Epidemiology of Thromboembolism Disease: A Cohort Study

NCT ID: NCT00670540

Last Updated: 2012-05-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8256 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2010-02-28

Brief Summary

The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied

1. do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ?

2. Is it necessary to obtain a detailed history of thromboembolic disease ?

3. Do older patients have particular risk factors ?

4. Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ?

5. Do predictive clinical scores have the same performance for both in and outpatients ?

6. Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?

7. The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.

Detailed Description

The OPTIMEV study is a prospective epidemiological multicenter cohort study, including in-and outpatients clinically suspected of thromboembolic disease. Deep vein thrombosis is diagnosed using a duplex ultrasound examination, whereas pulmonary embolism is investigated by lung scan scintigraphy or computed helical tomodensitometry and/or duplex ultrasound examination. Initial data on medical history, clinical symptoms, presence of transient and chronic risk factors, diagnosis at the end of the medical examination, diagnostic tests results, treatment (type and duration) are collected by the physician into an electronic medical record. Other general medical considerations are collected (particularly on cardiovascular diseases). A phone follow up at 3 months, 1, 2 and 3 years is realised by the Centre for Clinical Research of Grenoble. All Venous ThromboEmbolism (VTE) positive patients (including superficial vein thrombosis) are contacted. For each VTE positive a negative one is selected (same site, same season). Data on mortality, development or recurrence of VTE, treatments prescribed (type + duration), major bleeding, cancer onset, cardiovascular events and venous insufficiency (leg ulcer) are collected. All these serious adverse events are documented and reviewed by an independent critical events committee.

Conditions

Vascular Diseases; Embolism and Thrombosis; Phlebitis; Venous Insufficiency; Pulmonary Embolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)

procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis

Intervention Type: OTHER

patients with a clinical suspicion of Venous ThromboEmbolism (VTE = Deep Vein Thrombosis or Pulmonary Embolism) were eligible

Interventions

procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis

patients with a clinical suspicion of Venous ThromboEmbolism (VTE = Deep Vein Thrombosis or Pulmonary Embolism) were eligible

Intervention Type: OTHER

Other Intervention Names

VTE (venous thromboembolism); DVT (deep vein thrombosis); PE (pulmonary embolism)

Eligibility Criteria

Inclusion Criteria

• patient aged more than 18
• male or female
• patients with clinical thromboembolic signs (deep vein thrombosis or pulmonary embolism)

Exclusion Criteria

• patient less than 18 years old
• patient unable to understand
• patient who refused to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

SFMV (Société Française de Médecine Vasculaire)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Luc JB BOSSON, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Marie Antoinette SEVESTRE, MD

