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

18 Years
Not Enrolling
Vascular Diseases, Embolism and Thrombosis, Phlebitis, Venous Insufficiency, Pulmonary Embolism

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Trial Information

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

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.

Inclusion Criteria:

- patient aged more than 18

- male or female

- patients with clinical thromboembolic signs (deep vein thrombosis or pulmonary

Exclusion Criteria:

- patient less than 18 years old

- patient unable to understand

- patient who refused to participate

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)

Outcome Description:

new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.

Outcome Time Frame:

at 3 years

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Grenoble


France: French Data Protection Authority

Study ID:




Start Date:

November 2004

Completion Date:

February 2010

Related Keywords:

  • Vascular Diseases
  • Embolism and Thrombosis
  • Phlebitis
  • Venous Insufficiency
  • Pulmonary Embolism
  • pulmonary embolism
  • duplex ultrasound examination
  • recurrence
  • Embolism
  • Phlebitis
  • Pulmonary Embolism
  • Thrombosis
  • Vascular Diseases
  • Venous Insufficiency
  • Embolism and Thrombosis
  • Venous Thrombosis