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| Sponsor: | University Hospital, Grenoble |
|---|---|
| Collaborators: |
Sanofi-Aventis Ministry of Health, France SFMV (Société Française de Médecine Vasculaire) |
| Information provided by: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT00670540 |
Purpose
The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied
| Condition | Intervention |
|---|---|
|
Vascular Diseases Embolism and Thrombosis Phlebitis Venous Insufficiency Pulmonary Embolism |
Other: procedure of DVT and PE diagnosis |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism |
| Enrollment: | 8256 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
patients with suspected VTE or PE
|
Other: procedure of DVT and PE diagnosis
patients with a clinical suspicion of VTE (deep vein thrombosis or pulmonary embolism) were eligible
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All male or female inpatients and outpatients hospital and office-based. 18 years old with clinical suspicion of deep vein thrombosis or pulmonary embolism.
Patients with cognitive disorders or language impairment preventing collection of risk factor data by history-taking were excluded.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Belgium | |
| University Hospital ND des Bruyeres Liege | |
| CHENEE, Belgium | |
| France | |
| University Hospital Grenoble | |
| GRENOBLE, France, 38043 | |
| Office-based Specialist in vascular medecine | |
| Albertville, France, 73200 | |
| Office-based Specialist in vascular medecine | |
| ALBI, France, 81000 | |
| Office-based Specialist in vascular medecine | |
| ALENCON, France, 61000 | |
| Office-based Specialist in vascular medecine | |
| ALES, France, 30100 | |
| Office-based Specialist in vascular medecine | |
| AMBARES, France, 33440 | |
| Office-based Specialist in vascular medecine | |
| AMBERIEU EN BUGET, France, 01500 | |
| Office-based Specialist in vascular medecine | |
| AMIENS, France, 80000 | |
| Office-based Specialist in vascular medecine | |
| ANCENIS, France, 44150 | |
| Office-based Specialist in vascular medecine | |
| ANGERS, France, 49000 | |
| Office-based Specialist in vascular medecine | |
| ANNECY, France, 74000 | |
| Office-based Specialist in vascular medecine | |
| Arnouville-les-Gonesse, France, 95400 | |
| Office-based Specialist in vascular medecine | |
| ARPAJON, France, 91290 | |
| Office-based Specialist in vascular medecine | |
| ARRAS, France, 62000 | |
| Office-based Specialist in vascular medecine | |
| AUBENAS, France, 07200 | |
| Office-based Specialist in vascular medecine | |
| AUXERRE, France, 89000 | |
| Office-based Specialist in vascular medecine | |
| BAGNOLES-DE-L'ORME, France, 61140 | |
| Office-based Specialist in vascular medecine | |
| BEAUVAIS, France, 60000 | |
| Office-based Specialist in vascular medecine | |
| BERGERAC, France, 24100 | |
| Office-based Specialist in vascular medecine | |
| BESANCON, France, 25000 | |
| Office-based Specialist in vascular medecine | |
| BEZIERS, France, 35500 | |
| Office-based Specialist in vascular medecine | |
| BLAGNAC, France, 31700 | |
| Office-based Specialist in vascular medecine | |
| BORDEAUX, France, 33000 | |
| Office-based Specialist in vascular medecine | |
| BOULOGNE SUR MER, France, 62200 | |
| Office-based Specialist in vascular medecine | |
| BOURG EN BRESSE, France, 01000 | |
| Office-based Specialist in vascular medecine | |
| BOURGOIN JALLIEU, France, 38300 | |
| Office-based Specialist in vascular medecine | |
| BREST, France, 29200 | |
| Office-based Specialist in vascular medecine | |
| BRETENOUX, France, 46130 | |
| Office-based Specialist in vascular medecine | |
| BRETIGNY SUR ORGE, France, 91220 | |
| Office-based Specialist in vascular medecine | |
| BRON, France, 69500 | |
| Office-based Specialist in vascular medecine | |
| CABESTANY, France, 66330 | |
| Office-based Specialist in vascular medecine | |
| CALUIRE ET CUIRE, France, 69300 | |
