FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease

April 1, 2024 updated by: Ayesha Zia, University of Texas Southwestern Medical Center

FUVID Study: A Multi-center, Prospective Study Evaluating Exercise Intolerance and Dyspnea on Exertion in Patients Following First-episode Deep Venous Thrombosis and Pulmonary Embolism

This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects will be identified from the clinical setting and approached to participate in this observational study where participants will be enrolled at 3 different sites and referred from several more sites and have: cardiopulmonary exercise testing and pulmonary function testing at The Institute of Exercise and Environmental Medicine (IEEM), UTSW Exercise Facility, Cardiac MRI and MRI for pulmonary perfusion at Children's Medical Center and MR Spectroscopy and MR for Muscle Perfusion at the Advanced Imaging Research Center (AIRC) performed in Dallas over a 3 day research visit at week 12 and Month 12. Blood is collected for biomarkers at these visits and multiple questionnaires are completed by participants.

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Research Institute (ACRI)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shelley Crary, MD
    • Florida
      • Saint Petersburg, Florida, United States, 33701
    • Georgia
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Massachusetts
    • Michigan
      • Mount Pleasant, Michigan, United States, 48859
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Principal Investigator:
          • Lauren Amos, MD
        • Contact:
        • Contact:
    • Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Recruiting
        • Children's Hospital of Philadelphia
        • Principal Investigator:
          • Leslie Raffini, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hilary Whitworth, MD
    • Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Study population will include children (defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted), and patients (defined as individuals in a clinical setting with whom there is a treatment relationship).

Participants must meet the eligibility criteria in order to participate in this trial.

Description

Inclusion Criteria:

  • Ages 8 to ≤ 21 years
  • Participant must be able to speak and understand English
  • Be willing to participate and able to comply with the study protocol
  • For participants with PE: Children with acute, radiologically confirmed pulmonary embolism (PE) with our without DVT
  • For control group: Cohort 1: Children who are prescribed physical activity restrictions for 2 up to 12 weeks following any minor outpatient surgery or, minor injury (surgery or injury is referred to as "diagnosis" hereafter) Cohort 2: Children who are not prescribed physical activity restrictions and are otherwise considered to be healthy.

Exclusion Criteria:

  • Congenital heart disease with abnormal pulmonary circulation or with in-situ pulmonary artery thrombosis
  • Chronic kidney disease
  • Chronic inflammatory or an autoimmune disorder (such as systemic lupus erythematosus, juvenile rheumatoid disorder, inflammatory bowel disease, and sickle cell disease)
  • A metabolic or endocrinological disorder such as diabetes mellitus or thyroid disorder
  • History of or active cancer
  • Pregnant
  • Musculoskeletal limitations to exercise expected to be present uptil 4 months post-diagnosis
  • Weight ≥ 300 lbs
  • Contraindications to magnetic resonance imaging
  • Frequent severe exacerbations of asthma defined by two or more bursts of systemic glucocorticoids (more than three days each) in the previous year or at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year. Patients should also be excluded if there are daily symptoms of asthma requiring daily use of short-acting bronchodilators such as albuterol or levalbuterol administration. The use of controller medications such as daily inhaled corticosteroids for mild persistent asthma is not exclusionary.
  • Has any other medical condition, which in the opinion of the investigator may potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical study

Additional exclusion criteria for participants with PE:

