arterial Spin labeling MRI will be performed one time between 3-6 months after diagnosis
Arterial spin labeling MRI will be utilized to assess lymphatic flow in bilateral lower extremities to assess for adequate lymphatic drainage.
次要结局
- Exercise Intolerance(Pulmonary embolism patients will undergo this testing at 4-6 weeks after diagnosis. Deep venous thrombosis only patients will undergo testing at 3 months.)
- Godin Leisure Time Activity Questionnaire(Questionnaire to be filled out to assess activity at baseline, then one month after diagnosis, and 3-6 months after diagnosis.)
- Pediatric Venous Quality of Life Questionnaire(Participants will be asked to fill this questionnaires 4 weeks after diagnosis, and 3-6 months after diagnosis.)
- OSA-18 Sleep Apnea Questionnaire(Participants will be asked to fill out this questionnaire at one month post diagnosis.)
- PHQ-9 Questionnaire(Participants will be asked to fill this questionnaire one month after diagnosis.)
研究者
Ayesha Zia
Assistant Professor
University of Texas Southwestern Medical Center