Pulmonary Embolism Clinical Trial
— OPTIMEVOfficial title:
A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism
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 |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | Ministry of Health, France, Sanofi, SFMV (Société Française de Médecine Vasculaire) |
Belgium, France, Guadeloupe,
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
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 |
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