VTEval Project - Prospective Cohort Studies to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in VTE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
VTEval Project - Three Observational, Prospective Cohort Studies Including Biobanking to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in Venous Thromboembolism
Overview
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.
Primary outcome measures
- Mortality [Time frame: Baseline]
- Symptomatic venous thromboembolism [Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)]
Secondary outcome measures (12)
- Hemodynamic instability [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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Medical Center of the Johannes Gutenberg University Mainz — Mainz
Publications
- Ten Cate V, Eggebrecht L, Schulz A, Panova-Noeva M, Lenz M, Koeck T, Rapp S, Arnold N, Lackner KJ, Konstantinides S, Espinola-Klein C, Munzel T, Prochaska JH, Wild PS. Isolated Pulmonary Embolism Is Associated With a High Risk of Arterial Thrombotic Disease: Results From the VTEval Study. Chest. 2020 Jul;158(1):341-349. doi: 10.1016/j.chest.2020.01.055. Epub 2020 Mar 23. PMID 32217063
- Frank B, Ariza L, Lamparter H, Grossmann V, Prochaska JH, Ullmann A, Kindler F, Weisser G, Walter U, Lackner KJ, Espinola-Klein C, Munzel T, Konstantinides SV, Wild PS; VTEval study group. Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEv PMID 26133379
Identifiers
NCT: NCT02156401 · UMCM-2013EPI02