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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY
This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 21
Healthy Volunteers: t
View:
• 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.
Locations
United States
Arkansas
Arkansas Childrens Research Institute (ACRI)
RECRUITING
Little Rock
Florida
Johns Hopkins All Childrens Hospital
RECRUITING
St. Petersburg
Georgia
Emory University / Children's Heathcare Atlanta
RECRUITING
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Michigan
Central Michigan University
RECRUITING
Mount Pleasant
Missouri
Childrens Mercy Hospital
RECRUITING
Kansas City
Ohio
Cincinnati Childrens Hospital
RECRUITING
Cincinnati
Nationwide Children's Hospital
RECRUITING
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
UT Southwestern Medical Center / Children's Medical Center
RECRUITING
Dallas
Cook Childrens Medical Center
RECRUITING
Fort Worth
Texas Children's Hospital
RECRUITING
Houston
Contact Information
Primary
Ayesha Zia, MD, MSCS
Ayesha.Zia@utsouthwestern.edu
214-456-7000
Backup
Sonja Stutzman, PhD
Sonja.Stutzman@UTSouthwestern.edu
214-648-7762
Time Frame
Start Date: 2020-12-22
Estimated Completion Date: 2026-12
Participants
Target number of participants: 125
Treatments
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.
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center