Epidemiology of Thromboembolism Disease: A Cohort Study

Completed

Conditions: Embolism and Thrombosis
Vascular Diseases
Phlebitis
Venous Insufficiency
Pulmonary Embolism

Brief Summary: The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied

1. do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ?

2. Is it necessary to obtain a detailed history of thromboembolic disease ?

3. Do older patients have particular risk factors ?

4. Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ?

5. Do predictive clinical scores have the same performance for both in and outpatients ?

6. Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?

7. The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.

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.

Recruitment & Eligibility

Inclusion Criteria

patient aged more than 18
male or female
patients with clinical thromboembolic signs (deep vein thrombosis or pulmonary embolism)

Exclusion Criteria

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)	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.

Secondary Outcome Measures

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

Locations (25): University Hospital ND des Bruyeres Liege
🇧🇪
Chenee, Belgium
General Hospital
🇫🇷
Montbeliard, France
Office-based Specialist in vascular medecine
🇬🇵
Basse Terre, Guadeloupe
University Hospital
🇫🇷
Toulouse, France
Hospital
🇫🇷
Saint Quentin, France
Hospital St ANDRE
🇫🇷
Bordeaux, France
University Hospital La Cavale Blanche
🇫🇷
Brest, France
Hospital Antoine Gayraud
🇫🇷
Carcassonne, France
Hospital Hotel Dieu
🇫🇷
Clermont Ferrand, France
Hospital Bocage
🇫🇷
Dijon, France
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University Hospital ND des Bruyeres Liege
🇧🇪Chenee, Belgium