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Incidence of Superficial Vein Thrombosis (STEPH)

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ClinicalTrials.gov Identifier: NCT01501175
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : February 13, 2013
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
To date, the investigators still do not know the annual incidence of Superficial Vein Thrombosis in the legs, although the investigators do know that this pathology is frequent and the investigators can assume its incidence is greater than Deep Vein Thrombosis which is of 1 to 2 cases per year per 1,000 inhabitants. Furthermore, the high percentage of SVT with concomitant DVT and Pulmonary Embolism only concerns patients seen in vascular medicine, so it is important to re-evaluate this rate on an unselected population from general practice.

Condition or disease Intervention/treatment
Superficial Vein Thrombosis Other: consultation with a vascular physician

Detailed Description:
The method is a prospective observational study involving all the general practitioners and vascular physicians of the Saint Etienne region, i.e. 276 general practitioners, 27 vascular physicians and 341,822 inhabitants. Any new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician would be listed over one year. The confirmed SVTs, directly seen by the vascular physicians would also be listed. The incidence would be calculated by relating the total number of SVTs observed to the number of inhabitants of the Saint Etienne region. Information on whether concomitant DVT exists or not at the time of the compression ultrasonography would also be collected.

Study Type : Observational
Actual Enrollment : 848 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Annual Incidence of Superficial Vein Thrombosis in the Legs
Study Start Date : November 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
patients with suspected SVT
patients with suspected SVT and inhabitants of the Saint Etienne region
Other: consultation with a vascular physician
As in usual practice, patient with suspected SVT will consult a vascular physician to diagnose SVT and eventually DVP/PE associated. Vascular physician will collect risk factors of SVT.



Primary Outcome Measures :
  1. symptomatic SVT [ Time Frame: 1 year ]
    new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician


Secondary Outcome Measures :
  1. SVT risk factors [ Time Frame: 1 year ]
    SVT risk factors will be collected during consultation with vascular physician. They are: varicose veins, history of thromboembolism, autoimmune disease,cancer, immobilization, recent surgery

  2. SVT Clinical signs [ Time Frame: 1 year ]
    SVT clinical signs will be collected during consultation with general practitioner and or vascular physician. They are: palpable cords, pain, erythematous area and surrounding edema.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with suspected SVT inhabitant of the Saint Etienne region
Criteria

Inclusion Criteria:

  • inhabitants of the Saint Etienne region
  • with suspected SVT
  • consulting general practitioners and or vascular physicians of the Saint Etienne region

Exclusion Criteria:

  • SVT not confirmed by compression ultrasonography

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501175


Locations
France
Cabinet D'Angiologie
Firminy, France, 42700
Ch Firminy
Firminy, France, 42700
Cabinet D'Angiologie
Saint Chamond, France, 42400
Cabinet D'Angiologie
Saint Etienne, France, 42000
Centre médical de Chavannes
Saint-chamond, France, 42400
Cabinet D'Angiologie
Saint-etienne, France, 42000
Chu Saint-Etienne
Saint-etienne, France, 42000
Clinique Mutualiste CHirurgicale de St-Etienne
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Hervé DECOUSUS, MD PhD CHU SAINT-ETIENNE
Study Director: Paul FRAPPE, MD University of Saint Etienne
Study Director: Bernard TARDY, MD PhD CHU de Saint Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01501175     History of Changes
Other Study ID Numbers: 1108036
11.385 ( Other Identifier: CCTIRS )
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
superficial vein thrombosis
Saint Etienne region

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases