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

NCT04294849 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-11-15

No results posted yet for this study

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

Interventions

OTHER

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

OTHER

Bicycle Ergometry

To measure peak VO2 as a representation of global aerobic fitness

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

BEHAVIORAL

Questionnaires

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

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Ayesha Zia, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-06
Primary Completion
2022-02-14
Completion
2022-02-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294849 on ClinicalTrials.gov