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Epidemiology of Thromboembolism Disease: A Cohort Study (OPTIMEV)

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ClinicalTrials.gov Identifier: NCT00670540
Recruitment Status : Completed
First Posted : May 2, 2008
Results First Posted : May 3, 2012
Last Update Posted : May 8, 2012
Sponsor:
Collaborators:
Sanofi
Ministry of Health, France
SFMV (Société Française de Médecine Vasculaire)
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Vascular Diseases
Embolism and Thrombosis
Phlebitis
Venous Insufficiency
Pulmonary Embolism
Intervention Other: procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis
Enrollment 8256
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OPTIMEV
Hide Arm/Group Description patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Period Title: Overall Study
Started 8256
Completed 4931 [1]
Not Completed 3325
Reason Not Completed
ineligible             17
not living in France             348
refused to participate             189
controls randomised for no follow up             2770
missing information inclusion criteria             1
[1]
total recruited for the follow up
Arm/Group Title OPTIMEV
Hide Arm/Group Description patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Overall Number of Baseline Participants 8256
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8256 participants
62  (18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8256 participants
Female
5063
  61.3%
Male
3193
  38.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8256 participants
France 7908
Guadeloupe 321
Belgium 27
1.Primary Outcome
Title Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)
Hide Description new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.
Time Frame at 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OPTIMEV
Hide Arm/Group Description:
patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Overall Number of Participants Analyzed 4931
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.94
(8.14 to 9.83)
2.Secondary Outcome
Title Percentage of Participants Who Developed Major Bleeding Events
Hide Description [Not Specified]
Time Frame at 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OPTIMEV
Hide Arm/Group Description:
patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Overall Number of Participants Analyzed 4931
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.00
(2.54 to 3.54)
3.Secondary Outcome
Title Percentage of Participants With Treatment Anticoagulant Prescribed
Hide Description [Not Specified]
Time Frame after inclusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OPTIMEV
Hide Arm/Group Description:
patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Overall Number of Participants Analyzed 4931
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.23
(50.82 to 53.63)
4.Secondary Outcome
Title Percentage of Participants Who Developed Cardiovascular Events
Hide Description [Not Specified]
Time Frame at 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OPTIMEV
Hide Arm/Group Description:
patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Overall Number of Participants Analyzed 4931
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.98
(6.26 to 7.77)
5.Secondary Outcome
Title Percentage of Participants Who Died From Any Cause
Hide Description [Not Specified]
Time Frame at 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OPTIMEV
Hide Arm/Group Description:
patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Overall Number of Participants Analyzed 4931
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17.0
(15.9 to 18.0)
6.Secondary Outcome
Title Percentage of Participants Who Developed Cancer Onset
Hide Description [Not Specified]
Time Frame at 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OPTIMEV
Hide Arm/Group Description:
patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Overall Number of Participants Analyzed 4931
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.10
(3.56 to 4.73)
7.Secondary Outcome
Title Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)
Hide Description [Not Specified]
Time Frame at 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OPTIMEV
Hide Arm/Group Description:
patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Overall Number of Participants Analyzed 4931
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.34
(0.20 to 0.55)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OPTIMEV
Hide Arm/Group Description patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
All-Cause Mortality
OPTIMEV
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OPTIMEV
Affected / at Risk (%)
Total   1147/4931 (23.26%) 
Blood and lymphatic system disorders   
haemorrhage  [1]  135/4931 (2.74%) 
Cardiac disorders   
cardiovascular  [1]  310/4931 (6.29%) 
General disorders   
death  [1]  822/4931 (16.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
cancer  [1]  182/4931 (3.69%) 
Vascular disorders   
Pulmonary Embolism (PE)  [2]  122/4931 (2.47%) 
Indicates events were collected by systematic assessment
[1]
Validation by an expert committee
[2]
Pulmonary Embolism (PE) with Deep Vein Thrombosis (DVT) or not. Validation by an expert committee
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
OPTIMEV
Affected / at Risk (%)
Total   273/4931 (5.54%) 
Vascular disorders   
Deep Vein Thrombosis (DVT)  [1]  186/4931 (3.77%) 
Superficial Vein Thrombosis (SVT)  [1]  81/4931 (1.64%) 
Upper Deep Vein Thrombosis  [1]  6/4931 (0.12%) 
Indicates events were collected by systematic assessment
[1]
Validation by an expert committee
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The protocol OPTIMEV will follow the international recommendations: "Uniforms Requirements for Manuscripts Submitted to Biomedical Journals" (http://www.icmje.org)
Results Point of Contact
Name/Title: Jean-Luc Bosson
Organization: University Hospital Grenoble
Phone: 33 4 76 76 50 40
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00670540     History of Changes
Other Study ID Numbers: DCIC-04-02
First Submitted: April 30, 2008
First Posted: May 2, 2008
Results First Submitted: February 9, 2012
Results First Posted: May 3, 2012
Last Update Posted: May 8, 2012