Epidemiology of Thromboembolism Disease: A Cohort Study - Full Text View

Sponsors and Collaborators:	University Hospital, Grenoble Sanofi-Aventis Ministry of Health, France SFMV (Société Française de Médecine Vasculaire)
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00670540

Purpose

The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied

do different types of thromboembolic disease (distal DVT, proximal DVT, PE and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ?
Is it necessary to obtain a detailed history of thromboembolic disease ?
Do older patients have particular risk factors ?
Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease

?
Do predictive clinical scores have the same performance for both in and outpatients ?
Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?
The evolution of the disease in patients with negative or positive VTE exploratory tests.

Condition	Intervention
Vascular Diseases Embolism and Thrombosis Phlebitis Venous Insufficiency Pulmonary Embolism	Other: procedure of DVT and PE diagnosis

Study Type:	Observational
Study Design:	Cohort, 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:

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism Vascular Diseases

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

development or recurrence of VTE [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

major bleeding events [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
treatments prescribed (type + duration) [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
cardiovascular events [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
all causes of death [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
cancer onset [ Time Frame: at 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
Venous Insufficiency (leg ulcer) [ Time Frame: 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	8256
Study Start Date:	November 2004
Estimated Study Completion Date:	June 2009
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 patients with suspected VTE or PE	Other: procedure of DVT and PE diagnosis patients with a clinical suspicion of VTE (deep vein thrombosis or pulmonary embolism) were eligible

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 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 or pulmonary embolism.

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

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

Show 231 Study Locations

Sponsors and Collaborators

University Hospital, Grenoble

Sanofi-Aventis

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	University Hospital Amiens

More Information

Additional Information:

please click on the link OPTIMEV to see the site created for communication about the study during recruitment and afterwards This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8.

Samama MM. An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: the Sirius study. Arch Intern Med. 2000 Dec 11-25;160(22):3415-20.

Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER) Lancet. 1999 Apr 24;353(9162):1386-9.

Stein PD, Hull RD, Ghali WA, Patel KC, Olson RE, Meyers FA, Kalra NK. Tracking the uptake of evidence: two decades of hospital practice trends for diagnosing deep vein thrombosis and pulmonary embolism. Arch Intern Med. 2003 May 26;163(10):1213-9.

Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quéré I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study] J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. French.

Responsible Party:	University Hospital of Grenoble ( Jean Luc Bosson )
Study ID Numbers:	DCIC-04-02
Study First Received:	April 30, 2008
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00670540 History of Changes
Health Authority:	France: French Data Protection Authority

Keywords provided by University Hospital, Grenoble:

pulmonary embolism
duplex ultrasound examination
recurrence

Study placed in the following topic categories:

Pulmonary Embolism
Peripheral Vascular Diseases
Vasculitis
Vascular Diseases
Thrombosis
Thromboembolism
Recurrence

Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Lung Diseases
Venous Insufficiency
Phlebitis
Venous Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Vasculitis
Peripheral Vascular Diseases
Pulmonary Embolism
Respiratory Tract Diseases
Embolism

Lung Diseases
Venous Insufficiency
Phlebitis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on September 03, 2009