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| Name | Class |
|---|---|
| King's College London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea | Baseline assessments Post-operative assessments if applicable |
| |
| Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea | Baseline assessments Post-operative assessments if applicable |
| |
| Unilateral iliac venous outflow obstruction | Baseline assessments Post-operative assessments if applicable |
| |
| Age and sex matched controls | Baseline assessments |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiopulmonary exercise test (CPET) | Diagnostic Test | Cardiopulmonary exercise testing using cycle ergonomenter |
|
| Measure | Description | Time Frame |
|---|---|---|
| VO2 max after stenting | As determined by cardiopulmonary exercise testing | 6-8 weeks post surgery |
| Peak cardiac output during exercise | as determined by exercise cardiac MRI | 6-8 weeks post surgery |
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Inclusion Criteria:
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:
Group 2:
Group 3:
Exclusion Criteria:
All groups:
Group 4:
All of the above, plus:
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Participants with previous deep vein thrombosis /chronic outflow obstruction in the iliofemoral veins and inferior vena cava.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys and St Thomas' NHS Foundation Trust | Recruiting | London | SE1 7EH | United Kingdom |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054070 | Postthrombotic Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Exercise cardiac MRI | Diagnostic Test | Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET |
|
| 6 minute walk test | Other | 6MWT |
|
| Blood tests | Diagnostic Test | FBC, U&E, LFTS |
|
| Quality of life questionnaires | Other | SF36, EQ5D, VEINES-QoL/Sym |
|
| Repeat baseline assessments | Other | repeat baseline |
|
| MR venogram | Diagnostic Test | MRI scan of venous system |
|
| D014689 |
| Venous Insufficiency |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
| D019411 | Clinical Laboratory Techniques |