Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome: ETERecaVSPT

Conditions
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Post Thrombotic Syndrome, Venous Thromboses, Claudication, Intermittent

Intervention / Treatment
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* Diagnostic Test: Stress test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress test<br>All patients will undergo a stress test before and after venous recanalization. | Diagnostic Test: Stress test<br>* Diagnostic Test: Maximum effort test (CPET) on a cycloergometer Leg muscle strength assessment Leg muscle mass, composition and water compartments (segmental bioelectrical impedance) Spirometry, arterial blood gaz, NO/CO transfer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 max | 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 | From baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum aerobic power (in Watts) | Maximum aerobic power is measured in watts before and after venous recanalization | From baseline and 8 weeks | 
| Isowork power | The isowork power is the power output assessed at the V'O2max before recanalization | From baseline and 8 weeks | 
| Maximal exercise cardiac output (in litres per minute) | Maximal exercise cardiac output is the cardiac output assessed by thoracic impedance et peak exercise before and after venous recanalization | From baseline and 8 weeks | 
| Exercise change in Inspiratory capacity (in litres) | Exercise change in Inspiratory capacity is the change between rest and peak exercise of the inspiratory capacity (the volume between end-expiratory volume and total lung capacity) before and after venous recanalization | From baseline and 8 weeks | 
| Maximal exercise capillary volume (in millilitres) | Maximal exercise capillary volume is the capillary volume at peak exercise assessed by NO/CO transfer before and after venous recanalization | From baseline and 8 weeks | 
| Maximal exercise O2 arterial pressure (PaO2, in mmHg) | Maximal exercise O2 arterial pressure is the oxygen partial pressure in the arterial blood, assessed at peak exercise, before and after venous recanalization | From baseline and 8 weeks | 
| Maximal isometric torque during leg extension (in Newton.meters) | Maximal isometric strength during leg extension is the maximal torque of the leg extension at 90° knee flexion assessed by a torque sensor before and after venous recanalization | From baseline and 8 weeks | 
| Lower limb extracellular/total water (in %) | Lower limb extracellular/total water is the water volume int the body compartments in each lower limb, assessed by a segmental bioelectrical impedancemeter before and after venous recanalization | From baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iliac vein, inferior vena cava, exercice tolerance, cardio-pulmonary exercice testing, muscle physiological testing