  • Prior history of DVT or PE (upper extremity, cerebral sinus venous thrombosis and abdominal thromboses encountered as a neonate are not exclusion criteria)
  • Lack of anticoagulant treatment for the acute VTE due to contraindications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Pulmonary Embolism
The target accrual is based on the primary endpoint (exercise intolerance and dyspnea on exertion). To achieve adequate power and precision in the primary analysis, the target enrollment is 80 children. Both males and females of all races and ethnic groups are eligible for this study.
Diagnostic test: Blood draw (Visit 1)
Labs will be drawn at Visit 1, also referred to as screening (within 60 days of diagnosis) with the standard of care labs drawn.
Diagnostic test: Blood draw (Visits 2 and 3)
Labs will be drawn at Visit 2 (12 weeks post-diagnosis with a range of 10-16 weeks) and Visit 3 (12 months ± 30 days) for research purposes only and will be collected at Children's Medical Center and processed at UT Southwestern Medical Center.
Control Group
A positive control group that has not had pulmonary embolism (PE) but is prescribed physical activity restrictions expected to produce a similar deconditioning effect as patients with PE will be enrolled from UT Southwestern only (cohort 1) or children who are no prescribed physical activity restrictions and are otherwise considered healthy (cohort 2). The target accrual of the positive control group is based on feasibility and availability of funds and will be limited to 25 controls.
Diagnostic test: Blood draw (Visits 2 and 3)
Labs will be drawn at Visit 2 (12 weeks post-diagnosis with a range of 10-16 weeks) and Visit 3 (12 months ± 30 days) for research purposes only and will be collected at Children's Medical Center and processed at UT Southwestern Medical Center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in exercise capacity
Time Frame: 3 months and 12 months post-diagnosis
Measured objectively by peak oxygen uptake (VO2) as a percent predicted based on ml/min/kg of lean body mass during cardiopulmonary exercise testing (CPET)
3 months and 12 months post-diagnosis
Change in dyspnea on exertion (DOE)
Time Frame: 3 months and 12 months post-diagnosis
measured using Borg questionnaire and defined as a mean difference of > 1 between those with and without exercise intolerance at the end of the warm-up and submaximal work rates during CPET
3 months and 12 months post-diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiac maladaptation
Time Frame: 3 months and 12 months post-diagnosis
Measured as ventriculo-arterial coupling ratio in response to exercise (change in Ea/Emax from rest to peak intensity exercise) during exercise cardiac magnetic resonance imaging (MRI)
3 months and 12 months post-diagnosis
Change in pulmonary/ventilatory limitations
Time Frame: 3 months and 12 months post-diagnosis
Measured as VE/VCO2 in participants with and without exercise intolerance during cardiopulmonary testing
3 months and 12 months post-diagnosis
Change in muscle metabolic aberrations
Time Frame: 3 months and 12 months post-diagnosis
Measured by % phosphocreatine (PCr) depletion (Δ %PCr) during exercise using 31P magnetic resonance spectroscopy on 7 Tesla in participants with and without exercise intolerance
3 months and 12 months post-diagnosis
Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Quantitative assessment)
Time Frame: At diagnosis, 3 months and 12 months post-diagnosis
Quantitative Assessment: Measured using Qanadli Index scale (range 0-40; 0=minimum score and 40=maximum score) at pulmonary embolism diagnosis and 3 months post-diagnosis.
At diagnosis, 3 months and 12 months post-diagnosis
Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Qualitative assessment)
Time Frame: At diagnosis, 3 months and 12 months post-diagnosis
Qualitative Assessment: Measured using pulmonary perfusion maps at diagnosis, 3 and 12 months post-diagnosis. Since qualitative, there are no minimum or maximum values.
At diagnosis, 3 months and 12 months post-diagnosis
Change in calf muscle perfusion and venous flow in participants with and without exercise intolerance and between affected and non-affected extremity
Time Frame: 3 months and 12 months post-diagnosis
Measured using extremity arterial spin labelling on 7 Tesla MRI
3 months and 12 months post-diagnosis
Change in dyspnea ratings using Dalhousie Pictorial Scale
Time Frame: 3 months and 12 months post-diagnosis

Measured at rest, fatigue, and post-exercise in participants with and without exercise intolerance

Dalhousie Pictorial Scale measuring Dyspnea and Perceived Exertion (minimum score=4; maximum score=28; higher score means worse dyspnea)
3 months and 12 months post-diagnosis
Change in dyspnea ratings using Borg Dyspnea Scale
Time Frame: 3 months and 12 months post-diagnosis

Measured at rest, fatigue, and post-exercise in participants with and without exercise intolerance

Borg Dyspnea Scale (minimum score=0; maximum score=10; higher score means worse dyspnea)
3 months and 12 months post-diagnosis
Change in dyspnea ratings using Dyspnoea-12 Scale
Time Frame: 3 months and 12 months post-diagnosis

Measured at rest, fatigue, and post-exercise in participants with and without exercise intolerance

Dyspnoea-12 Scale (minimum score=0; maximum score=36; higher score means worse dyspnea)
3 months and 12 months post-diagnosis
Change in dyspnea ratings using Modified Medical Research Council Dyspnea Scale
Time Frame: 3 months and 12 months post-diagnosis

Measured at rest, fatigue, and post-exercise in participants with and without exercise intolerance

Modified Medical Research Council Dyspnea Scale (minimum score=0; maximum score=4; higher score means worse dyspnea)
3 months and 12 months post-diagnosis
Change in inflammatory cytokine biomarker - High-sensitivity CRP
Time Frame: At diagnosis, 3 months and 12 months post-diagnosis
Measure inflammatory cytokine biomarker high-sensitivity CRP (unit of measure: mg/L) in participants with and without exercise intolerance
At diagnosis, 3 months and 12 months post-diagnosis
Change in inflammatory cytokine biomarkers - IL-6 and TNF
Time Frame: At diagnosis, 3 months and 12 months post-diagnosis
Measure inflammatory cytokine biomarkers IL-6 and TNF-α (unit of measure: pg/mL) in participants with and without exercise intolerance
At diagnosis, 3 months and 12 months post-diagnosis
Change in coagulation biomarker - D-dimer
Time Frame: At diagnosis, 3 months and 12 months post-diagnosis
Measure coagulation biomarker D-dimer (unit of measure: ng/mL) in participants with and without exercise intolerance
At diagnosis, 3 months and 12 months post-diagnosis
Change in coagulation biomarker - Thrombin generation
Time Frame: At diagnosis, 3 months and 12 months post-diagnosis
Measure coagulation biomarker thrombin generation (unit of measure: nM·min) in participants with and without exercise intolerance
At diagnosis, 3 months and 12 months post-diagnosis
Change in coagulation biomarker - Fibrinolysis assay
Time Frame: At diagnosis, 3 months and 12 months post-diagnosis
Measure coagulation biomarker fibrinolysis assay (unit of measure: % lysis) in participants with and without exercise intolerance
At diagnosis, 3 months and 12 months post-diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Ayesha Zia, MD, MSCS, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 12, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2020-0868

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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