Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome: ETERecaVSPT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- VO2 max
Study Overview
Brief Summary
Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient eligible for endovascular treatment for post-thrombotic syndrome in a chronic context (6 months after the occurrence of thrombosis, without time limit), after validation of the indication during a monthly medical-radiological PCR (St Eloi vascular medicine team and vascular radiologist performing the endovascular treatment)
- •Age >= 18 years
Exclusion Criteria
- •Contraindication to the performance of a maximal effort test on a cyclo-ergometer
- •Refusal of consent after information
- •Adult protected by law (guardianship, curatorship)
- •Pregnant or breastfeeding woman
- •Patient not affiliated to a social security system or not benefiting from such a system
Arms & Interventions
Stress test
All patients will undergo a stress test before and after venous recanalization.
Intervention: Stress test (Diagnostic Test)
Outcomes
Primary Outcomes
VO2 max
Time Frame: From baseline and 8 weeks
Change in VO₂ max is the maximum (max) rate (V) of oxygen (O₂) the body is able to use during exercise from baseline to 8 weeks. It is measured in liters of O2 per minute
Secondary Outcomes
- Exercise change in Inspiratory capacity (in litres)(From baseline and 8 weeks)
- Maximal exercise O2 arterial pressure (PaO2, in mmHg)(From baseline and 8 weeks)
- Maximal isometric torque during leg extension (in Newton.meters)(From baseline and 8 weeks)
- Lower limb extracellular/total water (in %)(From baseline and 8 weeks)
- Maximum aerobic power (in Watts)(From baseline and 8 weeks)
- Maximal exercise cardiac output (in litres per minute)(From baseline and 8 weeks)
- Maximal exercise capillary volume (in millilitres)(From baseline and 8 weeks)
- Isowork power(From baseline and 8 weeks)