| April 30, 2008 |
| May 16, 2008 |
| November 2004 |
| June 2006 (final data collection date for primary outcome measure) |
| development or recurrence of VTE [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00670540 on ClinicalTrials.gov Archive Site |
- major bleeding events [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
- treatments prescribed (type + duration) [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
- cardiovascular events [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
- all causes of death [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
- cancer onset [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
- Venous Insufficiency (leg ulcer) [ Time Frame: 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Epidemiology of Thromboembolism Disease: A Cohort Study |
| A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism |
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 DVT, proximal DVT, 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 VTE exploratory tests.
|
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 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. |
| |
| Observational |
| Cohort, Prospective |
- Vascular Diseases
- Embolism and Thrombosis
- Phlebitis
- Venous Insufficiency
- Pulmonary Embolism
|
| Other: procedure of DVT and PE diagnosis |
| patients with suspected VTE or PE |
- Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8.
- Samama MM. An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: the Sirius study. Arch Intern Med. 2000 Dec 11-25;160(22):3415-20.
- Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER) Lancet. 1999 Apr 24;353(9162):1386-9.
- Stein PD, Hull RD, Ghali WA, Patel KC, Olson RE, Meyers FA, Kalra NK. Tracking the uptake of evidence: two decades of hospital practice trends for diagnosing deep vein thrombosis and pulmonary embolism. Arch Intern Med. 2003 May 26;163(10):1213-9.
- Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quéré I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study] J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. French.
|
| |
| Active, not recruiting |
| 8256 |
| June 2009 |
| June 2006 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, France, Guadeloupe |
| |
| NCT00670540 |
| Jean Luc Bosson, University Hospital of Grenoble |
| DCIC-04-02 |
| University Hospital, Grenoble |
- Sanofi-Aventis
- Ministry of Health, France
- SFMV (Société Française de Médecine Vasculaire)
|
| Principal Investigator: |
Jean Luc JB BOSSON, MD |
University Hospital, Grenoble |
|
| Study Chair: |
Marie Antoinette SEVESTRE, MD |
University Hospital Amiens |
|
|
| University Hospital, Grenoble |
| May 2008 |