Exercise Intolerance and Skeletal Muscle Bioenergetics in Children With Deep Venous Thrombosis

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    30
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 25 January 2021
thrombosis
clot
thrombin
dyspnea
venous thromboembolism
deep vein thrombosis
thromboembolism
embolism
anticoagulation therapy
thromboelastography
venous thrombosis
deep venous thrombosis of lower extremity
dvts

Summary

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).

Description

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. If initial imaging is obtained at 3 months, patients may be asked to undergo repeat imaging (MR spectroscopy and non-invasive spin labeling MRI) at 6 months pending funding availability. After these research procedures, patients will continue to receive standard of care treatment for their VTE in the Bleeding and Thrombosis clinic.

Details
Condition Pulmonary Disease, Venous Thrombosis, Pulmonary Embolism, Thrombosis, Blood Clots, Lung Disease, Deep Vein Thrombosis, deep venous thrombosis of lower extremity, deep venous thrombosis, lung embolism
Treatment magnetic resonance imaging, Questionnaires, Bicycle Ergometry, Lab Panel
Clinical Study IdentifierNCT04294849
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 8 yrs and 21 yrs?
Gender: Male or Female
Do you have any of these conditions: Venous Thrombosis or Pulmonary Embolism or Pulmonary Disease or Blood Clots or Deep Vein Thrombosis or Thrombosis or Lung Disease?
Do you have any of these conditions: Deep Vein Thrombosis or Pulmonary Embolism or deep venous thrombosis or Thrombosis or lung embolism or Blood Clots or Pulmonary Disease or Venous Thro...?
Age 8- 21 years old AND
Lower extremity deep venous thrombosis OR
Lower extremity deep venous thrombosis AND pulmonary embolism OR
Pulmonary Embolism

Exclusion Criteria

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
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