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

The University of Texas System (UT)

Status: Terminated

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Treatments: Other: Magnetic Resonance Imaging; Other: Lab Panel; Other: Bicycle Ergometry; Behavioral: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT04294849

STU-2019-1406

Details and patient eligibility

About

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).

Full 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. After these research procedures, patients will continue to receive standard of care treatment for their VTE in the Bleeding and Thrombosis clinic.

Enrollment: 5 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Contraindications to undergoing magnetic resonance imaging

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Venous Thromboembolism Arm

Experimental group

Description:

This will be a cohort of patients age 8- ≤ 21 years old with objectively diagnosed DVT and/or PE.

Treatment:

Behavioral: Questionnaires

Other: Lab Panel

Other: Bicycle Ergometry

Other: Magnetic Resonance Imaging