Skip to main content
OpenTrials
Completed

NCT Number: NCT00670540

Epidemiology of Thromboembolism Disease: A Cohort Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital ND des Bruyeres Liege, Chênée, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Ministry of Health, France
  • SFMV (Société Française de Médecine Vasculaire)
  • Sanofi

Registry information

Official study title

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

Acronym: OPTIMEV

Important dates

Study start
2004
Primary completion
2009
Study completion
2010
First posted
May 2, 2008
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.