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

NCT ID: NCT04294849

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-06
• Study Completion Date: 2022-02-16

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.

Conditions

Deep Vein Thrombosis; Pulmonary Embolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Venous Thromboembolism Arm

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: 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

Bicycle Ergometry

Intervention Type: OTHER

To measure peak VO2 as a representation of global aerobic fitness

Lab Panel

Intervention Type: 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

Intervention Type: BEHAVIORAL

A. Dalhousie Dyspnea Scale B. Godin Leisure Time Exercise Questionnaire C. Pediatric Venous Quality of Life Questionnaire

Interventions

Magnetic Resonance Imaging

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

Intervention Type: OTHER

Bicycle Ergometry

To measure peak VO2 as a representation of global aerobic fitness

Intervention Type: OTHER

Lab Panel

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

Intervention Type: OTHER

Questionnaires

A. Dalhousie Dyspnea Scale B. Godin Leisure Time Exercise Questionnaire C. Pediatric Venous Quality of Life Questionnaire

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ayesha Zia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayesha Zia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

UT Southwestern Medical Center / Children's Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2019-1406

Identifier Type: -

Identifier Source: org_study_id