Working… Menu

Epidemiology of Thromboembolism Disease: A Cohort Study (OPTIMEV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00670540
Recruitment Status : Completed
First Posted : May 2, 2008
Results First Posted : May 3, 2012
Last Update Posted : May 8, 2012
Ministry of Health, France
SFMV (Société Française de Médecine Vasculaire)
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

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

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 8256 participants
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
Study Start Date : November 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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:
  • VTE (venous thromboembolism)
  • DVT (deep vein thrombosis)
  • PE (pulmonary embolism)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Percentage of Participants Who Developed Major Bleeding Events [ Time Frame: at 3 years ]
  2. Percentage of Participants With Treatment Anticoagulant Prescribed [ Time Frame: after inclusion ]
  3. Percentage of Participants Who Developed Cardiovascular Events [ Time Frame: at 3 years ]
  4. Percentage of Participants Who Died From Any Cause [ Time Frame: at 3 years ]
  5. Percentage of Participants Who Developed Cancer Onset [ Time Frame: at 3 years ]
  6. Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer) [ Time Frame: at 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00670540

Show Show 231 study locations
Sponsors and Collaborators
University Hospital, Grenoble
Ministry of Health, France
SFMV (Société Française de Médecine Vasculaire)
Layout table for investigator information
Principal Investigator: Jean Luc JB BOSSON, MD University Hospital, Grenoble
Study Chair: Marie Antoinette SEVESTRE, MD Amiens University Hospital
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Grenoble Identifier: NCT00670540    
Other Study ID Numbers: DCIC-04-02
First Posted: May 2, 2008    Key Record Dates
Results First Posted: May 3, 2012
Last Update Posted: May 8, 2012
Last Verified: May 2012
Keywords provided by University Hospital, Grenoble:
pulmonary embolism
duplex ultrasound examination
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Vascular Diseases
Venous Insufficiency
Embolism and Thrombosis
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Peripheral Vascular Diseases