About this trial
Venous thromboembolism (VTE) with its two clinical manifestations deep vein thrombosis (DVT) and pulmonary embolism (PE) is a life-threatening disease that is associated with considerable morbidity and mortality. The incidence of VTE increases with age and it - as the third most common cardiovascular disease after ischemic heart disease and stroke - represents an important public health problem in industrialized countries with several aspects in need to be addressed.
VTEval Project includes three long-term prospective observational studies to evaluate and improve VTE diagnostics and management, treatment and outcome. The aims of the project include a systematic assessment of VTE, i.e. disease status (symptoms, clinical and subclinical aspects) and risk profiles (classic, psychosocial and environmental factors), using a system-oriented approach. VTEval collects three large prospective cohorts of patients with suspected and incident VTE consisting of individuals with a clinical suspicion of acute PE, individuals with a clinical suspicion of acute DVT, and individuals with incidental diagnosis of VTE).
The standardized and harmonized data acquisition of the study establishes a sustainable resource for comprehensive research on VTE, thus providing the basis for both short- and long-term analysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years and Informed written consent
Cohort 1: Clinical suspicion of acute PE (with or without DVT)
Cohort 2: Clinical suspicion of acute DVT (without symptomatic PE)
Cohort 3: Incidentally diagnosed VTE
Disqualifiers
None
Trial population
Individuals either with clinically suspected or incident diagnosis of VTE
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Mortality
Overall mortality, consisting of: * PE-related death * All other causes of death
Symptomatic venous thromboembolism
Composed by: * PE-related death * Development or recurrence of nonfatal PE * Development or recurrence of DVT
Secondary outcomes
Hemodynamic instability
Defined as at least one of the following: * Cardiopulmonary resuscitation (CPR) or defibrillation * Cardiogenic shock or need of catecholamine administration * Systolic blood pressure \< 90mm Hg, or a pressure drop by more than 40mm Hg for \>15 min
Use of mechanical ventilation
Admission to Intensive Care Unit (ICU)
Recurrence of acute PE
Sponsors and contacts
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Johannes Gutenberg University Mainz
Lead sponsor
Maastricht University
Collaborator
Hochschule Fresenius
Collaborator
University of Bonn
Collaborator
Siemens Corporation, Corporate Technology
Collaborator
Bayer
Collaborator
Eurofins
Collaborator