Venous Thrombo-Embolism Imaging Database (VTE-ID)

Completed

• Conditions: Pulmonary Embolism; Venous Thromboembolism; Deep Vein Thrombosis

• Registration Number: NCT06258694
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study Start: 2021-01-14
• Study First Submitted: 2021-01-29
• Primary Completion: 2021-02-14
• Study Completion: 2021-02-15
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2208

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Brest University Hospital; 🇫🇷 Brest, Finistere, France