Clinical Trial: Epidemiology of Thromboembolism Disease: A Cohort Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary:

The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied

  1. 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) ?
  2. Is it necessary to obtain a detailed history of thromboembolic disease ?
  3. Do older patients have particular risk factors ?
  4. Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ?
  5. Do predictive clinical scores have the same performance for both in and outpatients ?
  6. Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?
  7. The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.

Detailed Summary: 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.
Sponsor: University Hospital, Grenoble

Current Primary Outcome: 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.


Original Primary Outcome: development or recurrence of VTE [ Time Frame: at 3 months, 1, 2 and 3 years ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • major bleeding events [ Time Frame: at 3 months, 1, 2 and 3 years ]
  • treatments prescribed (type + duration) [ Time Frame: at 3 months, 1, 2 and 3 years ]
  • cardiovascular events [ Time Frame: at 3 months, 1, 2 and 3 years ]
  • all causes of death [ Time Frame: at 3 months, 1, 2 and 3 years ]
  • cancer onset [ Time Frame: at 3 months, 1, 2 and 3 years ]
  • Venous Insufficiency (leg ulcer) [ Time Frame: 3 months, 1, 2 and 3 years ]


Information By: University Hospital, Grenoble

Dates:
Date Received: April 30, 2008
Date Started: November 2004
Date Completion:
Last Updated: May 4, 2012
Last Verified: May 2012