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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00670540 |
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Date of registration:
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30/04/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Epidemiology of Thromboembolism Disease: A Cohort Study
OPTIMEV |
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Scientific title:
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A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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8256 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00670540 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Belgium
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France
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Guadeloupe
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Contacts
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Name:
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Jean Luc JB BOSSON, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Grenoble |
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Name:
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Marie Antoinette SEVESTRE, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Amiens University Hospital |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Embolism and Thrombosis
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Pulmonary Embolism
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Phlebitis
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Vascular Diseases
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Venous Insufficiency
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Intervention(s)
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Other: procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis
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Primary Outcome(s)
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Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)
[Time Frame: at 3 years]
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Secondary Outcome(s)
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Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)
[Time Frame: at 3 years]
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Percentage of Participants Who Developed Cancer Onset
[Time Frame: at 3 years]
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Percentage of Participants Who Developed Cardiovascular Events
[Time Frame: at 3 years]
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Percentage of Participants Who Developed Major Bleeding Events
[Time Frame: at 3 years]
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Percentage of Participants Who Died From Any Cause
[Time Frame: at 3 years]
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Percentage of Participants With Treatment Anticoagulant Prescribed
[Time Frame: after inclusion]
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Secondary ID(s)
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DCIC-04-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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