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Long Term Assessment of Post Thrombotic Syndrome : OPTIMEV Study ( SPOT )

CompletedN/A

Sponsor: Association des Médecins Vasculaires Hospitaliers

Conditions: Post Thrombotic Syndrome, Venous Thromboembolism, Cardiovascular Diseases

Interventions: Villalta phone score > or = to 5, Villalta phone score < 5

Countries: France

Post-thrombotic syndrome (PTS) is a frequent and burdensome complication of deep-vein thrombosis (DVT). In the absence of curative treatment of established PTS, its management is based on the prevention of its occurrence thanks to anticoagulants and compression stockings. So far, predictors of disabling PTS are unknown precluding from optimally selecting patients for invasive (early thrombus removal) or innovative/expensive treatments. In addition, little is known on the incidence of PTS in the very long-term. Objectives: To assess, 12 years after a symptomatic venous thromboembolic (VTE) event, Primary objective: incidence and severity of PTS after a lower limb DVT. Main Secondary objectives: 1. Incidence and severity of PTS according to VTE initial presentation (isolated distal DVT, isolated proximal DVT, PE + DVT). 2. Incidence and risk factors of disabling PTS Methods: Very long-term follow-up (12 years) of patients recruited in the large, multicentre, prospective, observational OPTIMEV study for a suspicion of VTE confirmed or ruled out with objective tests (Clinical Trials NCT00670540). All patients with a DVT, an isolated PE and a random selection of controls (VTE - patients without any history of VTE after the 3 years of follow-up) will first benefit from a phone-PTS assessment. Those patients presenting at least a mild venous insufficiency and a selection of controls will undergo a clinical follow-up visit with clinical and Compleat Ultra Sound (CUS) assessment of PTS/venous insufficiency and an assessment of quality of life. Perspectives: Improving our knowledge of PTS' incidence and predictors and of the impact of usual treatment. Better selecting patients eligible for invasive/innovative/expensive preventative procedures.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Exposed patients: Patients with a lower limb DVT and/or a PE
* Unexposed patients: Random selection of controls (1:1) free from any VTE event at the 3 years follow-up visit

Exclusion Criteria:

* Severe venous insufficiency at baseline (CEAP C5-C6)
* Severe lower limb peripheral arterial disease (critical limb ischemia)
* Altered mental status
* Decline to participate

Locations (1)

Grenoble, France