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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Ministry of Health, France | OTHER_GOV |
| SFMV (Société Française de Médecine Vasculaire) | UNKNOWN |
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The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis | Other | patients with a clinical suspicion of Venous ThromboEmbolism (VTE = Deep Vein Thrombosis or Pulmonary Embolism) were eligible |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Developed Major Bleeding Events | at 3 years | |
| Percentage of Participants With Treatment Anticoagulant Prescribed | after inclusion | |
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Inclusion Criteria:
Exclusion Criteria:
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All male or female inpatients and outpatients hospital and office-based. 18 years old with clinical suspicion of deep vein thrombosis (DVT) or pulmonary embolism (PE).
Patients with cognitive disorders or language impairment preventing collection of risk factor data by history-taking were excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Jean Luc JB BOSSON, MD | University Hospital, Grenoble | Principal Investigator |
| Marie Antoinette SEVESTRE, MD | Amiens University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital ND des Bruyeres Liege | Chênée | Belgium | ||||
| General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14638561 | Background | 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. | |
| 11112234 |
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| ID | Title | Description |
|---|---|---|
| FG000 | OPTIMEV | patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Percentage of Participants Who Developed Cardiovascular Events |
| at 3 years |
| Percentage of Participants Who Died From Any Cause | at 3 years |
| Percentage of Participants Who Developed Cancer Onset | at 3 years |
| Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer) | at 3 years |
| Abbeville |
| France |
| Office-based Specialist in vascular medecine | Albertville | 73200 | France |
| Office-based Specialist in vascular medecine | Albi | 81000 | France |
| Office-based Specialist in vascular medecine | Alençon | 61000 | France |
| Office-based Specialist in vascular medecine | Alès | 30100 | France |
| Office-based Specialist in vascular medecine | Ambares | 33440 | France |
| Office-based Specialist in vascular medecine | Amberieu En Buget | 01500 | France |
| Office-based Specialist in vascular medecine | Amiens | 80000 | France |
| University Hospital | Amiens | France |
| Office-based Specialist in vascular medecine | Ancenis | 44150 | France |
| Office-based Specialist in vascular medecine | Angers | 49000 | France |
| University Hospital | Angers | France |
| Office-based Specialist in vascular medecine | Annecy | 74000 | France |
| Hospital | Annecy | France |
| Hospital | Armentières | France |
| Office-based Specialist in vascular medecine | Arnouville | 95400 | France |
| Office-based Specialist in vascular medecine | Arpajon | 91290 | France |
| Office-based Specialist in vascular medecine | Arras | 62000 | France |
| Office-based Specialist in vascular medecine | Aubenas | 07200 | France |
| Hospital | Auch | France |
| Office-based Specialist in vascular medecine | Auxerre | 89000 | France |
| Office-based Specialist in vascular medecine | Bagnoles-de-l'orme | 61140 | France |
| Office-based Specialist in vascular medecine | Beauvais | 60000 | France |
| University Hospital | Belfort | France |
| Office-based Specialist in vascular medecine | Bergerac | 24100 | France |
| Office-based Specialist in vascular medecine | Besançon | 25000 | France |
| Office-based Specialist in vascular medecine | Béziers | 35500 | France |
| Office-based Specialist in vascular medecine | Blagnac | 31700 | France |
| Office-based Specialist in vascular medecine | Bordeaux | 33000 | France |
| Hospital St ANDRE | Bordeaux | France |
| Office-based Specialist in vascular medecine | Boulogne-sur-Mer | 62200 | France |
| Office-based Specialist in vascular medecine | Bourg-en-Bresse | 01000 | France |
| Office-based Specialist in vascular medecine | Bourgoin | 38300 | France |
| Office-based Specialist in vascular medecine | Brest | 29200 | France |
| University Hospital La Cavale Blanche | Brest | France |
| Office-based Specialist in vascular medecine | Bretenoux | 46130 | France |
