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Completed

NCT Number: NCT06258694

Venous Thrombo-Embolism Imaging Database (VTE-ID)

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Deep Vein Thrombosis Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brest University Hospital

Brest, Finistere, 29200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. VTE recurrence

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

    VTE recurrence, including Pulmonary Embolism and Deep Vein Trombosis

  2. Distinguishing provoked from unprovoked VTE

    Time frame: 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 outcomes

  1. Individual phenotyping

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Venous Thrombo-Embolism Imaging Database

Acronym: VTE-ID

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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