| Office-based Specialist in vascular medecine | |
| CAMBRAI, France, 59400 | |
| Office-based Specialist in vascular medecine | |
| CANNES, France, 06400 | |
| Office-based Specialist in vascular medecine | |
| CARCASSONNE, France, 11000 | |
| Office-based Specialist in vascular medecine | |
| CASTANET TOLOSAN, France, 31320 | |
| Office-based Specialist in vascular medecine | |
| CASTRES, France, 81100 | |
| Office-based Specialist in vascular medecine | |
| CENON, France, 33150 | |
| Office-based Specialist in vascular medecine | |
| CHALON SUR SAONE, France, 71100 | |
| Office-based Specialist in vascular medecine | |
| Chalon En Champagne, France, 51000 | |
| Office-based Specialist in vascular medecine | |
| CHAMBERY, France, 73000 | |
| Office-based Specialist in vascular medecine | |
| CHAMPAGNOLE, France, 39300 | |
| Office-based Specialist in vascular medecine | |
| CHANTILLY, France, 60500 | |
| Office-based Specialist in vascular medecine | |
| CHARLEVILLE MEZIERES, France, 08000 | |
| Office-based Specialist in vascular medecine | |
| CHARTRES, France, 28000 | |
| Office-based Specialist in vascular medecine | |
| CHATEAUBRIANT, France, 44110 | |
| Office-based Specialist in vascular medecine | |
| CHOLET, France, 49300 | |
| Office-based Specialist in vascular medecine | |
| CLAMART, France, 92140 | |
| Office-based Specialist in vascular medecine | |
| CLAPIERS, France, 34830 | |
| Office-based Specialist in vascular medecine | |
| CLERMONT FERRAND, France, 63000 | |
| Office-based Specialist in vascular medecine | |
| Clermont L'Herault, France, 34800 | |
| Office-based Specialist in vascular medecine | |
| CLISSON, France, 44190 | |
| Office-based Specialist in vascular medecine | |
| CLUSES, France, 74300 | |
| Office-based Specialist in vascular medecine | |
| COLOMIERS, France, 31770 | |
| Office-based Specialist in vascular medecine | |
| COULOMMIERS, France, 77120 | |
| Office-based Specialist in vascular medecine | |
| CROLLES, France, 38920 | |
| Office-based Specialist in vascular medecine | |
| NOUMEA (Nouvelle Calédonie), France, 98800 | |
| Office-based Specialist in vascular medecine | |
| DIEPPE, France, 76200 | |
| Office-based Specialist in vascular medecine | |
| DIJON, France, 21000 | |
| Office-based Specialist in vascular medecine | |
| DRAGUIGNAN, France, 83300 | |
| Office-based Specialist in vascular medecine | |
| ECHIROLLES, France, 38130 | |
| Office-based Specialist in vascular medecine | |
| ERMONT, France, 95120 | |
| Office-based Specialist in vascular medecine | |
| EVREUX, France, 27000 | |
| Office-based Specialist in vascular medecine | |
| FECAMP, France, 76400 | |
| Office-based Specialist in vascular medecine | |
| FEYTIAT, France, 87220 | |
| Office-based Specialist in vascular medecine | |
| FIGEAC, France, 46100 | |
| Office-based Specialist in vascular medecine | |
| FOIX, France, 09000 | |
| Office-based Specialist in vascular medecine | |
| FONTENAY LE COMTE, France, 85200 | |
| Office-based Specialist in vascular medecine | |
| MARTINIQUE, France, 97000 | |
| Office-based Specialist in vascular medecine | |
| GLANES, France, 46130 | |
| Office-based Specialist in vascular medecine | |
| GRENOBLE, France, 38000 | |
| Office-based Specialist in vascular medecine | |
| GRUCHET LE VALASSE, France, 76210 | |
| Office-based Specialist in vascular medecine | |
| HOENHEIM, France, 67800 | |
| Office-based Specialist in vascular medecine | |
| ISSY LES MOULINEAUX, France, 92130 | |
| Office-based Specialist in vascular medecine | |
| ISTRES, France, 13800 | |
| Office-based Specialist in vascular medecine | |
| LA ROCHE SUR YON, France, 85000 | |
| Office-based Specialist in vascular medecine | |
| LA ROCHELLE, France, 17000 | |
| Office-based Specialist in vascular medecine | |
| LANNION, France, 22300 | |
| Office-based Specialist in vascular medecine | |
| LATTES, France, 34970 | |
| Office-based Specialist in vascular medecine | |