| Office-based Specialist in vascular medecine | Brétigny-sur-Orge | 91220 | France |
| Office-based Specialist in vascular medecine | Bron | 69500 | France |
| Office-based Specialist in vascular medecine | Cabestany | 66330 | France |
| University Hospital | Caen | France |
| Office-based Specialist in vascular medecine | Caluire-et-Cuire | 69300 | France |
| Office-based Specialist in vascular medecine | Cambrai | 59400 | France |
| Office-based Specialist in vascular medecine | Cannes | 06400 | France |
| Office-based Specialist in vascular medecine | Carcassonne | 11000 | France |
| Hospital Antoine Gayraud | Carcassonne | France |
| Office-based Specialist in vascular medecine | Castanet-Tolosan | 31320 | France |
| Office-based Specialist in vascular medecine | Castres | 81100 | France |
| Office-based Specialist in vascular medecine | Cenon | 33150 | France |
| Office-based Specialist in vascular medecine | Chalon En Champagne | 51000 | France |
| Office-based Specialist in vascular medecine | Chalon-sur-Saône | 71100 | France |
| Office-based Specialist in vascular medecine | Chambéry | 73000 | France |
| Hospital | Chambéry | France |
| Office-based Specialist in vascular medecine | Champagnole | 39300 | France |
| Office-based Specialist in vascular medecine | Chantilly | 60500 | France |
| Office-based Specialist in vascular medecine | Charleville-Mézières | 08000 | France |
| Office-based Specialist in vascular medecine | Chartres | 28000 | France |
| Office-based Specialist in vascular medecine | Châteaubriant | 44110 | France |
| Office-based Specialist in vascular medecine | Cholet | 49300 | France |
| Office-based Specialist in vascular medecine | Clamart | 92140 | France |
| Office-based Specialist in vascular medecine | Clapiers | 34830 | France |
| Office-based Specialist in vascular medecine | Clermont-Ferrand | 63000 | France |
| Hospital Hotel Dieu | Clermont-Ferrand | France |
| Office-based Specialist in vascular medecine | Clermont-l'Hérault | 34800 | France |
| Office-based Specialist in vascular medecine | Clisson | 44190 | France |
| Office-based Specialist in vascular medecine | Cluses | 74300 | France |
| Office-based Specialist in vascular medecine | Colomiers | 31770 | France |
| General Hospital | Compiègne | France |
| Office-based Specialist in vascular medecine | Coulommiers | 77120 | France |
| Office-based Specialist in vascular medecine | Crolles | 38920 | France |
| Office-based Specialist in vascular medecine | Denain | 59220 | France |
| Office-based Specialist in vascular medecine | Dieppe | 76200 | France |
| Office-based Specialist in vascular medecine | Dijon | 21000 | France |
| Hospital Bocage | Dijon | France |
| University Hospital | Dijon | France |
| Office-based Specialist in vascular medecine | Draguignan | 83300 | France |
| Office-based Specialist in vascular medecine | Ermont | 95120 | France |
| Office-based Specialist in vascular medecine | Échirolles | 38130 | France |
| Office-based Specialist in vascular medecine | Évreux | 27000 | France |
| Office-based Specialist in vascular medecine | Feytiat | 87220 | France |
| Office-based Specialist in vascular medecine | Fécamp | 76400 | France |
| Office-based Specialist in vascular medecine | Figeac | 46100 | France |
| Hospital | Flers | France |
| Office-based Specialist in vascular medecine | Foix | 09000 | France |
| Hospital Val d'Ariege | Foix | France |
| Office-based Specialist in vascular medecine | Fontenay-le-Comte | 85200 | France |
| Office-based Specialist in vascular medecine | Glanes | 46130 | France |
| Office-based Specialist in vascular medecine | Grenoble | 38000 | France |
| University Hospital Grenoble | Grenoble | 38043 | France |
| Office-based Specialist in vascular medecine | Gruchet-le-Valasse | 76210 | France |
| Office-based Specialist in vascular medecine | Hœnheim | 67800 | France |
| Office-based Specialist in vascular medecine | Issy-les-Moulineaux | 92130 | France |
| Office-based Specialist in vascular medecine | Istres | 13800 | France |
| Office-based Specialist in vascular medecine | L'ÃŽle-Rousse | 20220 | France |
| Office-based Specialist in vascular medecine | La Roche-sur-Yon | 85000 | France |
| Departemental Hospital | La Roche-sur-Yon | France |
| Office-based Specialist in vascular medecine | La Rochelle | 17000 | France |
| Office-based Specialist in vascular medecine | Lannion | 22300 | France |
