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Epidemiology of Thromboembolism Disease: A Cohort Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00670540
Acronym
OPTIMEV
Enrollment
8256
Registered
2008-05-02
Start date
2004-11-30
Completion date
2010-02-28
Last updated
2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolism and Thrombosis, Phlebitis, Pulmonary Embolism, Vascular Diseases, Venous Insufficiency

Keywords

pulmonary embolism, duplex ultrasound examination, recurrence

Brief summary

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.

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.

Interventions

OTHERprocedure 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

Sponsors

Sanofi
CollaboratorINDUSTRY
Ministry of Health, France
CollaboratorOTHER_GOV
SFMV (Société Française de Médecine Vasculaire)
CollaboratorUNKNOWN
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)at 3 yearsnew VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.

Secondary

MeasureTime frame
Percentage of Participants With Treatment Anticoagulant Prescribedafter inclusion
Percentage of Participants Who Developed Cardiovascular Eventsat 3 years
Percentage of Participants Who Developed Major Bleeding Eventsat 3 years
Percentage of Participants Who Developed Cancer Onsetat 3 years
Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)at 3 years
Percentage of Participants Who Died From Any Causeat 3 years

Countries

Belgium, France, Guadeloupe

Participant flow

Participants by arm

ArmCount
OPTIMEV
patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
8,256
Total8,256

Withdrawals & dropouts

PeriodReasonFG000
Overall Studycontrols randomised for no follow up2,770
Overall Studyineligible17
Overall Studymissing information inclusion criteria1
Overall Studynot living in France348
Overall Studyrefused to participate189

Baseline characteristics

CharacteristicOPTIMEV
Age Continuous62 years
STANDARD_DEVIATION 18
Region of Enrollment
Belgium
27 participants
Region of Enrollment
France
7908 participants
Region of Enrollment
Guadeloupe
321 participants
Sex: Female, Male
Female
5063 Participants
Sex: Female, Male
Male
3193 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
273 / 4,931
serious
Total, serious adverse events
1,147 / 4,931

Outcome results

Primary

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

ArmMeasureValue (NUMBER)
OPTIMEVPercentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)8.94 percentage of participants
Secondary

Percentage of Participants Who Developed Cancer Onset

Time frame: at 3 years

ArmMeasureValue (NUMBER)
OPTIMEVPercentage of Participants Who Developed Cancer Onset4.10 percentage of participants
Secondary

Percentage of Participants Who Developed Cardiovascular Events

Time frame: at 3 years

ArmMeasureValue (NUMBER)
OPTIMEVPercentage of Participants Who Developed Cardiovascular Events6.98 percentage of participants
Secondary

Percentage of Participants Who Developed Major Bleeding Events

Time frame: at 3 years

ArmMeasureValue (NUMBER)
OPTIMEVPercentage of Participants Who Developed Major Bleeding Events3.00 percentage of participants
Secondary

Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)

Time frame: at 3 years

ArmMeasureValue (NUMBER)
OPTIMEVPercentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)0.34 percentage of participants
Secondary

Percentage of Participants Who Died From Any Cause

Time frame: at 3 years

ArmMeasureValue (NUMBER)
OPTIMEVPercentage of Participants Who Died From Any Cause17.0 percentage of participants
Secondary

Percentage of Participants With Treatment Anticoagulant Prescribed

Time frame: after inclusion

ArmMeasureValue (NUMBER)
OPTIMEVPercentage of Participants With Treatment Anticoagulant Prescribed52.23 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026