VTEval Project - Prospective Cohort Studies to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in VTE

Study Overview
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Brief Summary
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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.

Official Title
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VTEval Project - Three Observational, Prospective Cohort Studies Including Biobanking to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in Venous Thromboembolism

Conditions
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Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and Informed written consent Clinical condition: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: Suspect of Pulmonary Embolism (PE)<br> | |
| Cohort 2: Suspect of Deep Vein Thrombosis (DVT)<br> | |
| Cohort 3: Incidental Venous Thromboembolism (VTE)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Overall mortality, consisting of: PE-related death All other causes of death | Baseline | 
| Symptomatic venous thromboembolism | Composed by: PE-related death Development or recurrence of nonfatal PE Development or recurrence of DVT | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline | 
| Use of mechanical ventilation |  | Baseline | 
| Admission to Intensive Care Unit (ICU) |  | Baseline | 
| Recurrence of acute PE |  | Baseline | 
| Cardiac dysfunction or heart failure |  | Baseline | 
| Pneumonia |  | Baseline | 
| Symptomatic and/or asymptomatic DVT |  | Baseline | 
| Major bleeding |  | Baseline | 
| Clinically relevant non-major bleedings |  | Baseline | 
| Diagnostic of a previously unknown malignancy |  | Baseline | 
| Length of hospitalization |  | Baseline | 
| Implantation of vena cava filter |  | Baseline | 
| Thrombolytic treatment |  | Baseline | 
| Interventional treatment |  | Baseline | 
| Surgery |  | Baseline | 
| Overall mortality |  | Assessment at month 3/6 and 12; year 2-6 (Active follow-up) | 
| PE-related death |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Development or recurrence of clinical symptomatic PE/DVT |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Asymptomatic DVT |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Chronic venous insufficiency (CVI) |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Post-thrombotic Syndrome (PTS) |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Development of cardiac dysfunction or heart failure |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Development of pulmonary hypertension |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Respiratory dysfunction |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Major bleeding |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Clinically relevant non-major bleedings |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Diagnostic of a previously unknown malignancy |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Net clinical outcome (NCO) |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| O2 home treatment |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Pulmonary vasoactive drugs |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Development of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Hospitalization |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Length of stay in Hospital due to VTE |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Major adverse cardiac and cerebrovascular event (MACCE) |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Cardiovascular event |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 
| Cerebrovascular event |  | Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous thromboembolism, Deep vein thrombosis, Pulmonary embolism, Cohort study/epidemiology, Outcome, Prognosis