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

NCT04294849 | Terminated

• 1 other identifier: STU-2019-1406
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Deep Vein Thrombosis; Pulmonary Embolism

Outcome Measures

Primary Outcomes (5)

• 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.

Secondary Outcomes (5)

• Exercise Intolerance

  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

  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

  Participants will be asked to fill this questionnaires 4 weeks after diagnosis, and 3-6 months after diagnosis.

• OSA-18 Sleep Apnea Questionnaire

  Participants will be asked to fill out this questionnaire at one month post diagnosis.

• PHQ-9 Questionnaire

  Participants will be asked to fill this questionnaire one month after diagnosis.

Study Arms (1)

Venous Thromboembolism Arm

EXPERIMENTAL

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

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

Interventions

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

Venous Thromboembolism Arm

Bicycle Ergometry OTHER

To measure peak VO2 as a representation of global aerobic fitness

Venous Thromboembolism Arm

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

Venous Thromboembolism Arm

Questionnaires BEHAVIORAL

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

Venous Thromboembolism Arm

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 8- ≤ 21 years old AND
• Lower extremity deep venous thrombosis OR
• Lower extremity deep venous thrombosis AND pulmonary embolism OR
• Pulmonary Embolism

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center / Children's Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

Magnetic Resonance Spectroscopy; Exercise Test; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ayesha Zia, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: March 4, 2020
• Study Start: February 6, 2020
• Primary Completion: February 14, 2022
• Study Completion: February 16, 2022
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

US (1)