Venous Thrombo-Embolism Imaging Database (VTE-ID)

University Hospital, Brest2,208 enrolled

Overview

The purpose of this study is to identify and validate new imaging biomarkers allowing an individual phenotyping of patient with venous thrombo-embolism (VTE), mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. To do so, the investigators will create a retrospective imaging database including multiple imaging modalities, performed at diagnosis of the VTE.

Using a large imaging data in VTE (including ultrasound, CT-scan and Ventilation/Perfusion lung scan), the investigators will search for association between imaging data and VTE phenotypes, mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. Then, using a radiomic approach, the investigators will try to identify new imaging biomarkers able to provide an individual phenotyping in these patients. These imaging biomarkers will be validated using an internal cross validation technique.

Study Type

OBSERVATIONAL

Enrollment

2,208

Conditions

Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older. * Confirmed VTE diagnosis (deep vein thrombosis or pulmonary embolism). * Inclusion in the EDITH (Etude des Déterminants et Interaction de la THrombose veineuse) between November 2009 and November 2019. * No opposition to be included in the present study. Exclusion Criteria: * Patients under 18 years old. * Patients under judicial protection. * Patient physically or cognitively unable to give consent. * Refusal to participate.

Locations (1)

Brest University Hospital

Brest, Finistere, France

Outcomes

Primary Outcomes

VTE recurrence

VTE recurrence, including Pulmonary Embolism and Deep Vein Trombosis

Time frame: At enrollment (retrospective follow up to 2 years)

Distinguishing provoked from unprovoked VTE

Provoked VTE is defined by the presence within the three past months, of a major risk factor (i.e. Surgery, Immobilization \> 3 days, Hormonal Treatment, Pregnancy, Cancer)

Time frame: At enrollment

Secondary Outcomes

Individual phenotyping

Correlation of the identified biomarkers with VTE phenotypes (familial history, risk factor in case of provoked VTE, and biological biomarkers as fibrinogen, D Dimeres, Hemoglobin, Platelets, CRP, heterozygous or homozygous FV Leiden, Prothrombin G20210A).

Time frame: At enrollment

Data from ClinicalTrials.gov

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