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Completed OBSERVATIONAL NCT00670540

Epidemiology of Thromboembolism Disease: A Cohort Study (OPTIMEV)

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

Sponsor: Ministry of Health, France

Updated 8 times since 2017 Last updated: May 4, 2012 Started: Nov 30, 2004 Primary completion: Jan 31, 2009 Completion: Feb 28, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Embolism and Thrombosis and Phlebitis, this trial is completed. The trial is conducted by Ministry of Health, France and has accumulated 8 data snapshots since 2004. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshotCompleted~Oct 2025 – present · 6 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Oct 2025 — Present [monthly]

    Completed

  2. Sep 2025 — Oct 2025 [monthly]

    Completed

  3. Sep 2024 — Sep 2025 [monthly]

    Completed

  4. Jul 2024 — Sep 2024 [monthly]

    Completed

  5. Jan 2021 — Jul 2024 [monthly]

    Completed

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed

  2. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

  3. Jan 2017 — Apr 2018 [monthly]

    Completed NA

    First recorded

Nov 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Ministry of Health, France
  • SFMV (Société Française de Médecine Vasculaire)
  • Sanofi
  • University Hospital, Grenoble
Data source: University Hospital, Grenoble

For direct contact, visit the study record on ClinicalTrials.gov .