Venous Thrombosis Deep (Limbs)NCT05296499
EXERT: Exercise Physiology After Thrombosis
An observational study of Venous Thrombosis Deep (Limbs) and Post Thrombotic Syndrome, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Deep vein thrombosis (DVT) can cause long-term scarring and narrowing of veins. When there is extensive damage to the veins in the legs, groin or abdomen it can affect the way that blood is able to flow back up to the heart. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Thrombosis Deep (Limbs), Post Thrombotic Syndrome
- What is being tested?
- Cardiopulmonary exercise test (CPET), Exercise cardiac MRI and 6 minute walk test
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Sep 2019to 20 Apr 2023
- Phase
- Observational
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with previous deep vein thrombosis /chronic outflow obstruction in the iliofemoral veins and inferior vena cava.
Who may be able to join
- All groups:
- ->16 years of age
- Consent to participate in the research study and be willing to commit to study requirements, including completion of questionnaires and follow up visits.
- Group 1:
- Venous thrombosis/obstruction involving the inferior vena cava >12 months ago.
- Symptoms of exertional dyspnoea reported by patient.
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- Judged by the chief investigator as suitable for surgical intervention before recruitment to the study.
- Agree to adhere to therapeutic anticoagulation after surgical intervention.
- Group 2:
- Venous thrombosis/obstruction involving the inferior vena cava >12 months ago.
- Under the clinical care of the deep venous service for surveillance of symptoms.
- Group 3:
- Unilateral Iliofemoral venous thrombosis /obstruction >12 months ago.
- Judged by the chief investigator as suitable for surgical intervention before recruitment to the study.
- Agree to adhere to therapeutic anticoagulation after surgical intervention.
Who cannot join
- All groups:
- DVT or PE in last 12 months
- Significant or untreated left sided heart disease (eg coronary artery disease, LV dysfunction, valvular abnormalities, congenital heart disease, chronic or paroxysmal arrhythmias)
- Significant or untreated chronic lung disease (eg asthma, COPD, ILD)
- Moderate to severe renal disease
- Moderate to severe liver disease
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- Peripheral arterial disease
- Significant neurological or musculoskeletal disease
- Cognitive impairment or learning disabilities
- Pregnant or planning to become pregnant in next 12 months
- Active cancer (primary, metastatic or treated within last 6 months)
- Life expectancy < 2 years or chronic non-ambulatory status.
- Any other contraindication to exercise.
- Any contraindications to MRI scanning
- Inability to provide informed consent or comply with study assessments (e.g. due to cognitive impairment, physical limitations or geographic distance).
- Group 4:
- All of the above, plus:
- Previous DVT or PE
- Known, or clinical signs of chronic venous disease as judged by the chief investigator e.g. varicose veins, leg ulcers.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guys and St Thomas' NHS Foundation Trust
London, SE1 7EH
Rachael I Morris, MbChB, 02071889811, rachael.morris@kcl.ac.uk
Stephen Black, MD, 07810445772, stephen.black@kcl.ac.uk
About this study
Official title: Exercise Physiology After Thrombosis (EXERT): a Prospective Single Centre Cohort Study of Cardiovascular and Exercise Physiology in Patients With Previous Venous Thrombosis in the Inferior Vena Cava and Iliofemoral Veins.
Deep vein thrombosis (DVT) can cause long-term scarring and narrowing of veins. When there is extensive damage to the veins in the legs, groin or abdomen it can affect the way that blood is able to flow back up to the heart. Some patients are left with severe symptoms such as pain, leg swelling and ulcers, and have surgical treatment with nitinol stents to re-open the veins and relieve symptoms. The primary aim of this study is to investigate venous blood flow to the heart during exercise in patients with extensive damage to the veins in the groin and abdomen after DVT, and changes that happen after stenting.
Read the detailed description
Participants will have cardiopulmonary exercise testing, 6 minute walk test and basic blood tests to establish exercise tolerance and rule out other heart and lung conditions. Exercise cardiac MRI will be used to evaluate cardiac function during exercise. All participants will complete generic and disease specific quality of life questionnaires.
