Isolated Pulmonary Embolism Is Associated With a High Risk of Arterial Thrombotic Disease: Results From the VTEval Study.
Vincent Ten Cate, Lisa Eggebrecht, Andreas Schulz...
https://pubmed.ncbi.nlm.nih.gov/32217063Actively Recruiting
Age: 18Years +
All Genders
ID02156401
VTEval Project - Three Observational, Prospective Cohort Studies Including Biobanking to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in Venous Thromboembolism
Led by Johannes Gutenberg University Mainz · Updated on 2024-06-17
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johannes Gutenberg University Mainz
Lead Sponsor
M
Maastricht University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is a serious condition causing significant illness and death. It is a common cardiovascular disease, especially in older adults, and poses a major public health challenge in developed countries. This research project, called VTEval, aims to improve how VTE is diagnosed, managed, and treated by studying patients over a long period. The VTEval Project consists of three separate observational studies following groups of patients suspected to have acute PE, acute DVT, or those with an incidental diagnosis of VTE. There are no experimental treatments administered; instead, the project collects detailed data and biological samples to better understand the disease and its risk factors using a system-oriented approach. Participants will be monitored through regular assessments at baseline and follow-up visits at 3, 6, 12 months, and up to 6 years. Researchers will evaluate outcomes such as mortality, symptomatic VTE events, bleeding complications, heart and lung function, and hospitalizations. This long-term follow-up will help provide comprehensive insights into VTE outcomes and support improved care strategies.
CONDITIONS
Brief Title
VTEval Project - Prospective Cohort Studies to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in VTE
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Provide informed written consent
- For Cohort 1: Clinical suspicion of acute pulmonary embolism (PE), with or without deep vein thrombosis (DVT)
- For Cohort 2: Clinical suspicion of acute deep vein thrombosis (DVT) without symptomatic PE
- For Cohort 3: Incidentally diagnosed venous thromboembolism (VTE)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Baseline period
Participants undergo diagnostic evaluations for suspected pulmonary embolism, deep vein thrombosis, or incidental venous thromboembolism.
1 to 2 visits depending on cohort assignment
Long-term Monitoring
Duration - Up to 6 years
Participants are monitored over several years to assess health outcomes including symptomatic and asymptomatic venous thromboembolism, cardiac and respiratory function, bleeding events, and other related conditions.
Follow-up assessments at month 3, 6, and 12, then yearly visits up to year 6
Trial Site Locations
Total: 1 location
1
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
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Research Team
P
Philipp S Wild, MD, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
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.
Bernd Frank, Liana Ariza, Heidrun Lamparter...
https://pubmed.ncbi.nlm.nih.gov/26133379