NCT00670540

Epidemiology of Thromboembolism Disease: A Cohort Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8,256 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Diseases
• Embolism and Thrombosis
• Phlebitis
• Venous Insufficiency
• Pulmonary Embolism

Interventions

Type	Name	Description
OTHER	procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis	patients with a clinical suspicion of Venous ThromboEmbolism (VTE = Deep Vein Thrombosis or Pulmonary Embolism) were eligible

Timeline

• Start date: 2004-11-01
• Primary completion: 2009-01-01
• Completion: 2010-02-01
• First posted: 2008-05-02
• Last updated: 2012-05-08
• Results posted: 2012-05-03

Locations

231 sites across 3 countries: Belgium, France, Guadeloupe