Role: STUDY_CHAIR

Amiens University Hospital

Locations

University Hospital ND des Bruyeres Liege

Chênée, , Belgium

General Hospital

Abbeville, , France

Office-based Specialist in vascular medecine

Albertville, , France

Office-based Specialist in vascular medecine

Albi, , France

Office-based Specialist in vascular medecine

Alençon, , France

Office-based Specialist in vascular medecine

Alès, , France

Office-based Specialist in vascular medecine

Ambares, , France

Office-based Specialist in vascular medecine

Amberieu En Buget, , France

Office-based Specialist in vascular medecine

Amiens, , France

University Hospital

Amiens, , France

Office-based Specialist in vascular medecine

Ancenis, , France

Office-based Specialist in vascular medecine

Angers, , France

University Hospital

Angers, , France

Office-based Specialist in vascular medecine

Annecy, , France

Hospital

Annecy, , France

Hospital

Armentières, , France

Office-based Specialist in vascular medecine

Arnouville, , France

Office-based Specialist in vascular medecine

Arpajon, , France

Office-based Specialist in vascular medecine

Arras, , France

Office-based Specialist in vascular medecine

Aubenas, , France

Hospital

Auch, , France

Office-based Specialist in vascular medecine

Auxerre, , France

Office-based Specialist in vascular medecine

Bagnoles-de-l'orme, , France

Office-based Specialist in vascular medecine

Beauvais, , France

University Hospital

Belfort, , France

Office-based Specialist in vascular medecine

Bergerac, , France

Office-based Specialist in vascular medecine

Besançon, , France

Office-based Specialist in vascular medecine

Béziers, , France

Office-based Specialist in vascular medecine

Blagnac, , France

Office-based Specialist in vascular medecine

Bordeaux, , France

Hospital St ANDRE

Bordeaux, , France

Office-based Specialist in vascular medecine

Boulogne-sur-Mer, , France

Office-based Specialist in vascular medecine

Bourg-en-Bresse, , France

Office-based Specialist in vascular medecine

Bourgoin, , France

Office-based Specialist in vascular medecine

Brest, , France

University Hospital La Cavale Blanche

Brest, , France

Office-based Specialist in vascular medecine

Bretenoux, , France

Office-based Specialist in vascular medecine

Brétigny-sur-Orge, , France

Office-based Specialist in vascular medecine

Bron, , France

Office-based Specialist in vascular medecine

Cabestany, , France

University Hospital

Caen, , France

Office-based Specialist in vascular medecine

Caluire-et-Cuire, , France

Office-based Specialist in vascular medecine

Cambrai, , France

Office-based Specialist in vascular medecine

Cannes, , France

Office-based Specialist in vascular medecine

Carcassonne, , France

Hospital Antoine Gayraud

Carcassonne, , France

Office-based Specialist in vascular medecine

Castanet-Tolosan, , France

Office-based Specialist in vascular medecine

Castres, , France

Office-based Specialist in vascular medecine

Cenon, , France

Office-based Specialist in vascular medecine

Chalon En Champagne, , France

Office-based Specialist in vascular medecine

Chalon-sur-Saône, , France

Office-based Specialist in vascular medecine

Chambéry, , France

Hospital

Chambéry, , France

Office-based Specialist in vascular medecine

Champagnole, , France

Office-based Specialist in vascular medecine

Chantilly, , France

Office-based Specialist in vascular medecine

Charleville-Mézières, , France

Office-based Specialist in vascular medecine

Chartres, , France

Office-based Specialist in vascular medecine

Châteaubriant, , France

Office-based Specialist in vascular medecine

Cholet, , France

Office-based Specialist in vascular medecine

Clamart, , France

Office-based Specialist in vascular medecine

Clapiers, , France

Office-based Specialist in vascular medecine

Clermont-Ferrand, , France

Hospital Hotel Dieu

Clermont-Ferrand, , France

Office-based Specialist in vascular medecine

Clermont-l'Hérault, , France

Office-based Specialist in vascular medecine

Clisson, , France

Office-based Specialist in vascular medecine

Cluses, , France

Office-based Specialist in vascular medecine

Colomiers, , France

General Hospital

Compiègne, , France

Office-based Specialist in vascular medecine

Coulommiers, , France

Office-based Specialist in vascular medecine

Crolles, , France

Office-based Specialist in vascular medecine

Denain, , France

Office-based Specialist in vascular medecine

Dieppe, , France

Office-based Specialist in vascular medecine

Dijon, , France

Hospital Bocage

Dijon, , France

University Hospital

Dijon, , France

Office-based Specialist in vascular medecine

Draguignan, , France

Office-based Specialist in vascular medecine

Ermont, , France

Office-based Specialist in vascular medecine

Échirolles, , France

Office-based Specialist in vascular medecine

Évreux, , France

Office-based Specialist in vascular medecine

Feytiat, , France

Office-based Specialist in vascular medecine

Fécamp, , France

Office-based Specialist in vascular medecine

Figeac, , France

Hospital

Flers, , France

Office-based Specialist in vascular medecine

Foix, , France

Hospital Val d'Ariege

Foix, , France

Office-based Specialist in vascular medecine