| Office-based Specialist in vascular medecine | Lattes | 34970 | France |
| Office-based Specialist in vascular medecine | Laval | 53000 | France |
| Office-based Specialist in vascular medecine | Laxou | 54520 | France |
| Hospital Versailles | Le Chesnay | France |
| Office-based Specialist in vascular medecine | Le Mans | 72000 | France |
| Office-based Specialist in vascular medecine | Le Quesnoy | 59530 | France |
| Office-based Specialist in vascular medecine | Levallois-Perret | 92300 | France |
| Office-based Specialist in vascular medecine | Limoges | 87000 | France |
| Office-based Specialist in vascular medecine | Lisieux | 14100 | France |
| Hospital Saint Philibert | Lomme | France |
| Office-based Specialist in vascular medecine | Longjumeau | 91160 | France |
| Office-based Specialist in vascular medecine | Longwy | 54440 | France |
| Office-based Specialist in vascular medecine | Lons-le-Saunier | 39000 | France |
| Office-based Specialist in vascular medecine | Lorient | 56100 | France |
| Office-based Specialist in vascular medecine | Louviers | 27400 | France |
| Hospital Edouard Herriot | Lyon | France |
| University Hospital | Lyon | France |
| Office-based Specialist in vascular medecine | Malemort-sur-Corrèze | 19360 | France |
| Office-based Specialist in vascular medecine | Manosque | 04100 | France |
| Office-based Specialist in vascular medecine | Mantes-la-Jolie | 78200 | France |
| Office-based Specialist in vascular medecine | Marcq-en-Barœul | 59700 | France |
| Office-based Specialist in vascular medecine | Marseille | 13000 | France |
| Office-based Specialist in vascular medecine | Martinique | 97000 | France |
| Office-based Specialist in vascular medecine | Maurepas | 78310 | France |
| Office-based Specialist in vascular medecine | Meaux | 77100 | France |
| Office-based Specialist in vascular medecine | Metz | 57000 | France |
| Office-based Specialist in vascular medecine | Meudon | 92190 | France |
| Office-based Specialist in vascular medecine | Moissac | 82200 | France |
| Office-based Specialist in vascular medecine | Montaigu | 85600 | France |
| Office-based Specialist in vascular medecine | Montbéliard | 25200 | France |
| General Hospital | Montbéliard | France |
| Hospital Jacques Monod | Montivilliers | France |
| Office-based Specialist in vascular medecine | Montluçon | 03100 | France |
| Hospital | Montluçon | France |
| Hospital | Montmorillon | France |
| Office-based Specialist in vascular medecine | Montpellier | 34000 | France |
| Hospital St Eloi | Montpellier | France |
| Office-based Specialist in vascular medecine | Mulhouse | 68100 | France |
| Office-based Specialist in vascular medecine | Nancy | 54000 | France |
| Office-based Specialist in vascular medecine | Nantes | 44000 | France |
| Office-based Specialist in vascular medecine | Narbonne | 11100 | France |
| Office-based Specialist in vascular medecine | Nice | 06000 | France |
| Office-based Specialist in vascular medecine | Niort | 79000 | France |
| Office-based Specialist in vascular medecine | Nîmes | 30000 | France |
| Office-based Specialist in vascular medecine | Noumea (Nouvelle Calédonie) | 98800 | France |
| Office-based Specialist in vascular medecine | Noyal-Pontivy | 56920 | France |
| Office-based Specialist in vascular medecine | Noyon | 60400 | France |
| Office-based Specialist in vascular medecine | Orange | 84100 | France |
| Regional Hospital | Orleans La Source | France |
| Office-based Specialist in vascular medecine | Orléans | 45000 | France |
| Office-based Specialist in vascular medecine | Paris | 75000 | France |
| Hospital Croix Saint Simon | Paris | France |
| Office-based Specialist in vascular medecine | Pessac | 33600 | France |
| Hospital | Périgueux | France |
| Office-based Specialist in vascular medecine | Péronne | 80200 | France |
| Office-based Specialist in vascular medecine | Poissy | 78300 | France |
| Office-based Specialist in vascular medecine | Poitiers | 86000 | France |
| Office-based Specialist in vascular medecine | Pontarlier | 25300 | France |
| Office-based Specialist in vascular medecine | Pornic | 44210 | France |
| Office-based Specialist in vascular medecine | Puilboreau | 17000 | France |
| Office-based Specialist in vascular medecine | Quimper | 29000 | France |
| Office-based Specialist in vascular medecine | Rambouillet | 78120 | France |
