Post Thrombotic Syndrome, Venous Thromboses, Claudication, Intermittent
Conditions
Keywords
iliac vein, inferior vena cava, exercice tolerance, cardio-pulmonary exercice testing, muscle physiological testing
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.
Interventions
DIAGNOSTIC_TESTStress test
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
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2 max | 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
| Measure | Time frame | Description |
|---|---|---|
| Isowork power | From baseline and 8 weeks | The isowork power is the power output assessed at the V'O2max before recanalization |
| Maximal exercise cardiac output (in litres per minute) | From baseline and 8 weeks | Maximal exercise cardiac output is the cardiac output assessed by thoracic impedance et peak exercise before and after venous recanalization |
| Exercise change in Inspiratory capacity (in litres) | From baseline and 8 weeks | 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 |
| Maximum aerobic power (in Watts) | From baseline and 8 weeks | Maximum aerobic power is measured in watts before and after venous recanalization |
| Maximal exercise O2 arterial pressure (PaO2, in mmHg) | From baseline and 8 weeks | Maximal exercise O2 arterial pressure is the oxygen partial pressure in the arterial blood, assessed at peak exercise, before and after venous recanalization |
| Maximal isometric torque during leg extension (in Newton.meters) | From baseline and 8 weeks | 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 |
| Lower limb extracellular/total water (in %) | From baseline and 8 weeks | 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 |
| Maximal exercise capillary volume (in millilitres) | From baseline and 8 weeks | Maximal exercise capillary volume is the capillary volume at peak exercise assessed by NO/CO transfer before and after venous recanalization |
Countries
France
Outcome results
None listed