Venous Thrombo-Embolism Imaging Database (VTE-ID) (VTE-ID)

Venous Thrombo-Embolism Imaging Database

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 2208

Contacts and Locations

Study Locations

• France
  • Finistere
    • Brest, Finistere, France, 29200
      • Brest University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Every patients included in the EDITH cohort between November 2009 and Novembre 2019, with a confirmed diagnosis of VTE.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VTE recurrence	VTE recurrence, including Pulmonary Embolism and Deep Vein Trombosis	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)	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At enrollment

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): February 14, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Venous thromboembolism; Radiomics; Image processing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: 29BRC20.0326 - VTE-ID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No