| LAVAL, France, 53000 | |
| Office-based Specialist in vascular medecine | |
| LAXOU, France, 54520 | |
| Office-based Specialist in vascular medecine | |
| LE MANS, France, 72000 | |
| Office-based Specialist in vascular medecine | |
| LE QUESNOY, France, 59530 | |
| Office-based Specialist in vascular medecine | |
| LEVALLOIS, France, 92300 | |
| Office-based Specialist in vascular medecine | |
| L'ILE ROUSSE, France, 20220 | |
| Office-based Specialist in vascular medecine | |
| LIMOGES, France, 87000 | |
| Office-based Specialist in vascular medecine | |
| LISIEUX, France, 14100 | |
| Office-based Specialist in vascular medecine | |
| LONGJUMEAU, France, 91160 | |
| Office-based Specialist in vascular medecine | |
| LONGWY, France, 54440 | |
| Office-based Specialist in vascular medecine | |
| LONS LE SAUNIER, France, 39000 | |
| Office-based Specialist in vascular medecine | |
| LORIENT, France, 56100 | |
| Office-based Specialist in vascular medecine | |
| LOUVIERS, France, 27400 | |
| Office-based Specialist in vascular medecine | |
| MALEMORT SUR CORREZE, France, 19360 | |
| Office-based Specialist in vascular medecine | |
| MANOSQUE, France, 04100 | |
| Office-based Specialist in vascular medecine | |
| MANTES LA JOLIE, France, 78200 | |
| Office-based Specialist in vascular medecine | |
| MARCQ EN BAROEUL, France, 59700 | |
| Office-based Specialist in vascular medecine | |
| MARSEILLE, France, 13000 | |
| Office-based Specialist in vascular medecine | |
| MAUREPAS, France, 78310 | |
| Office-based Specialist in vascular medecine | |
| MEAUX, France, 77100 | |
| Office-based Specialist in vascular medecine | |
| METZ, France, 57000 | |
| Office-based Specialist in vascular medecine | |
| MEUDON, France, 92190 | |
| Office-based Specialist in vascular medecine | |
| MOISSAC, France, 82200 | |
| Office-based Specialist in vascular medecine | |
| MONTAIGU, France, 85600 | |
| Office-based Specialist in vascular medecine | |
| MONTBELIARD, France, 25200 | |
| Office-based Specialist in vascular medecine | |
| MONTLUCON, France, 03100 | |
| Office-based Specialist in vascular medecine | |
| MONTPELLIER, France, 34000 | |
| Office-based Specialist in vascular medecine | |
| MULHOUSE, France, 68100 | |
| Office-based Specialist in vascular medecine | |
| NANCY, France, 54000 | |
| Office-based Specialist in vascular medecine | |
| NANTES, France, 44000 | |
| Office-based Specialist in vascular medecine | |
| NARBONNE, France, 11100 | |
| Office-based Specialist in vascular medecine | |
| NICE, France, 06000 | |
| Office-based Specialist in vascular medecine | |
| NIMES, France, 30000 | |
| Office-based Specialist in vascular medecine | |
| NIORT, France, 79000 | |
| Office-based Specialist in vascular medecine | |
| DENAIN, France, 59220 | |
| Office-based Specialist in vascular medecine | |
| NOYAL PONTIVY, France, 56920 | |
| Office-based Specialist in vascular medecine | |
| NOYON, France, 60400 | |
| Office-based Specialist in vascular medecine | |
| ORANGE, France, 84100 | |
| Office-based Specialist in vascular medecine | |
| ORLEANS, France, 45000 | |
| Office-based Specialist in vascular medecine | |
| PARIS, France, 75000 | |
| Office-based Specialist in vascular medecine | |
| PERONNE, France, 80200 | |
| Office-based Specialist in vascular medecine | |
| PESSAC, France, 33600 | |
| Office-based Specialist in vascular medecine | |
| POISSY, France, 78300 | |
| Office-based Specialist in vascular medecine | |
| POITIERS, France, 86000 | |
| Office-based Specialist in vascular medecine | |
| PONTARLIER, France, 25300 | |
| Office-based Specialist in vascular medecine | |
| PORNIC, France, 44210 | |
| Office-based Specialist in vascular medecine | |
| PUILBOREAU, France, 17000 | |
| Office-based Specialist in vascular medecine | |
| QUIMPER, France, 29000 | |
| Office-based Specialist in vascular medecine | |
| RAMBOUILLET, France, 78120 | |
| Office-based Specialist in vascular medecine | |