Participants who are having a stenting procedure will repeat assessments 6-8 weeks after surgery.
- Being tested
- Cardiopulmonary exercise test (CPET), Exercise cardiac MRI, 6 minute walk test, Blood tests, Quality of life questionnaires
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise test (CPET)Diagnostic test
Cardiopulmonary exercise testing using cycle ergonomenter
Exercise cardiac MRIDiagnostic test
Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET
6 minute walk testOther
6MWT
Blood testsDiagnostic test
FBC, U\&E, LFTS
Quality of life questionnairesOther
SF36, EQ5D, VEINES-QoL/Sym
Repeat baseline assessmentsOther
repeat baseline
MR venogramDiagnostic test
MRI scan of venous system
| Study group | Role | What they receive |
|---|---|---|
| Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea | Baseline assessments Post-operative assessments if applicable Receives: Diagnostic Test: Cardiopulmonary exercise test (CPET); Diagnostic Test: Exercise cardiac MRI; Other: 6 minute walk test; Diagnostic Test: Blood tests; Other: Quality of life questionnaires; Other: Repeat baseline assessments; Diagnostic Test: MR venogram | |
| Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea | Baseline assessments Post-operative assessments if applicable Receives: Diagnostic Test: Cardiopulmonary exercise test (CPET); Diagnostic Test: Exercise cardiac MRI; Other: 6 minute walk test; Diagnostic Test: Blood tests; Other: Quality of life questionnaires; Other: Repeat baseline assessments; Diagnostic Test: MR venogram | |
| Unilateral iliac venous outflow obstruction | Baseline assessments Post-operative assessments if applicable Receives: Diagnostic Test: Cardiopulmonary exercise test (CPET); Diagnostic Test: Exercise cardiac MRI; Other: 6 minute walk test; Diagnostic Test: Blood tests; Other: Quality of life questionnaires; Other: Repeat baseline assessments; Diagnostic Test: MR venogram | |
| Age and sex matched controls | Baseline assessments Receives: Diagnostic Test: Cardiopulmonary exercise test (CPET); Diagnostic Test: Exercise cardiac MRI; Other: 6 minute walk test; Other: Quality of life questionnaires; Other: Repeat baseline assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max after stenting
As determined by cardiopulmonary exercise testing
Measured: 6-8 weeks post surgery
Peak cardiac output during exercise
as determined by exercise cardiac MRI
Measured: 6-8 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start20 Sep 2019
- Primary completion20 Oct 2022 (estimated)
- Study completion20 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thrombosis Deep (Limbs)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296499
- Sponsor's protocol ID
- 254956
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Physiology After Thrombosis (EXERT): a Prospective Single Centre Cohort Study of Cardiovascular and Exercise Physiology in Patients With Previous Venous Thrombosis in the Inferior Vena Cava and Iliofemoral Veins.
- ClinicalTrials.gov ID
- NCT05296499
- Acronym / sponsor ID
- 254956
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 20 Oct 2022 (estimated)
- Study completion
- 20 Apr 2023 (estimated)
- First posted
- 25 Mar 2022 (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.
Deep vein thrombosis (DVT) can cause long-term scarring and narrowing of veins. When there is extensive damage to the veins in the legs, groin or abdomen it can affect the way that blood is able to flow back up to the heart. Some patients are left with severe symptoms such as pain, leg swelling and ulcers, and have surgical treatment with nitinol stents to re-open the veins and relieve symptoms. The primary aim of this study is to investigate venous blood flow to the heart during exercise in patients with extensive damage to the veins in the groin and abdomen after DVT, and changes that happen after stenting.
Detailed description
Participants will have cardiopulmonary exercise testing, 6 minute walk test and basic blood tests to establish exercise tolerance and rule out other heart and lung conditions. Exercise cardiac MRI will be used to evaluate cardiac function during exercise. All participants will complete generic and disease specific quality of life questionnaires.
