Epidemiology of Thromboembolism Disease: A Cohort Study (OPTIMEV)

May 4, 2012 updated by: University Hospital, Grenoble

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

8256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chenee, Belgium
        • University Hospital ND des Bruyeres Liege
      • Abbeville, France
        • General Hospital
      • 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
        • University Hospital
      • Amiens, France, 80000
        • Office-based Specialist in vascular medecine
      • Ancenis, France, 44150
        • Office-based Specialist in vascular medecine
      • Angers, France
        • University Hospital
      • Angers, France, 49000
        • Office-based Specialist in vascular medecine
      • Annecy, France
        • Hospital
      • Annecy, France, 74000
        • Office-based Specialist in vascular medecine
      • Armentieres, France
        • Hospital
      • 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
      • Auch, France
        • Hospital
      • 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
      • Belfort, France
        • University Hospital
      • 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
      • Bordeaux, France
        • Hospital St ANDRE
      • 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
      • Brest, France
        • University Hospital La Cavale Blanche
      • 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
      • Caen, France
        • University Hospital
      • 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
      • Carcassonne, France
        • Hospital Antoine Gayraud
      • 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 En Champagne, France, 51000
        • Office-based Specialist in vascular medecine
      • Chalon Sur Saone, France, 71100
        • Office-based Specialist in vascular medecine
      • Chambery, France
        • Hospital
      • 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 Ferrand, France
        • Hospital Hôtel Dieu
      • 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
      • Compiegne, France
        • General Hospital
      • Coulommiers, France, 77120
        • Office-based Specialist in vascular medecine
      • Crolles, France, 38920
        • Office-based Specialist in vascular medecine
      • Denain, France, 59220
        • Office-based Specialist in vascular medecine
      • Dieppe, France, 76200
        • Office-based Specialist in vascular medecine
      • Dijon, France
        • University Hospital
      • Dijon, France, 21000
        • Office-based Specialist in vascular medecine
      • Dijon, France
        • Hospital Bocage
      • 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
      • Flers, France
        • Hospital
      • Foix, France, 09000
        • Office-based Specialist in vascular medecine
      • Foix, France
        • Hospital Val D'ariège
      • Fontenay Le Comte, France, 85200
        • Office-based Specialist in vascular medecine
      • Glanes, France, 46130
        • Office-based Specialist in vascular medecine
      • Grenoble, France, 38043
        • University Hospital Grenoble
      • 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
      • L'ile Rousse, France, 20220
        • Office-based Specialist in vascular medecine
      • La Roche Sur Yon, France, 85000
        • Office-based Specialist in vascular medecine
      • La Roche Sur Yon, France
        • Departemental Hospital
      • 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 Chesnay, France
        • Hospital Versailles
      • 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
      • Limoges, France, 87000
        • Office-based Specialist in vascular medecine
      • Lisieux, France, 14100
        • Office-based Specialist in vascular medecine
      • Lomme, France
        • Hospital Saint Philibert
      • 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
      • Lyon, France
        • Hospital Edouard Herriot
      • Lyon, France
        • University Hospital
      • 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
      • Martinique, France, 97000
        • 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
      • Montbeliard, France
        • General Hospital
      • Montivilliers, France
        • Hospital Jacques Monod
      • Montlucon, France, 03100
        • Office-based Specialist in vascular medecine
      • Montlucon, France
        • Hospital
      • Montmorillon, France
        • Hospital
      • Montpellier, France, 34000
        • Office-based Specialist in vascular medecine
      • Montpellier, France
        • Hospital St Eloi
      • Mulhouse, France, 68100
        • Office-based Specialist in vascular medecine
      • NOUMEA (Nouvelle Calédonie), France, 98800
        • 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
      • 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
      • Orleans La Source, France
        • Regional Hospital
      • Paris, France, 75000
        • Office-based Specialist in vascular medecine
      • Paris, France
        • Hospital Croix Saint Simon
      • Perigueux, France
        • Hospital
      • 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
      • Reims, France
        • University Hospital
      • 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
      • Rodez, France, MD
        • Hospital
      • 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 Chamond, France, 42400
        • Office-based Specialist in vascular medecine
      • Saint Cloud, France, 92210
        • Office-based Specialist in vascular medecine
      • Saint Cyr L'ecole, France, 78210
        • 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
      • Saint Etienne, France
        • University Hospital
      • Saint Gaudens, France, 31800
        • Office-based Specialist in vascular medecine
      • Saint Genevieve Des Bois, France, 91700
        • Office-based Specialist in vascular medecine
      • Saint Germain En Laye, France, 78100
        • Office-based Specialist in vascular medecine
      • Saint Hilaire Du Touvert, France
        • Cmc Les Petites Roches
      • Saint Lo, France, 50000
        • Office-based Specialist in vascular medecine
      • Saint Lo, France
        • Memorial Hospital
      • 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 Quentin, France
        • Hospital
      • 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
      • Strasbourg, France, 67000
        • Office-based Specialist in vascular medecine
      • Strasbourg, France
        • Regional University Hospital
      • Talant, France, 21000
        • Office-based Specialist in vascular medecine
      • Tarare, France, 69170
        • Office-based Specialist in vascular medecine
      • Toulouse, France
        • University Hospital
      • Toulouse, France, 31000
        • Office-based Specialist in vascular medecine
      • Toulouse, France
        • University Hospital Rangueil Larrey
      • Toulouse, France
        • University Hospital Rangueil
      • 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
      • Vendome, France, 41100
        • 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
        • Office-based Specialist in vascular medecine
      • Wizernes, France, 62570
        • Office-based Specialist in vascular medecine
      • Basse Terre, Guadeloupe, 97100
        • Office-based Specialist in vascular medecine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
patients with a clinical suspicion of Venous ThromboEmbolism (VTE = Deep Vein Thrombosis or Pulmonary Embolism) were eligible
Other Names:
  • VTE (venous thromboembolism)
  • DVT (deep vein thrombosis)
  • PE (pulmonary embolism)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)
Time Frame: at 3 years
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Developed Major Bleeding Events
Time Frame: at 3 years
at 3 years
Percentage of Participants With Treatment Anticoagulant Prescribed
Time Frame: after inclusion
after inclusion
Percentage of Participants Who Developed Cardiovascular Events
Time Frame: at 3 years
at 3 years
Percentage of Participants Who Died From Any Cause
Time Frame: at 3 years
at 3 years
Percentage of Participants Who Developed Cancer Onset
Time Frame: at 3 years
at 3 years
Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)
Time Frame: at 3 years
at 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jean Luc JB BOSSON, MD, University Hospital, Grenoble
  • Study Chair: Marie Antoinette SEVESTRE, MD, Amiens University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 2, 2008

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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