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.
Study Type
OBSERVATIONAL
Enrollment
2,000
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany
RECRUITINGMortality
Overall mortality, consisting of: * PE-related death * All other causes of death
Time frame: Baseline
Symptomatic venous thromboembolism
Composed by: * PE-related death * Development or recurrence of nonfatal PE * Development or recurrence of DVT
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
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
Time frame: Baseline
Use of mechanical ventilation
Time frame: Baseline
Admission to Intensive Care Unit (ICU)
Time frame: Baseline
Recurrence of acute PE
Time frame: Baseline
Cardiac dysfunction or heart failure
Time frame: Baseline
Pneumonia
Time frame: Baseline
Symptomatic and/or asymptomatic DVT
Time frame: Baseline
Major bleeding
Time frame: Baseline
Clinically relevant non-major bleedings
Time frame: Baseline
Diagnostic of a previously unknown malignancy
Time frame: Baseline
Length of hospitalization
Time frame: Baseline
Implantation of vena cava filter
Time frame: Baseline
Thrombolytic treatment
Time frame: Baseline
Interventional treatment
Time frame: Baseline
Surgery
Time frame: Baseline
Overall mortality
Time frame: Assessment at month 3/6 and 12; year 2-6 (Active follow-up)
PE-related death
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development or recurrence of clinical symptomatic PE/DVT
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Asymptomatic DVT
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Chronic venous insufficiency (CVI)
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Post-thrombotic Syndrome (PTS)
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development of cardiac dysfunction or heart failure
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development of pulmonary hypertension
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Respiratory dysfunction
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Major bleeding
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Clinically relevant non-major bleedings
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Diagnostic of a previously unknown malignancy
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Net clinical outcome (NCO)
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
O2 home treatment
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Pulmonary vasoactive drugs
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Hospitalization
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Length of stay in Hospital due to VTE
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Major adverse cardiac and cerebrovascular event (MACCE)
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Cardiovascular event
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Cerebrovascular event
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
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