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

Sponsor

Johannes Gutenberg University Mainz (Other)

Overall Status

Recruiting

CT.gov ID

NCT02156401

Collaborator

Maastricht University (Other), Hochschule Fresenius (Other), University of Bonn (Other), Siemens Corporation, Corporate Technology (Industry), Bayer (Industry), Eurofins (Industry)

2,000

Enrollment

Location

123

Anticipated Duration (Months)

16.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism (VTE) Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE)

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1: Suspect of Pulmonary Embolism (PE)
Cohort 2: Suspect of Deep Vein Thrombosis (DVT)
Cohort 3: Incidental Venous Thromboembolism (VTE)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Hemodynamic instability [Baseline]
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 [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)]