FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease (NCT04583878) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease
United States115 participantsStarted 2020-12-22
Plain-language summary
This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
Who can participate
Age range8 Years – 21 Years
SexALL
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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 prev…
What they're measuring
1
Change in exercise capacity
Timeframe: 3 months and 12 months post-diagnosis
2
Change in dyspnea on exertion (DOE)
Timeframe: 3 months and 12 months post-diagnosis
Trial details
NCT IDNCT04583878
SponsorUniversity of Texas Southwestern Medical Center