| Office-based Specialist in vascular medecine | Redon | 35600 | France |
| Office-based Specialist in vascular medecine | Reims | 51200 | France |
| University Hospital | Reims | France |
| Office-based Specialist in vascular medecine | Riom | 63200 | France |
| Office-based Specialist in vascular medecine | Rivesaltes | 66600 | France |
| Office-based Specialist in vascular medecine | Rochefort | 17300 | France |
| Office-based Specialist in vascular medecine | Rodez | 12000 | France |
| Hospital | Rodez | MD | France |
| Office-based Specialist in vascular medecine | Romans-sur-Isère | 26000 | France |
| Office-based Specialist in vascular medecine | Rouen | 76000 | France |
| Office-based Specialist in vascular medecine | Sablé-sur-Sarthe | 72300 | France |
| Office-based Specialist in vascular medecine | Saint Genevieve Des Bois | 91700 | France |
| Cmc Les Petites Roches | Saint Hilaire Du Touvert | France |
| Office-based Specialist in vascular medecine | Saint Pierre (ile de La Reunion) | 97410 | France |
| Office-based Specialist in vascular medecine | Saint-Aubin-de-Médoc | 33160 | France |
| Office-based Specialist in vascular medecine | Saint-Benoît | 86200 | France |
| Office-based Specialist in vascular medecine | Saint-Brieuc | 22000 | France |
| Office-based Specialist in vascular medecine | Saint-Chamond | 42400 | France |
| Office-based Specialist in vascular medecine | Saint-Cloud | 92210 | France |
| Office-based Specialist in vascular medecine | Saint-Cyr-l'École | 78210 | France |
| Office-based Specialist in vascular medecine | Saint-Etienne | 42000 | France |
| University Hospital | Saint-Etienne | France |
| Office-based Specialist in vascular medecine | Saint-Égrève | 38120 | France |
| Office-based Specialist in vascular medecine | Saint-Gaudens | 31800 | France |
| Office-based Specialist in vascular medecine | Saint-Germain-en-Laye | 78100 | France |
| Office-based Specialist in vascular medecine | Saint-Lô | 50000 | France |
| Memorial Hospital | Saint-Lô | France |
| Office-based Specialist in vascular medecine | Saint-Martin-Boulogne | 62280 | France |
| Office-based Specialist in vascular medecine | Saint-Priest | 69800 | France |
| Hospital | Saint-Quentin | France |
| Office-based Specialist in vascular medecine | Sallanches | 74700 | France |
| Office-based Specialist in vascular medecine | Salon-de-Provence | 13300 | France |
| Office-based Specialist in vascular medecine | Sarcelles | 95200 | France |
| Office-based Specialist in vascular medecine | Sarrebourg | 57400 | France |
| Office-based Specialist in vascular medecine | Sarreguemines | 57200 | France |
| Office-based Specialist in vascular medecine | Saverne | 67700 | France |
| Office-based Specialist in vascular medecine | Savigny-sur-Orge | 91600 | France |
| Office-based Specialist in vascular medecine | Sceaux | 92330 | France |
| Office-based Specialist in vascular medecine | Sèvres | 92310 | France |
| Office-based Specialist in vascular medecine | Sélestat | 67600 | France |
| Office-based Specialist in vascular medecine | Strasbourg | 67000 | France |
| Regional University Hospital | Strasbourg | France |
| Office-based Specialist in vascular medecine | Talant | 21000 | France |
| Office-based Specialist in vascular medecine | Tarare | 69170 | France |
| Office-based Specialist in vascular medecine | Toulouse | 31000 | France |
| University Hospital Rangueil Larrey | Toulouse | France |
| University Hospital Rangueil | Toulouse | France |
| University Hospital | Toulouse | France |
| Office-based Specialist in vascular medecine | Tours | 37000 | France |
| Office-based Specialist in vascular medecine | Trois Rivieres (guadeloupe) | 97114 | France |
| Office-based Specialist in vascular medecine | Troyes | 10000 | France |
| Office-based Specialist in vascular medecine | Valence | 26000 | France |
| Office-based Specialist in vascular medecine | Vannes | 56000 | France |
| Office-based Specialist in vascular medecine | Vendôme | 41100 | France |
| Office-based Specialist in vascular medecine | Verrières-le-Buisson | 91370 | France |
| Office-based Specialist in vascular medecine | Versailles | 78000 | France |
| Office-based Specialist in vascular medecine | Vesoul | 70000 | France |
| Office-based Specialist in vascular medecine | Vénissieux | 69200 | France |
| Office-based Specialist in vascular medecine | Vichy | 03200 | France |