| REDON, France, 35600 | |
| Office-based Specialist in vascular medecine | |
| REIMS, France, 51200 | |
| Office-based Specialist in vascular medecine | |
| RIOM, France, 63200 | |
| Office-based Specialist in vascular medecine | |
| RIVESALTES, France, 66600 | |
| Office-based Specialist in vascular medecine | |
| ROCHEFORT, France, 17300 | |
| Office-based Specialist in vascular medecine | |
| RODEZ, France, 12000 | |
| Office-based Specialist in vascular medecine | |
| ROMANS SUR ISERE, France, 26000 | |
| Office-based Specialist in vascular medecine | |
| ROUEN, France, 76000 | |
| Office-based Specialist in vascular medecine | |
| SABLE SUR SARTHE, France, 72300 | |
| Office-based Specialist in vascular medecine | |
| SAINT AUBIN DE MEDOC, France, 33160 | |
| Office-based Specialist in vascular medecine | |
| SAINT BENOIT, France, 86200 | |
| Office-based Specialist in vascular medecine | |
| SAINT BRIEUC, France, 22000 | |
| Office-based Specialist in vascular medecine | |
| SAINT CLOUD, France, 92210 | |
| Office-based Specialist in vascular medecine | |
| SAINT EGREVE, France, 38120 | |
| Office-based Specialist in vascular medecine | |
| SAINT ETIENNE, France, 42000 | |
| Office-based Specialist in vascular medecine | |
| VENDOME, France, 41100 | |
| Office-based Specialist in vascular medecine | |
| SAINT LO, France, 50000 | |
| Office-based Specialist in vascular medecine | |
| SAINT MARTIN BOULOGNE, France, 62280 | |
| Office-based Specialist in vascular medecine | |
| SAINT PIERRE (ILE DE LA REUNION), France, 97410 | |
| Office-based Specialist in vascular medecine | |
| SAINT PRIEST, France, 69800 | |
| Office-based Specialist in vascular medecine | |
| SAINT GENEVIEVE DES BOIS, France, 91700 | |
| Office-based Specialist in vascular medecine | |
| SALLANCHES, France, 74700 | |
| Office-based Specialist in vascular medecine | |
| SALON DE PROVENCE, France, 13300 | |
| Office-based Specialist in vascular medecine | |
| SARCELLES, France, 95200 | |
| Office-based Specialist in vascular medecine | |
| SARREBOURG, France, 57400 | |
| Office-based Specialist in vascular medecine | |
| SARREGUEMINES, France, 57200 | |
| Office-based Specialist in vascular medecine | |
| SAVERNE, France, 67700 | |
| Office-based Specialist in vascular medecine | |
| SAVIGNY SUR ORGE, France, 91600 | |
| Office-based Specialist in vascular medecine | |
| SCEAUX, France, 92330 | |
| Office-based Specialist in vascular medecine | |
| SELESTAT, France, 67600 | |
| Office-based Specialist in vascular medecine | |
| SEVRES, France, 92310 | |
| Office-based Specialist in vascular medecine | |
| SAINT CHAMOND, France, 42400 | |
| Office-based Specialist in vascular medecine | |
| SAINT CYR L'ECOLE, France, 78210 | |
| Office-based Specialist in vascular medecine | |
| SAINT GERMAIN EN LAYE, France, 78100 | |
| Office-based Specialist in vascular medecine | |
| STRASBOURG, France, 67000 | |
| Office-based Specialist in vascular medecine | |
| TALANT, France, 21000 | |
| Office-based Specialist in vascular medecine | |
| TARARE, France, 69170 | |
| Office-based Specialist in vascular medecine | |
| TOULOUSE, France, 31000 | |
| Office-based Specialist in vascular medecine | |
| TOURS, France, 37000 | |
| Office-based Specialist in vascular medecine | |
| TROIS RIVIERES (GUADELOUPE), France, 97114 | |
| Office-based Specialist in vascular medecine | |
| TROYES, France, 10000 | |
| Office-based Specialist in vascular medecine | |
| VALENCE, France, 26000 | |
| Office-based Specialist in vascular medecine | |
| VANNES, France, 56000 | |
| Office-based Specialist in vascular medecine | |
| SAINT GAUDENS, France, 31800 | |
| Office-based Specialist in vascular medecine | |
| VENISSIEUX, France, 69200 | |
| Office-based Specialist in vascular medecine | |
| VERRIERES LE BUISSON, France, 91370 | |
| Office-based Specialist in vascular medecine | |
| VERSAILLES, France, 78000 | |
