Epidemiology of Thromboembolism Disease: A Cohort Study

Pulmonary Embolism Clinical Trial

— OPTIMEV  

Official title:

A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670540
• Other study ID #: DCIC-04-02
• Status: Completed
• Phase: N/A
• First received: April 30, 2008
• Last updated: May 4, 2012
• Start date: November 2004
• Est. completion date: February 2010

Study information

• Verified date: May 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8256
• Est. completion date: February 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• 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

Locations

Country	Name	City	State
Belgium	University Hospital ND des Bruyeres Liege	Chenee
France	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	Alencon
France	Office-based Specialist in vascular medecine	Ales
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	Hospital	Annecy
France	Office-based Specialist in vascular medecine	Annecy
France	Hospital	Armentieres
France	Office-based Specialist in vascular medecine	Arnouville-les-Gonesse
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	Besancon
France	Office-based Specialist in vascular medecine	Beziers
France	Office-based Specialist in vascular medecine	Blagnac
France	Hospital St ANDRE	Bordeaux
France	Office-based Specialist in vascular medecine	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 Jallieu
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	Bretigny 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	Hospital Antoine Gayraud	Carcassonne
France	Office-based Specialist in vascular medecine	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 Saone
France	Hospital	Chambery
France	Office-based Specialist in vascular medecine	Chambery
France	Office-based Specialist in vascular medecine	Champagnole
France	Office-based Specialist in vascular medecine	Chantilly
France	Office-based Specialist in vascular medecine	Charleville Mezieres
France	Office-based Specialist in vascular medecine	Chartres
France	Office-based Specialist in vascular medecine	Chateaubriant
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	Hospital Hotel Dieu	Clermont Ferrand
France	Office-based Specialist in vascular medecine	Clermont Ferrand
France	Office-based Specialist in vascular medecine	Clermont L'Herault
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	Compiegne
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	Hospital Bocage	Dijon
France	Office-based Specialist in vascular medecine	Dijon
France	University Hospital	Dijon
France	Office-based Specialist in vascular medecine	Draguignan
France	Office-based Specialist in vascular medecine	Echirolles
France	Office-based Specialist in vascular medecine	Ermont
France	Office-based Specialist in vascular medecine	Evreux
France	Office-based Specialist in vascular medecine	Fecamp
France	Office-based Specialist in vascular medecine	Feytiat
France	Office-based Specialist in vascular medecine	Figeac
France	Hospital	Flers
France	Hospital Val d'Ariege	Foix
France	Office-based Specialist in vascular medecine	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	Hoenheim
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'ile Rousse
France	Departemental Hospital	La Roche Sur Yon
France	Office-based Specialist in vascular medecine	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
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 Correze
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 Baroeul
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	General Hospital	Montbeliard
France	Office-based Specialist in vascular medecine	Montbeliard
France	Hospital Jacques Monod	Montivilliers
France	Hospital	Montlucon
France	Office-based Specialist in vascular medecine	Montlucon
France	Hospital	Montmorillon
France	Hospital St Eloi	Montpellier
France	Office-based Specialist in vascular medecine	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	Nimes
France	Office-based Specialist in vascular medecine	Niort
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	Office-based Specialist in vascular medecine	Orleans
France	Regional Hospital	Orleans La Source
France	Hospital Croix Saint Simon	Paris
France	Office-based Specialist in vascular medecine	Paris
France	Hospital	Perigueux
France	Office-based Specialist in vascular medecine	Peronne
France	Office-based Specialist in vascular medecine	Pessac
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	Hospital	Rodez
France	Office-based Specialist in vascular medecine	Rodez
France	Office-based Specialist in vascular medecine	Romans Sur Isere
France	Office-based Specialist in vascular medecine	Rouen
France	Office-based Specialist in vascular medecine	Sable Sur Sarthe
France	Office-based Specialist in vascular medecine	Saint Aubin de Medoc
France	Office-based Specialist in vascular medecine	Saint Benoit
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'ecole
France	Office-based Specialist in vascular medecine	Saint Egreve
France	Office-based Specialist in vascular medecine	Saint Etienne
France	University Hospital	Saint Etienne
France	Office-based Specialist in vascular medecine	Saint Gaudens
France	Office-based Specialist in vascular medecine	Saint Genevieve Des Bois
France	Office-based Specialist in vascular medecine	Saint Germain En Laye
France	Cmc Les Petites Roches	Saint Hilaire Du Touvert
France	Memorial Hospital	Saint Lo
France	Office-based Specialist in vascular medecine	Saint Lo
France	Office-based Specialist in vascular medecine	Saint Martin Boulogne
France	Office-based Specialist in vascular medecine	Saint Pierre (ile de La Reunion)
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	Selestat
France	Office-based Specialist in vascular medecine	Sevres
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	Toulouse
France	University Hospital Rangueil	Toulouse
France	University Hospital Rangueil Larrey	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	Vendome
France	Office-based Specialist in vascular medecine	Venissieux
France	Office-based Specialist in vascular medecine	Verrieres 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	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 Saone
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
Guadeloupe	Office-based Specialist in vascular medecine	Basse Terre

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Ministry of Health, France, Sanofi, SFMV (Société Française de Médecine Vasculaire)

Countries where clinical trial is conducted

Belgium,  France,  Guadeloupe, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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, Quéré 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. French. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)	new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.	at 3 years	Yes
Secondary	Percentage of Participants Who Developed Major Bleeding Events		at 3 years	Yes
Secondary	Percentage of Participants With Treatment Anticoagulant Prescribed		after inclusion	Yes
Secondary	Percentage of Participants Who Developed Cardiovascular Events		at 3 years	Yes
Secondary	Percentage of Participants Who Died From Any Cause		at 3 years	Yes
Secondary	Percentage of Participants Who Developed Cancer Onset		at 3 years	Yes
Secondary	Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)		at 3 years	Yes

External Links

•   please click on the link OPTIMEV to see the site created for communication about the study during recruitment and afterwards