An observational study in Vascular Diseases, Embolism and Thrombosis and Phlebitis, sponsored by University Hospital, Grenoble. Completed at 231 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-08.
Sponsored by University Hospital, Grenoble · Observational
The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied
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.
694 studies on the registry are indexed under Vascular Diseases; 128 are open to participants now.
This study's enrollment of 8,256 is above the median of 200 across 218 observational studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Also known as: VTE (venous thromboembolism), DVT (deep vein thrombosis), PE (pulmonary embolism)
Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)
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
Percentage of Participants Who Developed Major Bleeding Events
Time frame: at 3 years
Percentage of Participants With Treatment Anticoagulant Prescribed
Time frame: after inclusion
Percentage of Participants Who Developed Cardiovascular Events
Time frame: at 3 years
Percentage of Participants Who Died From Any Cause
Time frame: at 3 years
Percentage of Participants Who Developed Cancer Onset
Time frame: at 3 years
Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)
Time frame: at 3 years
| Milestone | OPTIMEV |
|---|---|
| Started | 8256 |
| Completed | 4931 |
| Not completed | 3325 |
| Withdrew: Ineligible | 17 |
| Withdrew: Not living in france | 348 |
| Withdrew: Refused to participate | 189 |
| Withdrew: Controls randomised for no follow up | 2770 |
| Withdrew: Missing information inclusion criteria | 1 |
new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.
| percentage of participants | OPTIMEV |
|---|---|
| Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE) | 8.94 (8.14 to 9.83) |
| percentage of participants | OPTIMEV |
|---|---|
| Percentage of Participants Who Developed Major Bleeding Events | 3.00 (2.54 to 3.54) |
| percentage of participants | OPTIMEV |
|---|---|
| Percentage of Participants With Treatment Anticoagulant Prescribed | 52.23 (50.82 to 53.63) |
| percentage of participants | OPTIMEV |
|---|---|
| Percentage of Participants Who Developed Cardiovascular Events | 6.98 (6.26 to 7.77) |
| percentage of participants | OPTIMEV |
|---|---|
| Percentage of Participants Who Died From Any Cause | 17.0 (15.9 to 18.0) |
| percentage of participants | OPTIMEV |
|---|---|
| Percentage of Participants Who Developed Cancer Onset | 4.10 (3.56 to 4.73) |
| percentage of participants | OPTIMEV |
|---|---|
| Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer) | 0.34 (0.20 to 0.55) |
Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OPTIMEV | — | 1,147/4,931 (23.3%) | 273/4,931 (5.5%) |
| Event | OPTIMEV |
|---|---|
| deathGeneral disorders | 822/4931 |
| cardiovascularCardiac disorders | 310/4931 |
| cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 182/4931 |
| haemorrhageBlood and lymphatic system disorders | 135/4931 |
| Pulmonary Embolism (PE)Vascular disorders | 122/4931 |
| Event | OPTIMEV |
|---|---|
| Deep Vein Thrombosis (DVT)Vascular disorders | 186/4931 |
| Superficial Vein Thrombosis (SVT)Vascular disorders | 81/4931 |
| Upper Deep Vein ThrombosisVascular disorders | 6/4931 |
| Age Continuous(years) | OPTIMEV |
|---|---|
| Mean | 62 ± 18 |
| Sex: Female, Male(Participants) | OPTIMEV |
|---|---|
| Female | 5063 |
| Male | 3193 |
| Region of Enrollment(participants) | OPTIMEV |
|---|---|
| France | 7908 |
| Guadeloupe | 321 |
| Belgium | 27 |
Showing the first 100 of 231 sites across 3 countries. Choose a country and city above to see the rest.
The record gives a start of Nov 2004, a primary completion of Jan 2009 and a completion of Feb 2010. It does not say whether these dates are actual or estimated.
Results were first posted in May 2012, 3 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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