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

NCT03054727 | Completed DMC

• 1 other identifier: OPTIMEV SPOT
• Study Type: observational
• Target: 2,475
• Locations: 1 country
• Sites: 1

Brief 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. 1.Incidence and severity of PTS according to VTE initial presentation (isolated distal DVT, isolated proximal DVT, PE + DVT).
2. 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).

Conditions

Post Thrombotic Syndrome; Venous Thromboembolism; Cardiovascular Diseases

Keywords

Post Thrombotic Syndrome; Venous Thromboembolism; Incidence; Risk factors; Venous ulcer

Outcome Measures

Primary Outcomes (1)

• disabling PTS

  Clinical Villalta score \> or = 10 (moderate or severe PTS) and/or venous claudication (Villalta score assessed during the clinical Follow-Up visit by a vascular medicine physician (signs) and by the patient (symptoms)

  12 years

Secondary Outcomes (12)

• Risk factors of disabling PTS

  at inclusion

• PTS severity

  at inclusion

• Incidence of venous insufficiency

  at inclusion

• Global Quality of life

  at inclusion

• Specific Quality of life

  at inclusion

Study Arms (2)

Villalta phone score > or = to 5

patients with VTE in the OPTIMEV cohort with an Utne and Sandset Villalta phone score \> or = to 5 at the end of the follow-up call AND a random selection of patients free from any VTE after the first 3 years of follow-up in OPTIMEV with an Utne and Sandset Villalta phone score \> or = to 5 at the end of the follow-up call

Other: Villalta phone score > or = to 5; Other: Villalta phone score < 5

Villalta phone score < 5

patients with VTE in the OPTIMEV cohort with an Utne and Sandset Villalta phone score \< 5 at the end of the follow-up call AND random selection of patients free from any VTE after the first 3 years of follow-up in OPTIMEV with an Utne and Sandset Villalta phone score \< 5 at the end of the follow-up call

Other: Villalta phone score > or = to 5; Other: Villalta phone score < 5

Interventions

Villalta phone score > or = to 5 OTHER

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.

Also known as: Clinical Follow-Up Group

Villalta phone score < 5; Villalta phone score > or = to 5

Villalta phone score < 5 OTHER

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.

Also known as: No Clinical Follow-Up Group

Villalta phone score < 5; Villalta phone score > or = to 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

study of exposed and unexposed patients nested in the propsective OPTIMEV cohort

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Association des Médecins Vasculaires Hospitaliers: lead
• Daiichi Sankyo: collaborator
• Ministry of Health, France: collaborator
• LEO Pharma: collaborator
• Sanofi: collaborator
• University Hospital, Grenoble: collaborator

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (17)

• Galanaud JP, Sevestre MA, Genty C, Pernod G, Quere I, Bosson JL. Is it useful to also image the asymptomatic leg in patients with suspected deep vein thrombosis?: comment. J Thromb Haemost. 2015 Nov;13(11):2127-30. doi: 10.1111/jth.13123. Epub 2015 Sep 30. No abstract available.

  PMID: 26332772 BACKGROUND

• Galanaud JP, Arnoult AC, Sevestre MA, Genty C, Bonaldi M, Guyard A, Giordana P, Pichot O, Colonna M, Quere I, Bosson JL; OPTIMEV-SFMV Investigators. Impact of anatomical location of lower limb venous thrombus on the risk of subsequent cancer. Thromb Haemost. 2014 Dec;112(6):1129-36. doi: 10.1160/TH14-04-0351. Epub 2014 Aug 7.

  PMID: 25104514 BACKGROUND

• Le Moigne E, Genty C, Meunier J, Arnoult AC, Righini M, Bressollette L, Bosson JL, Le Gal G; OPTIMEV Investigators. Validation of the LEFt score, a newly proposed diagnostic tool for deep vein thrombosis in pregnant women. Thromb Res. 2014 Sep;134(3):664-7. doi: 10.1016/j.thromres.2014.07.009. Epub 2014 Jul 17.

  PMID: 25087889 BACKGROUND

• Galanaud JP, Sevestre MA, Genty C, Kahn SR, Pernod G, Rolland C, Diard A, Dupas S, Jurus C, Diamand JM, Quere I, Bosson JL; OPTIMEV-SFMV investigators. Incidence and predictors of venous thromboembolism recurrence after a first isolated distal deep vein thrombosis. J Thromb Haemost. 2014 Apr;12(4):436-43. doi: 10.1111/jth.12512.

  PMID: 24450376 BACKGROUND

• Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.

  PMID: 22429908 BACKGROUND

• Maufus M, Bosson JL, Genty C, Delluc A, Imbert P, Gagne P, Rolland C, Bressollette L, Le Gal G. [Validation of a deep vein thrombosis prediction rule in primary care]. J Mal Vasc. 2012 Feb;37(1):9-14. doi: 10.1016/j.jmv.2011.10.005. Epub 2011 Dec 12. French.

