Deep Vein ThrombosisNCT04294849
Exercise Intolerance and Skeletal Muscle Bioenergetics in Children With Deep Venous Thrombosis
A study testing Magnetic Resonance Imaging, Bicycle Ergometry and Lab Panel in people with Deep Vein Thrombosis and Pulmonary Embolism, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a prospective cohort study of 30 patients who are 8-21 years of age with venous thromboembolism (VTE)- either lower extremity deep venous thrombosis (DVT) or pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism
- What is being tested?
- Magnetic Resonance Imaging, Bicycle Ergometry and Lab Panel
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 16 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8- ≤ 21 years old AND
- Lower extremity deep venous thrombosis OR
- Lower extremity deep venous thrombosis AND pulmonary embolism OR
- Pulmonary Embolism
Who cannot join
- Contraindications to exercise, such as post-surgical patients with cast immobility or fractures
- Patients unable to follow instructions/commands at baseline due to developmental delay
- Patients with congenital heart disease and abnormal pulmonary circulation/perfusion
- Contraindications to undergoing magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center / Children's Medical Center
Dallas, Texas, 75235
About this study
This is a prospective cohort study of 30 patients who are 8-21 years of age with venous thromboembolism (VTE)- either lower extremity deep venous thrombosis (DVT) or pulmonary embolism (PE).
Read the detailed description
Participants will be in three groups- those with lower extremity DVT, those with PE, or those with both lower extremity DVT and PE. Patients will have blood drawn for thrombin generation assay, thromboelastography assay, and thromboinflammatory panel in addition to standard of care labs for diagnosis of VTE and management of anticoagulation. The patients will then fill out questionnaires on quality of life and level of exercise at their first outpatient visit 4 weeks after diagnosis. At approximately 3-6 months after diagnosis, patients will undergo two days of testing for the research study. All patients will have exercise testing using bicycle ergometry to measure global aerobic fitness. They will once again fill out questionnaires about their quality of life and level of physical activity. After a 24 hour rest period, DVT patients will undergo 31P-MR Spectroscopy and non-invasive spin labeling MRI to provide data on skeletal muscle bioenergetics (phosphocreatine metabolism), and lymphatic and venous flow respectively in the affected leg compared to the unaffected leg. This will allow each patient to be his or her own control. After these research procedures, patients will continue to receive standard of care treatment for their VTE in the Bleeding and Thrombosis clinic.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Being tested
- Magnetic Resonance Imaging, Bicycle Ergometry, Lab Panel, Questionnaires
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
- Phosphorous 31 MR Spectroscopy to evaluate skeletal muscle metabolism via measurement of depletion and recovery of phosphocreatine (PCr) B. Non-invasive arterial spin labeling MRI to evaluate lymphatic flow velocities and venous flow
Bicycle ErgometryOther
To measure peak VO2 as a representation of global aerobic fitness
Lab PanelOther
- Inflammatory lab panel (IL-6, IL-8, TNF alpha, P-selectin, high sensitivity CRP, IL-6 receptor, TNF R1/R2) drawn at diagnosis B. Thrombin Generation Assay to measure hypercoagulability and Thromboelastography prior to initiating anticoagulation
QuestionnairesBehavioural
- Dalhousie Dyspnea Scale B. Godin Leisure Time Exercise Questionnaire C. Pediatric Venous Quality of Life Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Venous Thromboembolism Arm | Experimental | This will be a cohort of patients age 8- ≤ 21 years old with objectively diagnosed DVT and/or PE. Receives: Other: Magnetic Resonance Imaging; Other: Bicycle Ergometry; Other: Lab Panel; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphocreatine Depletion and Recovery
Phosphocreatine (PCr) will be measured at baseline, during performance of submaximal exercise to fatigue and then at rest in the 31 P MR Spectroscopy Scan.
Measured: 31P MR Spectroscopy will be performed one time between 3-6 months after diagnosis.
Assessment for Venous Occlusion
Arterial spin labeling MRI will be utilized to examine venous flow in bilateral lower extremities to assess for venous occlusion.
Measured: Arterial Spin labeling MRI will be performed one time between 3-6 months after diagnosis.
Assessment of Lymphatic flow
Arterial spin labeling MRI will be utilized to assess lymphatic flow in bilateral lower extremities to assess for adequate lymphatic drainage.
