Venous Thromboembolism (VTE)VTEvalNCT02156401
VTEval Project - Prospective Cohort Studies to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in VTE
An observational study of Venous Thromboembolism (VTE) and Deep Vein Thrombosis (DVT), run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals either with clinically suspected or incident diagnosis of VTE
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, 55131
Philipp S Wild, MD, MSc, 00496131177163, philipp.wild@unimedizin-mainz.de
Philipp S Wild, MD, MSc
About this study
Official title: VTEval Project - Three Observational, Prospective Cohort Studies Including Biobanking to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in Venous Thromboembolism
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.
- Keywords
- Venous thromboembolism, Deep vein thrombosis, Pulmonary embolism, Cohort study/epidemiology, Outcome, Prognosis
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Suspect of Pulmonary Embolism (PE) | Not described | |
| Cohort 2: Suspect of Deep Vein Thrombosis (DVT) | Not described | |
| Cohort 3: Incidental Venous Thromboembolism (VTE) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Overall mortality, consisting of:
- PE-related death
- All other causes of death
Measured: Baseline
Symptomatic venous thromboembolism
Composed by:
- PE-related death
- Development or recurrence of nonfatal PE
- Development or recurrence of DVT
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary outcomes (36)
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
Measured: Baseline
Use of mechanical ventilation
Measured: Baseline
Admission to Intensive Care Unit (ICU)
Measured: Baseline
Recurrence of acute PE
Measured: Baseline
Cardiac dysfunction or heart failure
Measured: Baseline
Pneumonia
Measured: Baseline
Symptomatic and/or asymptomatic DVT
Measured: Baseline
Major bleeding
Measured: Baseline
Clinically relevant non-major bleedings
Measured: Baseline
Diagnostic of a previously unknown malignancy
Measured: Baseline
Length of hospitalization
Measured: Baseline
Implantation of vena cava filter
Measured: Baseline
Thrombolytic treatment
Measured: Baseline
Interventional treatment
Measured: Baseline
Surgery
Measured: Baseline
Overall mortality
Measured: Assessment at month 3/6 and 12; year 2-6 (Active follow-up)
PE-related death
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development or recurrence of clinical symptomatic PE/DVT
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Asymptomatic DVT
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Chronic venous insufficiency (CVI)
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Post-thrombotic Syndrome (PTS)
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development of cardiac dysfunction or heart failure
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development of pulmonary hypertension
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Respiratory dysfunction
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Major bleeding
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Clinically relevant non-major bleedings
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Diagnostic of a previously unknown malignancy
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Net clinical outcome (NCO)
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
O2 home treatment
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Pulmonary vasoactive drugs
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Hospitalization
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Length of stay in Hospital due to VTE
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Major adverse cardiac and cerebrovascular event (MACCE)
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Cardiovascular event
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Cerebrovascular event
Measured: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, Hochschule Fresenius, University of Bonn, Siemens Corporation, Corporate Technology, Bayer, Eurofins
- Responsible party
- Principal investigator, Philipp Wild, MD, MSc, Johannes Gutenberg University Mainz
- Investigators
- Philipp S Wild, MD, MSc, Principal investigator, University Medical Center of Johannes Gutenberg University Mainz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156401
- Sponsor's protocol ID
- UMCM-2013EPI02
- Acronym
- VTEval
- Status last verified
- Jun 2024
- First submitted
- 23 May 2014
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32217063Frank 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.
PubMed 26133379
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VTEval Project - Three Observational, Prospective Cohort Studies Including Biobanking to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT02156401
- Acronym / sponsor ID
- VTEval / UMCM-2013EPI02
- Keywords
- Venous thromboembolism, Deep vein thrombosis, Pulmonary embolism, Cohort study/epidemiology, Outcome, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Maastricht University, Hochschule Fresenius, University of Bonn, Siemens Corporation, Corporate Technology, Bayer, Eurofins
- Study start
- Apr 2013 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Suspect of Pulmonary Embolism (PE) | – | – |
| Cohort 2: Suspect of Deep Vein Thrombosis (DVT) | – | – |
| Cohort 3: Incidental Venous Thromboembolism (VTE) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals either with clinically suspected or incident diagnosis of VTE
Key inclusion criteria (5 listed)
- Age ≥18 years and Informed written consent
- Clinical condition:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Baseline
Overall mortality, consisting of: * PE-related death * All other causes of death
Symptomatic venous thromboembolism
Time frame: 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
36 secondary outcomes
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
Thrombolytic treatment
Time frame: Baseline
Interventional treatment
Time frame: Baseline
Surgery
Time frame: Baseline
Overall mortality
Time frame: Assessment at month 3/6 and 12; year 2-6 (Active follow-up)
PE-related death
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development or recurrence of clinical symptomatic PE/DVT
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Asymptomatic DVT
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Chronic venous insufficiency (CVI)
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Post-thrombotic Syndrome (PTS)
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development of cardiac dysfunction or heart failure
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development of pulmonary hypertension
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Respiratory dysfunction
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Major bleeding
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Clinically relevant non-major bleedings
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Diagnostic of a previously unknown malignancy
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Net clinical outcome (NCO)
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
O2 home treatment
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Pulmonary vasoactive drugs
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Development of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Hospitalization
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Length of stay in Hospital due to VTE
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Major adverse cardiac and cerebrovascular event (MACCE)
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Cardiovascular event
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Cerebrovascular event
Time frame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Derived from this study: PubMed 32217063Ten 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.
- Derived from this study: PubMed 26133379Frank 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philipp S Wild, MD, MSc principal investigator
University Medical Center of Johannes Gutenberg University Mainz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism (VTE) and Deep Vein Thrombosis (DVT), run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp S Wild, MD, MSc (0049 6131 17 7163, philipp.wild@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156401, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.