Venous Thrombo-Embolism Imaging Database (VTE-ID)

Venous Thrombo-Embolism Imaging Database

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06258694

Acronym

VTE-ID

Enrollment

2208

Registered

2024-02-14

Start date

2021-01-14

Completion date

2021-02-15

Last updated

2024-02-14

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

Conditions

Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

Keywords

Venous thromboembolism, Image processing, Radiomics

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
VTE recurrence	At enrollment (retrospective follow up to 2 years)	VTE recurrence, including Pulmonary Embolism and Deep Vein Trombosis
Distinguishing provoked from unprovoked VTE	At enrollment	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)

Secondary

Measure	Time frame	Description
Individual phenotyping	At enrollment	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).

Countries

France

Outcome results