Clinical trial NCT04583878: FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deep Venous Thrombosis
Pulmonary Embolism
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 125
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in exercise capacity
timeFrame: 3 months and 12 months post-diagnosis
measure: Change in dyspnea on exertion (DOE)
timeFrame: 3 months and 12 months post-diagnosis
Secondary outcomes:
measure: Change in cardiac maladaptation
timeFrame: 3 months and 12 months post-diagnosis
measure: Change in pulmonary/ventilatory limitations
timeFrame: 3 months and 12 months post-diagnosis
measure: Change in muscle metabolic aberrations
timeFrame: 3 months and 12 months post-diagnosis
measure: Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Quantitative assessment)
timeFrame: At diagnosis, 3 months and 12 months post-diagnosis
measure: Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Qualitative assessment)
timeFrame: At diagnosis, 3 months and 12 months post-diagnosis
measure: Change in calf muscle perfusion and venous flow in participants with and without exercise intolerance and between affected and non-affected extremity
timeFrame: 3 months and 12 months post-diagnosis
measure: Change in dyspnea ratings using Dalhousie Pictorial Scale
timeFrame: 3 months and 12 months post-diagnosis
measure: Change in dyspnea ratings using Borg Dyspnea Scale
timeFrame: 3 months and 12 months post-diagnosis
measure: Change in dyspnea ratings using Dyspnoea-12 Scale
timeFrame: 3 months and 12 months post-diagnosis
measure: Change in dyspnea ratings using Modified Medical Research Council Dyspnea Scale
timeFrame: 3 months and 12 months post-diagnosis
measure: Change in inflammatory cytokine biomarker - High-sensitivity CRP
timeFrame: At diagnosis, 3 months and 12 months post-diagnosis
measure: Change in inflammatory cytokine biomarkers - IL-6 and TNF
timeFrame: At diagnosis, 3 months and 12 months post-diagnosis
measure: Change in coagulation biomarker - D-dimer
timeFrame: At diagnosis, 3 months and 12 months post-diagnosis
measure: Change in coagulation biomarker - Thrombin generation
timeFrame: At diagnosis, 3 months and 12 months post-diagnosis
measure: Change in coagulation biomarker - Fibrinolysis assay
timeFrame: At diagnosis, 3 months and 12 months post-diagnosis
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Childrens Research Institute (ACRI)
state: Arkansas
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Childrens Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University / Children's Heathcare Atlanta
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Mount Pleasant
country: United States
facility: Central Michigan University
state: Michigan
city: Kansas City
country: United States
facility: Childrens Mercy Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center / Children's Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Cook Childrens Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Ayesha Zia, MD, MSCS
role: PRINCIPAL_INVESTIGATOR
References: