Pulmonary Embolism Clinical Trial
— VTE-IDOfficial title:
Venous Thrombo-Embolism Imaging Database
Verified date | February 2024 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Brest University Hospital | Brest | Finistere |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
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 |
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