Trial record 6 of 1163 for:    "Embolism and Thrombosis"

Epidemiology of Thromboembolism Disease: A Cohort Study (OPTIMEV)

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Ministry of Health, France
SFMV (Société Française de Médecine Vasculaire)
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00670540
First received: April 30, 2008
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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 Intervention
Vascular Diseases
Embolism and Thrombosis
Phlebitis
Venous Insufficiency
Pulmonary Embolism
Other: procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE) [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
    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:
  • Percentage of Participants Who Developed Major Bleeding Events [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Treatment Anticoagulant Prescribed [ Time Frame: after inclusion ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Developed Cardiovascular Events [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Died From Any Cause [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Developed Cancer Onset [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer) [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 8256
Study Start Date: November 2004
Study Completion Date: February 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670540

  Show 231 Study Locations
Sponsors and Collaborators
University Hospital, Grenoble
Sanofi
Ministry of Health, France
SFMV (Société Française de Médecine Vasculaire)
Investigators
Principal Investigator: Jean Luc JB BOSSON, MD University Hospital, Grenoble
Study Chair: Marie Antoinette SEVESTRE, MD Amiens University Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00670540     History of Changes
Other Study ID Numbers: DCIC-04-02
Study First Received: April 30, 2008
Results First Received: February 9, 2012
Last Updated: May 4, 2012
Health Authority: France: French Data Protection Authority

Keywords provided by University Hospital, Grenoble:
pulmonary embolism
duplex ultrasound examination
recurrence

Additional relevant MeSH terms:
Embolism and Thrombosis
Embolism
Phlebitis
Pulmonary Embolism
Thrombosis
Vascular Diseases
Venous Insufficiency
Venous Thrombosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vasculitis
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014