Measured: Arterial Spin labeling MRI will be performed one time between 3-6 months after diagnosis
Inflammatory markers
A custom blood assay will be used to assess inflammation at the time of the thrombotic event. Assay will include measurements of IL-6, IL-8, TNF-alpha, CRP, IL-10, IL-6 receptor, TNF alpha receptors.
Measured: Diagnosis to 4 weeks.
Coagulation markers
Thrombin generation assay (TGA) will be used to assess hypercoagulability, and thromboelastography will be used to assess fibrinolysis. These will be drawn at the time of the thrombotic event.
Measured: Diagnosis to 4 weeks.
Secondary outcomes (5)
Exercise Intolerance
Participants will undergo Cardiopulmonary Exercise testing to assess maximal aerobic fitness.
Measured: Pulmonary embolism patients will undergo this testing at 4-6 weeks after diagnosis. Deep venous thrombosis only patients will undergo testing at 3 months.
Godin Leisure Time Activity Questionnaire
Patients will be asked to fill out a questionnaire to determine levels of physical activity for comparison at different time points throughout treatment.
Measured: Questionnaire to be filled out to assess activity at baseline, then one month after diagnosis, and 3-6 months after diagnosis.
Pediatric Venous Quality of Life Questionnaire
Questionnaire to determine quality of life in various areas including school, leisure time, home, and relationships with peers.
Measured: Participants will be asked to fill this questionnaires 4 weeks after diagnosis, and 3-6 months after diagnosis.
OSA-18 Sleep Apnea Questionnaire
Patients will be asked to complete this questionnaire to assess sleep quality and screen for obstructive sleep apnea.
Measured: Participants will be asked to fill out this questionnaire at one month post diagnosis.
PHQ-9 Questionnaire
Participants will fill out this questionnaire to screen for depression.
Measured: Participants will be asked to fill this questionnaire one month after diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start6 Feb 2020
- Primary completion14 Feb 2022
- Study completion16 Feb 2022
Why it stopped: Study enrollment ceased because this was enrolling as a pilot study until a larger study (FUVID) was submitted, approved and received funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Zia, University of Texas Southwestern Medical Center
- Investigators
- Ayesha Zia, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294849
- Sponsor's protocol ID
- STU-2019-1406
- Status last verified
- Nov 2024
- First submitted
- 13 Feb 2020
- Last updated
- 15 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intolerance and Skeletal Muscle Bioenergetics in Children With Deep Venous Thrombosis
- ClinicalTrials.gov ID
- NCT04294849
- Acronym / sponsor ID
- STU-2019-1406
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment ceased because this was enrolling as a pilot study until a larger study (FUVID) was submitted, approved and received funding.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective cohort study of 30 patients who are 8-21 years of age with venous thromboembolism (VTE)- either lower extremity deep venous thrombosis (DVT) or pulmonary embolism (PE).
Detailed description
Participants will be in three groups- those with lower extremity DVT, those with PE, or those with both lower extremity DVT and PE. Patients will have blood drawn for thrombin generation assay, thromboelastography assay, and thromboinflammatory panel in addition to standard of care labs for diagnosis of VTE and management of anticoagulation. The patients will then fill out questionnaires on quality of life and level of exercise at their first outpatient visit 4 weeks after diagnosis. At approximately 3-6 months after diagnosis, patients will undergo two days of testing for the research study. All patients will have exercise testing using bicycle ergometry to measure global aerobic fitness. They will once again fill out questionnaires about their quality of life and level of physical activity. After a 24 hour rest period, DVT patients will undergo 31P-MR Spectroscopy and non-invasive spin labeling MRI to provide data on skeletal muscle bioenergetics (phosphocreatine metabolism), and lymphatic and venous flow respectively in the affected leg compared to the unaffected leg. This will allow each patient to be his or her own control. After these research procedures, patients will continue to receive standard of care treatment for their VTE in the Bleeding and Thrombosis clinic.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venous Thromboembolism Arm | Experimental | Other: Magnetic Resonance Imaging, Other: Bicycle Ergometry, Other: Lab Panel, Behavioral: QuestionnairesThis will be a cohort of patients age 8- ≤ 21 years old with objectively diagnosed DVT and/or PE. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 8- ≤ 21 years old AND
