Epidemiology of Thromboembolism Disease: A Cohort Study (OPTIMEV)
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism |
- Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE) [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Percentage of Participants With Treatment Anticoagulant Prescribed [ Time Frame: after inclusion ] [ Designated as safety issue: Yes ]
- Percentage of Participants Who Developed Cardiovascular Events [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
- Percentage of Participants Who Died From Any Cause [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
- Percentage of Participants Who Developed Cancer Onset [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
- Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer) [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 8256 |
| Study Start Date: | November 2004 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
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
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All male or female inpatients and outpatients hospital and office-based. 18 years old with clinical suspicion of deep vein thrombosis (DVT) or pulmonary embolism (PE).
Patients with cognitive disorders or language impairment preventing collection of risk factor data by history-taking were excluded.
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
Contacts and Locations
Show 231 Study Locations| Principal Investigator: | Jean Luc JB BOSSON, MD | University Hospital, Grenoble |
| Study Chair: | Marie Antoinette SEVESTRE, MD | Amiens University Hospital |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT00670540 History of Changes |
| Other Study ID Numbers: | DCIC-04-02 |
| Study First Received: | April 30, 2008 |
| Results First Received: | February 9, 2012 |
| Last Updated: | May 4, 2012 |
| Health Authority: | France: French Data Protection Authority |
Keywords provided by University Hospital, Grenoble:
|
pulmonary embolism duplex ultrasound examination recurrence |
Additional relevant MeSH terms:
|
Embolism Phlebitis Pulmonary Embolism Thrombosis Vascular Diseases Venous Insufficiency Embolism and Thrombosis |
Venous Thrombosis Cardiovascular Diseases Peripheral Vascular Diseases Vasculitis Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013