Fontenay-le-Comte, , France

Office-based Specialist in vascular medecine

Glanes, , France

Office-based Specialist in vascular medecine

Grenoble, , France

University Hospital Grenoble

Grenoble, , France

Office-based Specialist in vascular medecine

Gruchet-le-Valasse, , France

Office-based Specialist in vascular medecine

Hœnheim, , France

Office-based Specialist in vascular medecine

Issy-les-Moulineaux, , France

Office-based Specialist in vascular medecine

Istres, , France

Office-based Specialist in vascular medecine

L'Île-Rousse, , France

Office-based Specialist in vascular medecine

La Roche-sur-Yon, , France

Departemental Hospital

La Roche-sur-Yon, , France

Office-based Specialist in vascular medecine

La Rochelle, , France

Office-based Specialist in vascular medecine

Lannion, , France

Office-based Specialist in vascular medecine

Lattes, , France

Office-based Specialist in vascular medecine

Laval, , France

Office-based Specialist in vascular medecine

Laxou, , France

Hospital Versailles

Le Chesnay, , France

Office-based Specialist in vascular medecine

Le Mans, , France

Office-based Specialist in vascular medecine

Le Quesnoy, , France

Office-based Specialist in vascular medecine

Levallois-Perret, , France

Office-based Specialist in vascular medecine

Limoges, , France

Office-based Specialist in vascular medecine

Lisieux, , France

Hospital Saint Philibert

Lomme, , France

Office-based Specialist in vascular medecine

Longjumeau, , France

Office-based Specialist in vascular medecine

Longwy, , France

Office-based Specialist in vascular medecine

Lons-le-Saunier, , France

Office-based Specialist in vascular medecine

Lorient, , France

Office-based Specialist in vascular medecine

Louviers, , France

Hospital Edouard Herriot

Lyon, , France

University Hospital

Lyon, , France

Office-based Specialist in vascular medecine

Malemort-sur-Corrèze, , France

Office-based Specialist in vascular medecine

Manosque, , France

Office-based Specialist in vascular medecine

Mantes-la-Jolie, , France

Office-based Specialist in vascular medecine

Marcq-en-Barœul, , France

Office-based Specialist in vascular medecine

Marseille, , France

Office-based Specialist in vascular medecine

Martinique, , France

Office-based Specialist in vascular medecine

Maurepas, , France

Office-based Specialist in vascular medecine

Meaux, , France

Office-based Specialist in vascular medecine

Metz, , France

Office-based Specialist in vascular medecine

Meudon, , France

Office-based Specialist in vascular medecine

Moissac, , France

Office-based Specialist in vascular medecine

Montaigu, , France

Office-based Specialist in vascular medecine

Montbéliard, , France

General Hospital

Montbéliard, , France

Hospital Jacques Monod

Montivilliers, , France

Office-based Specialist in vascular medecine

Montluçon, , France

Hospital

Montluçon, , France

Hospital

Montmorillon, , France

Office-based Specialist in vascular medecine

Montpellier, , France

Hospital St Eloi

Montpellier, , France

Office-based Specialist in vascular medecine

Mulhouse, , France

Office-based Specialist in vascular medecine

Nancy, , France

Office-based Specialist in vascular medecine

Nantes, , France

Office-based Specialist in vascular medecine

Narbonne, , France

Office-based Specialist in vascular medecine

Nice, , France

Office-based Specialist in vascular medecine

Niort, , France

Office-based Specialist in vascular medecine

Nîmes, , France

Office-based Specialist in vascular medecine

Noumea (Nouvelle Calédonie), , France

Office-based Specialist in vascular medecine

Noyal-Pontivy, , France

Office-based Specialist in vascular medecine

Noyon, , France

Office-based Specialist in vascular medecine

Orange, , France

Regional Hospital

Orleans La Source, , France

Office-based Specialist in vascular medecine

Orléans, , France

Office-based Specialist in vascular medecine

Paris, , France

Hospital Croix Saint Simon

Paris, , France

Office-based Specialist in vascular medecine

Pessac, , France

Hospital

Périgueux, , France

Office-based Specialist in vascular medecine

Péronne, , France

Office-based Specialist in vascular medecine

Poissy, , France

Office-based Specialist in vascular medecine

Poitiers, , France

Office-based Specialist in vascular medecine

Pontarlier, , France

Office-based Specialist in vascular medecine

Pornic, , France

Office-based Specialist in vascular medecine

Puilboreau, , France

Office-based Specialist in vascular medecine

Quimper, , France

Office-based Specialist in vascular medecine

Rambouillet, , France

Office-based Specialist in vascular medecine

Redon, , France

Office-based Specialist in vascular medecine

Reims, , France

University Hospital

Reims, , France

Office-based Specialist in vascular medecine

Riom, , France

Office-based Specialist in vascular medecine

Rivesaltes, , France

Office-based Specialist in vascular medecine

Rochefort, , France

Office-based Specialist in vascular medecine

Rodez, , France

Hospital

Rodez, , France

Office-based Specialist in vascular medecine

Romans-sur-Isère, , France

Office-based Specialist in vascular medecine

Rouen, , France

Office-based Specialist in vascular medecine

