Venous Thrombo-Embolism Imaging Database (VTE-ID)

Pulmonary Embolism Clinical Trial

— VTE-ID  

Official title:

Venous Thrombo-Embolism Imaging Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06258694
• Other study ID #: 29BRC20.0326 - VTE-ID
• Status: Completed
• Start date: January 14, 2021
• Est. completion date: February 15, 2021

Study information

• Verified date: February 2024
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2208
• Est. completion date: February 15, 2021
• Est. primary completion date: February 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
France	Brest University Hospital	Brest	Finistere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE recurrence	VTE recurrence, including Pulmonary Embolism and Deep Vein Trombosis	At enrollment (retrospective follow up to 2 years)
Primary	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	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