Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
56 participants
OBSERVATIONAL
2019-09-20
2023-04-20
Brief Summary
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Detailed Description
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Participants who are having a stenting procedure will repeat assessments 6-8 weeks after surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea
Baseline assessments Post-operative assessments if applicable
Cardiopulmonary exercise test (CPET)
Cardiopulmonary exercise testing using cycle ergonomenter
Exercise cardiac MRI
Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET
6 minute walk test
6MWT
Blood tests
FBC, U\&E, LFTS
Quality of life questionnaires
SF36, EQ5D, VEINES-QoL/Sym
Repeat baseline assessments
repeat baseline
MR venogram
MRI scan of venous system
Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea
Baseline assessments Post-operative assessments if applicable
Cardiopulmonary exercise test (CPET)
Cardiopulmonary exercise testing using cycle ergonomenter
Exercise cardiac MRI
Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET
6 minute walk test
6MWT
Blood tests
FBC, U\&E, LFTS
Quality of life questionnaires
SF36, EQ5D, VEINES-QoL/Sym
Repeat baseline assessments
repeat baseline
MR venogram
MRI scan of venous system
Unilateral iliac venous outflow obstruction
Baseline assessments Post-operative assessments if applicable
Cardiopulmonary exercise test (CPET)
Cardiopulmonary exercise testing using cycle ergonomenter
Exercise cardiac MRI
Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET
6 minute walk test
6MWT
Blood tests
FBC, U\&E, LFTS
Quality of life questionnaires
SF36, EQ5D, VEINES-QoL/Sym
Repeat baseline assessments
repeat baseline
MR venogram
MRI scan of venous system
Age and sex matched controls
Baseline assessments
Cardiopulmonary exercise test (CPET)
Cardiopulmonary exercise testing using cycle ergonomenter
Exercise cardiac MRI
Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET
6 minute walk test
6MWT
Quality of life questionnaires
SF36, EQ5D, VEINES-QoL/Sym
Repeat baseline assessments
repeat baseline
Interventions
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Cardiopulmonary exercise test (CPET)
Cardiopulmonary exercise testing using cycle ergonomenter
Exercise cardiac MRI
Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET
6 minute walk test
6MWT
Blood tests
FBC, U\&E, LFTS
Quality of life questionnaires
SF36, EQ5D, VEINES-QoL/Sym
Repeat baseline assessments
repeat baseline
MR venogram
MRI scan of venous system
Eligibility Criteria
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Inclusion Criteria
-\>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.
* 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.
Exclusion Criteria
* 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
* 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.
16 Years
ALL
Yes
Sponsors
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King's College London
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Guys and St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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Facility Contacts
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Other Identifiers
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254956
Identifier Type: -
Identifier Source: org_study_id
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