| Office-based Specialist in vascular medecine | |
| VESOUL, France, 70000 | |
| Office-based Specialist in vascular medecine | |
| VICHY, France, 03200 | |
| Office-based Specialist in vascular medecine | |
| VIENNE, France, 38200 | |
| Office-based Specialist in vascular medecine | |
| VILLEBON SUR YVETTE, France, 91140 | |
| Office-based Specialist in vascular medecine | |
| VILLEFRANCHE SUR SAONE, France, 69400 | |
| Office-based Specialist in vascular medecine | |
| VILLEMOISSON SUR ORGE, France, 91360 | |
| Office-based Specialist in vascular medecine | |
| VILLEURBANNE, France, 69100 | |
| Office-based Specialist in vascular medecine | |
| VINCENNES, France, 94300 | |
| Office-based Specialist in vascular medecine | |
| VIROFLAY, France, 78220 | |
| Office-based Specialist in vascular medecine | |
| VIZILLE, France, 38220 | |
| Office-based Specialist in vascular medecine | |
| VOIRON, France, 38500 | |
| Office-based Specialist in vascular medecine | |
| WISSEMBOURG, France, 67160 | |
| Hospital St ANDRE | |
| BORDEAUX, France | |
| University Hospital La Cavale Blanche | |
| BREST, France | |
| Hospital St Eloi | |
| MONTPELLIER, France | |
| Hospital | |
| AUCH, France | |
| Hospital Jacques Monod | |
| MONTIVILLIERS, France | |
| University Hospital | |
| LYON, France | |
| Hospital | |
| SAINT QUENTIN, France | |
| University Hospital | |
| AMIENS, France | |
| General Hospital | |
| ABBEVILLE, France | |
| University Hospital | |
| ANGERS, France | |
| Hospital | |
| ANNECY, France | |
| Hospital | |
| ARMENTIERES, France | |
| University Hospital | |
| BELFORT, France | |
| Office-based Specialist in vascular medecine | |
| WIZERNES, France, 62570 | |
| University Hospital | |
| CAEN, France | |
| Hospital Antoine Gayraud | |
| CARCASSONNE, France | |
| Hospital | |
| CHAMBERY, France | |
| Hospital Hotel Dieu | |
| CLERMONT FERRAND, France | |
| General Hospital | |
| COMPIEGNE, France | |
| Hospital Bocage | |
| DIJON, France | |
| University Hospital | |
| DIJON, France | |
| Hospital | |
| FLERS, France | |
| Hospital | |
| MONTLUCON, France | |
| Departemental Hospital | |
| LA ROCHE SUR YON, France | |
| Hospital Versailles | |
| LE CHESNAY, France | |
| Hospital Saint Philibert | |
| LOMME, France | |
| Hospital Edouard Herriot | |
| LYON, France | |
| General Hospital | |
| MONTBELIARD, France | |
| Hospital Val d'Ariege | |
| FOIX, France | |
| Hospital | |
| MONTMORILLON, France | |
| Regional Hospital | |
| ORLEANS LA SOURCE, France | |
| Hospital Croix Saint Simon | |
| PARIS, France | |
| Hospital | |
| PERIGUEUX, France | |
| University Hospital | |
| SAINT ETIENNE, France | |
| Hospital | |
| RODEZ, France, MD | |
| University Hospital | |
| REIMS, France | |
| Cmc Les Petites Roches | |
| SAINT HILAIRE DU TOUVERT, France | |
| Memorial Hospital | |
| SAINT LO, France | |
| Regional University Hospital | |
| STRASBOURG, France | |
| University Hospital Rangueil Larrey | |
| TOULOUSE, France | |
| University Hospital Rangueil | |
| TOULOUSE, France | |
| University Hospital | |
| TOULOUSE, France | |
| Guadeloupe | |
| Office-based Specialist in vascular medecine | |
| BASSE TERRE, Guadeloupe, 97100 | |
| Principal Investigator: | Jean Luc JB BOSSON, MD | University Hospital, Grenoble |
| Study Chair: | Marie Antoinette SEVESTRE, MD | University Hospital Amiens |
More Information
| Responsible Party: | University Hospital of Grenoble ( Jean Luc Bosson ) |
| Study ID Numbers: | DCIC-04-02 |
| Study First Received: | April 30, 2008 |
| Last Updated: | May 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00670540 History of Changes |
| Health Authority: | France: French Data Protection Authority |
|
pulmonary embolism duplex ultrasound examination recurrence |
|
Embolism and Thrombosis Vasculitis Peripheral Vascular Diseases Pulmonary Embolism Respiratory Tract Diseases Embolism |
Lung Diseases Venous Insufficiency Phlebitis Vascular Diseases Cardiovascular Diseases Thrombosis |
