Blood draw (Visit 1)
Diagnostic TestLabs will be drawn at Visit 1, also referred to as screening (within 60 days of diagnosis) with the standard of care labs drawn.
NCT Number: NCT04583878
This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
This study is active but is not currently recruiting participants.
8 year–21 year
All sexes
Observational
Arkansas Childrens Research Institute (ACRI), Little Rock, Arkansas, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additional exclusion criteria for participants with PE:
Labs will be drawn at Visit 1, also referred to as screening (within 60 days of diagnosis) with the standard of care labs drawn.
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.
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)
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
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)
Time frame: 3 months and 12 months post-diagnosis
Measured as VE/VCO2 in participants with and without exercise intolerance during cardiopulmonary testing
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
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.
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.
Time frame: 3 months and 12 months post-diagnosis
Measured using extremity arterial spin labelling on 7 Tesla MRI
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)
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)
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)
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)
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
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
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
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
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
University of Texas Southwestern Medical Center
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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