Sablé-sur-Sarthe, , France

Office-based Specialist in vascular medecine

Saint Genevieve Des Bois, , France

Cmc Les Petites Roches

Saint Hilaire Du Touvert, , France

Office-based Specialist in vascular medecine

Saint Pierre (ile de La Reunion), , France

Office-based Specialist in vascular medecine

Saint-Aubin-de-Médoc, , France

Office-based Specialist in vascular medecine

Saint-Benoît, , France

Office-based Specialist in vascular medecine

Saint-Brieuc, , France

Office-based Specialist in vascular medecine

Saint-Chamond, , France

Office-based Specialist in vascular medecine

Saint-Cloud, , France

Office-based Specialist in vascular medecine

Saint-Cyr-l'École, , France

Office-based Specialist in vascular medecine

Saint-Etienne, , France

University Hospital

Saint-Etienne, , France

Office-based Specialist in vascular medecine

Saint-Égrève, , France

Office-based Specialist in vascular medecine

Saint-Gaudens, , France

Office-based Specialist in vascular medecine

Saint-Germain-en-Laye, , France

Office-based Specialist in vascular medecine

Saint-Lô, , France

Memorial Hospital

Saint-Lô, , France

Office-based Specialist in vascular medecine

Saint-Martin-Boulogne, , France

Office-based Specialist in vascular medecine

Saint-Priest, , France

Hospital

Saint-Quentin, , France

Office-based Specialist in vascular medecine

Sallanches, , France

Office-based Specialist in vascular medecine

Salon-de-Provence, , France

Office-based Specialist in vascular medecine

Sarcelles, , France

Office-based Specialist in vascular medecine

Sarrebourg, , France

Office-based Specialist in vascular medecine

Sarreguemines, , France

Office-based Specialist in vascular medecine

Saverne, , France

Office-based Specialist in vascular medecine

Savigny-sur-Orge, , France

Office-based Specialist in vascular medecine

Sceaux, , France

Office-based Specialist in vascular medecine

Sèvres, , France

Office-based Specialist in vascular medecine

Sélestat, , France

Office-based Specialist in vascular medecine

Strasbourg, , France

Regional University Hospital

Strasbourg, , France

Office-based Specialist in vascular medecine

Talant, , France

Office-based Specialist in vascular medecine

Tarare, , France

Office-based Specialist in vascular medecine

Toulouse, , France

University Hospital Rangueil Larrey

Toulouse, , France

University Hospital Rangueil

Toulouse, , France

University Hospital

Toulouse, , France

Office-based Specialist in vascular medecine

Tours, , France

Office-based Specialist in vascular medecine

Trois Rivieres (guadeloupe), , France

Office-based Specialist in vascular medecine

Troyes, , France

Office-based Specialist in vascular medecine

Valence, , France

Office-based Specialist in vascular medecine

Vannes, , France

Office-based Specialist in vascular medecine

Vendôme, , France

Office-based Specialist in vascular medecine

Verrières-le-Buisson, , France

Office-based Specialist in vascular medecine

Versailles, , France

Office-based Specialist in vascular medecine

Vesoul, , France

Office-based Specialist in vascular medecine

Vénissieux, , France

Office-based Specialist in vascular medecine

Vichy, , France

Office-based Specialist in vascular medecine

Vienne, , France

Office-based Specialist in vascular medecine

Villebon-sur-Yvette, , France

Office-based Specialist in vascular medecine

Villefranche-sur-Saône, , France

Office-based Specialist in vascular medecine

Villemoisson-sur-Orge, , France

Office-based Specialist in vascular medecine

Villeurbanne, , France

Office-based Specialist in vascular medecine

Vincennes, , France

Office-based Specialist in vascular medecine

Viroflay, , France

Office-based Specialist in vascular medecine

Vizille, , France

Office-based Specialist in vascular medecine

Voiron, , France

Office-based Specialist in vascular medecine

Wissembourg, , France

Office-based Specialist in vascular medecine

Wizernes, , France

Office-based Specialist in vascular medecine

Basse-Terre, , Guadeloupe

Countries

Belgium; France; Guadeloupe

References

Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8. doi: 10.1001/archinte.163.21.2613.

Reference Type: BACKGROUND

PMID: 14638561 (View on PubMed)

Samama MM. An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: the Sirius study. Arch Intern Med. 2000 Dec 11-25;160(22):3415-20. doi: 10.1001/archinte.160.22.3415.

Reference Type: BACKGROUND

PMID: 11112234 (View on PubMed)

Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5.

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Stein PD, Hull RD, Ghali WA, Patel KC, Olson RE, Meyers FA, Kalra NK. Tracking the uptake of evidence: two decades of hospital practice trends for diagnosing deep vein thrombosis and pulmonary embolism. Arch Intern Med. 2003 May 26;163(10):1213-9. doi: 10.1001/archinte.163.10.1213.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 25104514 (View on PubMed)

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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 22429908 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20630688 (View on PubMed)

Other Identifiers

DCIC-04-02

Identifier Type: -

Identifier Source: org_study_id