Not provided
Not provided
Not provided
Not provided
Not provided
Study enrollment ceased because this was enrolling as a pilot study until a larger study (FUVID) was submitted, approved and received funding.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venous Thromboembolism Arm | Experimental | This will be a cohort of patients age 8- ≤ 21 years old with objectively diagnosed DVT and/or PE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Other | A. Phosphorous 31 MR Spectroscopy to evaluate skeletal muscle metabolism via measurement of depletion and recovery of phosphocreatine (PCr) B. Non-invasive arterial spin labeling MRI to evaluate lymphatic flow velocities and venous flow |
| Measure | Description | Time Frame |
|---|---|---|
| Phosphocreatine Depletion and Recovery | 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. | 31P MR Spectroscopy will be performed one time between 3-6 months after diagnosis. |
| Assessment for Venous Occlusion | Arterial spin labeling MRI will be utilized to examine venous flow in bilateral lower extremities to assess for venous occlusion. | Arterial Spin labeling MRI will be performed one time between 3-6 months after diagnosis. |
| Assessment of Lymphatic flow | Arterial spin labeling MRI will be utilized to assess lymphatic flow in bilateral lower extremities to assess for adequate lymphatic drainage. | Arterial Spin labeling MRI will be performed one time between 3-6 months after diagnosis |
| Inflammatory markers | 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. | Diagnosis to 4 weeks. |
| Coagulation markers | 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. | Diagnosis to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Intolerance | Participants will undergo Cardiopulmonary Exercise testing to assess maximal aerobic fitness. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ayesha Zia, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center / Children's Medical Center | Dallas | Texas | 75235 | United States |
Not provided
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D005080 | Exercise Test |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D006334 | Heart Function Tests |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bicycle Ergometry | Other | To measure peak VO2 as a representation of global aerobic fitness |
|
| Lab Panel | Other | A. Inflammatory lab panel (IL-6, IL-8, TNF alpha, P-selectin, high sensitivity CRP, IL-6 receptor, TNF R1/R2) drawn at diagnosis B. Thrombin Generation Assay to measure hypercoagulability and Thromboelastography prior to initiating anticoagulation |
|
| Questionnaires | Behavioral | A. Dalhousie Dyspnea Scale B. Godin Leisure Time Exercise Questionnaire C. Pediatric Venous Quality of Life Questionnaire |
|
Patients will be asked to fill out a questionnaire to determine levels of physical activity for comparison at different time points throughout treatment. |
| 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 | Questionnaire to determine quality of life in various areas including school, leisure time, home, and relationships with peers. | Participants will be asked to fill this questionnaires 4 weeks after diagnosis, and 3-6 months after diagnosis. |
| OSA-18 Sleep Apnea Questionnaire | Patients will be asked to complete this questionnaire to assess sleep quality and screen for obstructive sleep apnea. | Participants will be asked to fill out this questionnaire at one month post diagnosis. |
| PHQ-9 Questionnaire | Participants will fill out this questionnaire to screen for depression. | Participants will be asked to fill this questionnaire one month after diagnosis. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |