ACTIVE_NOT_RECRUITING

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

Conditions

Deep Venous Thrombosis Pulmonary Embolism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2020-12-22

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04583878

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.

Ages Eligible for Study:8 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	* 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 * 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

Inclusion Criteria

Exclusion 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.

* 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
* 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

Contacts and Locations

Principal Investigator

Ayesha Zia, MD, MSCS

PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Study Locations (Sites)

Arkansas Childrens Research Institute (ACRI)

Little Rock, Arkansas, 72202

United States

Johns Hopkins All Childrens Hospital

St. Petersburg, Florida, 33701

United States

Emory University / Children's Heathcare Atlanta

Atlanta, Georgia, 30329

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

Central Michigan University

Mount Pleasant, Michigan, 48859

United States

Childrens Mercy Hospital

Kansas City, Missouri, 64108

United States

Cincinnati Childrens Hospital

Cincinnati, Ohio, 45229

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146

United States

UT Southwestern Medical Center / Children's Medical Center

Dallas, Texas, 75235

United States

Cook Childrens Medical Center

Fort Worth, Texas, 76104

United States

Texas Children's Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Ayesha Zia, MD, MSCS, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

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 Registration Dates

Study Start Date2020-12-22

Study Completion Date2026-12

Study Record Updates

Study Start Date2020-12-22

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Deep Venous Thrombosis
Pulmonary Embolism