  PMID: 22169238 BACKGROUND

• Galanaud JP, Genty C, Sevestre MA, Brisot D, Lausecker M, Gillet JL, Rolland C, Righini M, Leftheriotis G, Bosson JL, Quere I; OPTIMEV SFMV investigators. Predictive factors for concurrent deep-vein thrombosis and symptomatic venous thromboembolic recurrence in case of superficial venous thrombosis. The OPTIMEV study. Thromb Haemost. 2011 Jan;105(1):31-9. doi: 10.1160/TH10-06-0406. Epub 2010 Sep 30.

  PMID: 20886192 BACKGROUND

• Utne KK, Ghanima W, Foyn S, Kahn S, Sandset PM, Wik HS. Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome. Thromb Haemost. 2016 Jan;115(2):361-367. doi: 10.1160/th15-04-0318. Epub 2015 Sep 17.

  PMID: 26422814 BACKGROUND

• Johnson SA, Stevens SM, Woller SC, Lake E, Donadini M, Cheng J, Labarere J, Douketis JD. Risk of deep vein thrombosis following a single negative whole-leg compression ultrasound: a systematic review and meta-analysis. JAMA. 2010 Feb 3;303(5):438-45. doi: 10.1001/jama.2010.43.

  PMID: 20124539 BACKGROUND

• Galanaud JP, Sevestre MA, Genty C, Laroche JP, Zizka V, Quere I, Bosson JL; OPTIMEV SFMV investigators. Comparison of the clinical history of symptomatic isolated muscular calf vein thrombosis versus deep calf vein thrombosis. J Vasc Surg. 2010 Oct;52(4):932-8, 938.e1-2. doi: 10.1016/j.jvs.2010.05.019. Epub 2010 Jul 13.

  PMID: 20630688 BACKGROUND

• Sevestre MA, Quashie C, Genty C, Rolland C, Quere I, Bosson JL; Optimev study investigators. Clinical presentation and mortality in pulmonary embolism: the Optimev study. J Mal Vasc. 2010 Jul;35(4):242-9. doi: 10.1016/j.jmv.2010.05.004. Epub 2010 Jul 2.

  PMID: 20598461 BACKGROUND

• Sevestre MA, Labarere J, Casez P, Bressollette L, Haddouche M, Pernod G, Quere I, Bosson JL. Outcomes for inpatients with normal findings on whole-leg ultrasonography: a prospective study. Am J Med. 2010 Feb;123(2):158-65. doi: 10.1016/j.amjmed.2009.05.034.

  PMID: 20103025 BACKGROUND

• Casez P, Labarere J, Sevestre MA, Haddouche M, Courtois X, Mercier S, Lewandowski E, Fauconnier J, Francois P, Bosson JL. ICD-10 hospital discharge diagnosis codes were sensitive for identifying pulmonary embolism but not deep vein thrombosis. J Clin Epidemiol. 2010 Jul;63(7):790-7. doi: 10.1016/j.jclinepi.2009.09.002. Epub 2009 Dec 2.

  PMID: 19959332 BACKGROUND

• Galanaud JP, Sevestre-Pietri MA, Bosson JL, Laroche JP, Righini M, Brisot D, Boge G, van Kien AK, Gattolliat O, Bettarel-Binon C, Gris JC, Genty C, Quere I; OPTIMEV-SFMV Investigators. Comparative study on risk factors and early outcome of symptomatic distal versus proximal deep vein thrombosis: results from the OPTIMEV study. Thromb Haemost. 2009 Sep;102(3):493-500. doi: 10.1160/TH09-01-0053.

  PMID: 19718469 BACKGROUND

• Sevestre MA, Labarere J, Casez P, Bressollette L, Taiar M, Pernod G, Quere I, Bosson JL. Accuracy of complete compression ultrasound in ruling out suspected deep venous thrombosis in the ambulatory setting. A prospective cohort study. Thromb Haemost. 2009 Jul;102(1):166-72. doi: 10.1160/TH09-01-0048.

  PMID: 19572082 BACKGROUND

• Constans J, Salmi LR, Sevestre-Pietri MA, Perusat S, Nguon M, Degeilh M, Labarere J, Gattolliat O, Boulon C, Laroche JP, Le Roux P, Pichot O, Quere I, Conri C, Bosson JL. A clinical prediction score for upper extremity deep venous thrombosis. Thromb Haemost. 2008 Jan;99(1):202-7. doi: 10.1160/TH07-08-0485.

  PMID: 18217155 BACKGROUND

• Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quere I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study]. J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. doi: 10.1016/s0398-0499(05)88206-x. French.

  PMID: 16292199 BACKGROUND

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thromboembolism; Cardiovascular Diseases; Varicose Ulcer

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Venous Insufficiency; Thromboembolism; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean-Luc JB Bosson, MD, PhD

  University Hospital, Grenoble

  STUDY CHAIR

• Jean-Philippe JP Galanaud, MD, PhD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

• Gilles GP Pernod, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• Marie-Antoinette MS Sevestre, MD, PhD

  Amiens University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: February 16, 2017
• Study Start: July 11, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)