Clinical trial NCT04294849: Exercise Intolerance and Skeletal Muscle Bioenergetics in Children With Deep Venous Thrombosis
Official title: Exercise Intolerance and Skeletal Muscle Bioenergetics in Children With Deep Venous Thrombosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 5
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Phosphocreatine Depletion and Recovery
timeFrame: 31P MR Spectroscopy will be performed one time between 3-6 months after diagnosis.
measure: Assessment for Venous Occlusion
timeFrame: Arterial Spin labeling MRI will be performed one time between 3-6 months after diagnosis.
measure: Assessment of Lymphatic flow
timeFrame: Arterial Spin labeling MRI will be performed one time between 3-6 months after diagnosis
measure: Inflammatory markers
timeFrame: Diagnosis to 4 weeks.
measure: Coagulation markers
timeFrame: Diagnosis to 4 weeks.
Secondary outcomes:
measure: Exercise Intolerance
timeFrame: Pulmonary embolism patients will undergo this testing at 4-6 weeks after diagnosis. Deep venous thrombosis only patients will undergo testing at 3 months.
measure: Godin Leisure Time Activity Questionnaire
timeFrame: Questionnaire to be filled out to assess activity at baseline, then one month after diagnosis, and 3-6 months after diagnosis.
measure: Pediatric Venous Quality of Life Questionnaire
timeFrame: Participants will be asked to fill this questionnaires 4 weeks after diagnosis, and 3-6 months after diagnosis.
measure: OSA-18 Sleep Apnea Questionnaire
timeFrame: Participants will be asked to fill out this questionnaire at one month post diagnosis.
measure: PHQ-9 Questionnaire
timeFrame: Participants will be asked to fill this questionnaire one month after diagnosis.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center / Children's Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Ayesha Zia, MD
role: PRINCIPAL_INVESTIGATOR
References: