Epidemiology of Thromboembolism Disease: A Cohort Study (OPTIMEV)
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|ClinicalTrials.gov Identifier: NCT00670540|
Recruitment Status : Completed
First Posted : May 2, 2008
Results First Posted : May 3, 2012
Last Update Posted : May 8, 2012
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.
|Condition or disease||Intervention/treatment|
|Vascular Diseases Embolism and Thrombosis Phlebitis Venous Insufficiency Pulmonary Embolism||Other: procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis|
|Study Type :||Observational|
|Actual Enrollment :||8256 participants|
|Official Title:||A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||February 2010|
patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
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
- 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.
- Percentage of Participants Who Developed Major Bleeding Events [ Time Frame: at 3 years ]
- Percentage of Participants With Treatment Anticoagulant Prescribed [ Time Frame: after inclusion ]
- Percentage of Participants Who Developed Cardiovascular Events [ Time Frame: at 3 years ]
- Percentage of Participants Who Died From Any Cause [ Time Frame: at 3 years ]
- Percentage of Participants Who Developed Cancer Onset [ Time Frame: at 3 years ]
- Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer) [ Time Frame: at 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670540
|Principal Investigator:||Jean Luc JB BOSSON, MD||University Hospital, Grenoble|
|Study Chair:||Marie Antoinette SEVESTRE, MD||Amiens University Hospital|