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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohannes Gutenberg University Mainz

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 3 trial groups
Group A: Cohort 1: Suspect of Pulmonary Embolism (PE)
Group B: Cohort 2: Suspect of Deep Vein Thrombosis (DVT)
Group C: Cohort 3: Incidental Venous Thromboembolism (VTE)

Trial outcomes

Primary outcomes

1

Mortality

Overall mortality, consisting of: * PE-related death * All other causes of death

Time frame
Baseline
2

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)

Secondary outcomes

1

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
2

Use of mechanical ventilation

Time frame
Baseline
3

Admission to Intensive Care Unit (ICU)

Time frame
Baseline
4

Recurrence of acute PE

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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