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| Name | Class |
|---|---|
| Maastricht University | OTHER |
| Hochschule Fresenius | OTHER |
| University of Bonn | OTHER |
| Siemens Corporation, Corporate Technology |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Suspect of Pulmonary Embolism (PE) | |||
| Cohort 2: Suspect of Deep Vein Thrombosis (DVT) | |||
| Cohort 3: Incidental Venous Thromboembolism (VTE) |
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Overall mortality, consisting of:
| Baseline |
| Symptomatic venous thromboembolism | Composed by:
| Assessment at month 3, 6 and 12; year 2-6 (Active follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic instability | Defined as at least one of the following:
| Baseline |
| Use of mechanical ventilation |
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Inclusion Criteria:
Age ≥18 years and Informed written consent
Clinical condition:
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Individuals either with clinically suspected or incident diagnosis of VTE
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philipp S Wild, MD, MSc | Contact | 0049 6131 17 7163 | philipp.wild@unimedizin-mainz.de |
| Name | Affiliation | Role |
|---|---|---|
| Philipp S Wild, MD, MSc | University Medical Center of Johannes Gutenberg University Mainz, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center of the Johannes Gutenberg University Mainz | Recruiting | Mainz | Rhineland-Palatinate | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32217063 | Derived | 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. | |
| 26133379 |
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| INDUSTRY |
| Bayer | INDUSTRY |
| Eurofins | INDUSTRY |
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Serum, Na-Citrated Plasma, EDTA-Plasma, DNA, RNA
| 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) |
| Derived |
| 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 VTEval Project. BMJ Open. 2015 Jul 1;5(7):e008157. doi: 10.1136/bmjopen-2015-008157. |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
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