Epidemiology of Thromboembolism Disease: A Cohort Study

Study Overview
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Brief Summary
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The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied 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) ? Is it necessary to obtain a detailed history of thromboembolic disease ? Do older patients have particular risk factors ? Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ? Do predictive clinical scores have the same performance for both in and outpatients ? Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ? The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Other: procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) | Other: procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis<br>* patients with a clinical suspicion of Venous ThromboEmbolism (VTE = Deep Vein Thrombosis or Pulmonary Embolism) were eligible<br>* Other names: PE (pulmonary embolism);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Developed Major Bleeding Events |  | at 3 years | 
| Percentage of Participants With Treatment Anticoagulant Prescribed |  | after inclusion | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary embolism, duplex ultrasound examination, recurrence