Participants who are having a stenting procedure will repeat assessments 6-8 weeks after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea | – | Diagnostic Test: Cardiopulmonary exercise test (CPET), Diagnostic Test: Exercise cardiac MRI, Other: 6 minute walk test, Diagnostic Test: Blood tests, Other: Quality of life questionnaires, Other: Repeat baseline assessments, Diagnostic Test: MR venogramBaseline assessments Post-operative assessments if applicable |
| Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea | – | Diagnostic Test: Cardiopulmonary exercise test (CPET), Diagnostic Test: Exercise cardiac MRI, Other: 6 minute walk test, Diagnostic Test: Blood tests, Other: Quality of life questionnaires, Other: Repeat baseline assessments, Diagnostic Test: MR venogramBaseline assessments Post-operative assessments if applicable |
| Unilateral iliac venous outflow obstruction | – | Diagnostic Test: Cardiopulmonary exercise test (CPET), Diagnostic Test: Exercise cardiac MRI, Other: 6 minute walk test, Diagnostic Test: Blood tests, Other: Quality of life questionnaires, Other: Repeat baseline assessments, Diagnostic Test: MR venogramBaseline assessments Post-operative assessments if applicable |
| Age and sex matched controls | – | Diagnostic Test: Cardiopulmonary exercise test (CPET), Diagnostic Test: Exercise cardiac MRI, Other: 6 minute walk test, Other: Quality of life questionnaires, Other: Repeat baseline assessmentsBaseline assessments |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with previous deep vein thrombosis /chronic outflow obstruction in the iliofemoral veins and inferior vena cava.
Key inclusion criteria (15 listed)
- ->16 years of age
- Consent to participate in the research study and be willing to commit to study requirements, including completion of questionnaires and follow up visits.
- Venous thrombosis/obstruction involving the inferior vena cava >12 months ago.
- Symptoms of exertional dyspnoea reported by patient.
- Judged by the chief investigator as suitable for surgical intervention before recruitment to the study.
Key exclusion criteria (19 listed)
- DVT or PE in last 12 months
- Significant or untreated left sided heart disease (eg coronary artery disease, LV dysfunction, valvular abnormalities, congenital heart disease, chronic or paroxysmal arrhythmias)
- Significant or untreated chronic lung disease (eg asthma, COPD, ILD)
- Moderate to severe renal disease
- Moderate to severe liver disease
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 |
|---|---|---|
| Cardiopulmonary exercise test (CPET)Cardiopulmonary exercise testing using cycle ergonomenter | Diagnostic test | Age and sex matched controls, Unilateral iliac venous outflow obstruction, Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea, Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea |
| Exercise cardiac MRIExercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET | Diagnostic test | Age and sex matched controls, Unilateral iliac venous outflow obstruction, Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea, Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea |
| 6 minute walk test6MWT | Other | Age and sex matched controls, Unilateral iliac venous outflow obstruction, Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea, Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea |
| Blood testsFBC, U\&E, LFTS | Diagnostic test | Unilateral iliac venous outflow obstruction, Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea, Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea |
| Quality of life questionnairesSF36, EQ5D, VEINES-QoL/Sym | Other | Age and sex matched controls, Unilateral iliac venous outflow obstruction, Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea, Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea |
| Repeat baseline assessmentsrepeat baseline | Other | Age and sex matched controls, Unilateral iliac venous outflow obstruction, Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea, Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea |
| MR venogramMRI scan of venous system | Diagnostic test | Unilateral iliac venous outflow obstruction, Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea, Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea |
Primary outcome
VO2 max after stenting
Time frame: 6-8 weeks post surgery
As determined by cardiopulmonary exercise testing
Peak cardiac output during exercise
Time frame: 6-8 weeks post surgery
as determined by exercise cardiac MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis Deep (Limbs) and Post Thrombotic Syndrome, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 15 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 25 Mar 2022. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max after stenting (time frame: 6-8 weeks post surgery). The study lists 2 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 25 Mar 2022.