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

Summary

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.

Conditions

• Post Thrombotic Syndrome
• Venous Thromboembolism
• Cardiovascular Diseases

Interventions

OTHER

Villalta phone score > or = to 5

Follow up call. At the end of the follow-up, the patients who received an Utne and Sandset Villalta phone score \> or = 5 will have a visit with clinical and CUS assessments of PTS/ venous insufficiency. All patients will have self administered-questionnaires. For Grenoble Center, the 200 first patients with clinical follow-up will have an Echo-Doppler examination.

OTHER

Villalta phone score < 5

Follow up call. At the end of the follow-up, the patients who received an Utne and Sandset Villalta phone score \< 5, will don't have a clinical follow up. All patients will have self administered-questionnaires.

Sponsors & Collaborators

• Daiichi Sankyo

  collaborator INDUSTRY

• Ministry of Health, France

  collaborator OTHER_GOV

• LEO Pharma

  collaborator INDUSTRY

• Sanofi

  collaborator INDUSTRY

• University Hospital, Grenoble

  collaborator OTHER

• Association des Médecins Vasculaires Hospitaliers

  lead OTHER

Principal Investigators

• Jean-Luc JB Bosson, MD, PhD · University Hospital, Grenoble

• Jean-Philippe JP Galanaud, MD, PhD · Montpellier University Hospital

• Gilles GP Pernod, MD, PhD · University Hospital, Grenoble

• Marie-Antoinette MS Sevestre, MD, PhD · Amiens University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-11

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• France

Study Locations