| Office-based Specialist in vascular medecine | Vienne | 38200 | France |
| Office-based Specialist in vascular medecine | Villebon-sur-Yvette | 91140 | France |
| Office-based Specialist in vascular medecine | Villefranche-sur-Saône | 69400 | France |
| Office-based Specialist in vascular medecine | Villemoisson-sur-Orge | 91360 | France |
| Office-based Specialist in vascular medecine | Villeurbanne | 69100 | France |
| Office-based Specialist in vascular medecine | Vincennes | 94300 | France |
| Office-based Specialist in vascular medecine | Viroflay | 78220 | France |
| Office-based Specialist in vascular medecine | Vizille | 38220 | France |
| Office-based Specialist in vascular medecine | Voiron | 38500 | France |
| Office-based Specialist in vascular medecine | Wissembourg | 67160 | France |
| Office-based Specialist in vascular medecine | Wizernes | 62570 | France |
| Office-based Specialist in vascular medecine | Basse-Terre | 97100 | Guadeloupe |
| 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. |
| 10227218 | Background | 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. |
| 12767959 | Background | 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. |
| 16292199 | 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. |
| 25104514 | Derived | 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. |
| 25087889 | Derived | 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. |
| 22429908 | Derived | 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. |
| 20630688 | Derived | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OPTIMEV | patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | percentage of participants | at 3 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Major Bleeding Events | Posted | Number | 95% Confidence Interval | percentage of participants | at 3 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Anticoagulant Prescribed | Posted | Number | 95% Confidence Interval | percentage of participants | after inclusion |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Cardiovascular Events | Posted | Number | 95% Confidence Interval | percentage of participants | at 3 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Died From Any Cause | Posted | Number | 95% Confidence Interval | percentage of participants | at 3 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Cancer Onset | Posted | Number | 95% Confidence Interval | percentage of participants | at 3 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer) | Posted | Number | 95% Confidence Interval | percentage of participants | at 3 years |
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OPTIMEV | patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) | 1,147 | 4,931 | 273 | 4,931 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Systematic Assessment | Validation by an expert committee |
| |
| cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Validation by an expert committee |
| |
| cardiovascular | Cardiac disorders | Systematic Assessment | Validation by an expert committee |
| |
| haemorrhage | Blood and lymphatic system disorders | Systematic Assessment | Validation by an expert committee |
| |
| Pulmonary Embolism (PE) | Vascular disorders | Systematic Assessment | Pulmonary Embolism (PE) with Deep Vein Thrombosis (DVT) or not. Validation by an expert committee |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis (DVT) | Vascular disorders | Systematic Assessment | Validation by an expert committee |
| |
| Superficial Vein Thrombosis (SVT) | Vascular disorders | Systematic Assessment | Validation by an expert committee |
| |
| Upper Deep Vein Thrombosis | Vascular disorders | Systematic Assessment | Validation by an expert committee |
|
The protocol OPTIMEV will follow the international recommendations: "Uniforms Requirements for Manuscripts Submitted to Biomedical Journals" (http://www.icmje.org)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Luc Bosson | University Hospital Grenoble | 33 4 76 76 50 40 | jean-luc.bosson@imag.fr |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
| D010689 | Phlebitis |
| D014689 | Venous Insufficiency |
| D011655 | Pulmonary Embolism |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D014657 | Vasculitis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C052671 | vinyltriethoxysilane |
Not provided
Not provided
Not provided
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