Visual Universitätsmedizin Mainz

VTEval-Projekt

A prospective cohort study to evaluate the diagnosis, management and outcomes in patients with venous thromboembolism

  • Study director:

    • Univ.-Prof. Dr. med. Philipp Wild, M.Sc.

Subject

Venous thromboembolism (VTE): deep vein thrombosis (DVT) and pulmonary embolism (LAE)

Study design

Observational, prospective, long-term cohort study

Study participants

Patients at least 18 years of age with a suspected VTE event (informed written consent is required)

  • Cohort 1: clinical suspicion of acute LAE (with or without DVT)
  • Cohort 2: clinical suspicion of acute DVT (without symptomatic LAE)
  • Cohort 3: incidentally diagnosed VTE

Status

Ongoing
Recruiting since 2013

Objectives

  • Evaluation of new clinical management strategies and improvement of VTE diagnosis

    • Evaluation of humoral biomarkers, noninvasive imaging parameters, systems biology and risk factors for the diagnosis of acute VTE
    • Optimizing pathways for best practice management of VTE and generating assessments for clinical decision making

  • Evaluation of VTE outcomes and improvement of risk stratification

    • Identification of markers for risk stratification and prognosis of VTE
    • Risk ratios for primary and secondary VTE
    • Identification of determinants of VTE complications
    • Incidence of cardiovascular and noncardiovascular events after VTE
    • Analysis of the VTE risk profile, outcomes and prognosis in relation to comorbidities, differences between the sexes, ethnic minorities and geriatrics
    • Evaluation of subclinical disease phenotypes in VTE

  • Establishment of a long-term resource for comprehensive research in VTE

    • Development of a documentation system for high quality and standardized data collection for clinical and scientific purposes, including a quality management system
    • Establishment of a large prospective cohort of individuals with suspected asymptomatic and symptomatic VTE
    • Establishment of a large-scale biobanking with highly standardized methods
    • Expansion of the project to a multicenter cohort using a modular approach

Study procedure

  • Duration of study per participant: 6 years

    • Disease-induced check-ups up to two years after event
    • Telephone interviews up to six years after inclusion (seven interviews max))

Summary

Venous thromboembolism (VTE) is a life-threatening condition and is considered a major public health problem in developed countries. Despite many years of research on VTE, some aspects, such as the risk profile for cardiovascular disease, have not yet received detailed attention.

In order to provide clinical and scientific evidence on the above topics, the Center of Thrombosis and Hemostasis (CTH) - a model center supporting research, treatment and medical education in thrombosis and hemostasis at UMCM - designed the VTEval project.

The VTEval project is a prospective long-term observational study to evaluate and improve VTE diagnosis, clinical management, outcomes and treatment. The goal is a systematic assessment of the disease, including disease status (symptoms, clinical and subclinical aspects), risk profile (classical, psychosocial and environmental factors) and systems biology. Standardized and harmonized data collection creates a sustainable resource for comprehensive VTE research that will be used for both short- and long-term analysis.

Knowledge of VTE is of great importance as it will help improve clinical decision making, clinical surveillance as well as the establishment of specific prevention programs. This will improve the prognosis as well as the quality of life of the population.

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