- Lower extremity deep venous thrombosis OR
- Lower extremity deep venous thrombosis AND pulmonary embolism OR
- Pulmonary Embolism
Key exclusion criteria (4 listed)
- Contraindications to exercise, such as post-surgical patients with cast immobility or fractures
- Patients unable to follow instructions/commands at baseline due to developmental delay
- Patients with congenital heart disease and abnormal pulmonary circulation/perfusion
- Contraindications to undergoing magnetic resonance imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingA. Phosphorous 31 MR Spectroscopy to evaluate skeletal muscle metabolism via measurement of depletion and recovery of phosphocreatine (PCr) B. Non-invasive arterial spin labeling MRI to evaluate lymphatic flow velocities and venous flow | Other | Venous Thromboembolism Arm |
| Bicycle ErgometryTo measure peak VO2 as a representation of global aerobic fitness | Other | Venous Thromboembolism Arm |
| Lab PanelA. Inflammatory lab panel (IL-6, IL-8, TNF alpha, P-selectin, high sensitivity CRP, IL-6 receptor, TNF R1/R2) drawn at diagnosis B. Thrombin Generation Assay to measure hypercoagulability and Thromboelastography prior to initiating anticoagulation | Other | Venous Thromboembolism Arm |
| QuestionnairesA. Dalhousie Dyspnea Scale B. Godin Leisure Time Exercise Questionnaire C. Pediatric Venous Quality of Life Questionnaire | Behavioural | Venous Thromboembolism Arm |
Primary outcome
Phosphocreatine Depletion and Recovery
Time frame: 31P MR Spectroscopy will be performed one time between 3-6 months after diagnosis.
Phosphocreatine (PCr) will be measured at baseline, during performance of submaximal exercise to fatigue and then at rest in the 31 P MR Spectroscopy Scan.
Assessment for Venous Occlusion
Time frame: Arterial Spin labeling MRI will be performed one time between 3-6 months after diagnosis.
Arterial spin labeling MRI will be utilized to examine venous flow in bilateral lower extremities to assess for venous occlusion.
Assessment of Lymphatic flow
Time frame: Arterial Spin labeling MRI will be performed one time between 3-6 months after diagnosis
Arterial spin labeling MRI will be utilized to assess lymphatic flow in bilateral lower extremities to assess for adequate lymphatic drainage.
Inflammatory markers
Time frame: Diagnosis to 4 weeks.
A custom blood assay will be used to assess inflammation at the time of the thrombotic event. Assay will include measurements of IL-6, IL-8, TNF-alpha, CRP, IL-10, IL-6 receptor, TNF alpha receptors.
Coagulation markers
Time frame: Diagnosis to 4 weeks.
Thrombin generation assay (TGA) will be used to assess hypercoagulability, and thromboelastography will be used to assess fibrinolysis. These will be drawn at the time of the thrombotic event.
5 secondary outcomes
Exercise Intolerance
Time frame: Pulmonary embolism patients will undergo this testing at 4-6 weeks after diagnosis. Deep venous thrombosis only patients will undergo testing at 3 months.
Godin Leisure Time Activity Questionnaire
Time frame: Questionnaire to be filled out to assess activity at baseline, then one month after diagnosis, and 3-6 months after diagnosis.
Pediatric Venous Quality of Life Questionnaire
Time frame: Participants will be asked to fill this questionnaires 4 weeks after diagnosis, and 3-6 months after diagnosis.
OSA-18 Sleep Apnea Questionnaire
Time frame: Participants will be asked to fill out this questionnaire at one month post diagnosis.
PHQ-9 Questionnaire
Time frame: Participants will be asked to fill this questionnaire one month after diagnosis.
Results and safety
The study was stopped early (reason given: Study enrollment ceased because this was enrolling as a pilot study until a larger study (FUVID) was submitted, approved and received funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Zia, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging, Bicycle Ergometry and Lab Panel in people with Deep Vein Thrombosis and Pulmonary Embolism, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study enrollment ceased because this was enrolling as a pilot study until a larger study (FUVID) was submitted, approved and received funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phosphocreatine Depletion and Recovery (time frame: 31P MR Spectroscopy will be performed one time between 3-6 months after diagnosis.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.