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

NCT ID: NCT02156401

Last Updated: 2024-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2030-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Thromboembolism (VTE) Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: Suspect of Pulmonary Embolism (PE)

No interventions assigned to this group

Cohort 2: Suspect of Deep Vein Thrombosis (DVT)

No interventions assigned to this group

Cohort 3: Incidental Venous Thromboembolism (VTE)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University

OTHER

Sponsor Role collaborator

Hochschule Fresenius

OTHER

Sponsor Role collaborator

University of Bonn

OTHER

Sponsor Role collaborator

Siemens Corporation, Corporate Technology

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

Eurofins

INDUSTRY

Sponsor Role collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Philipp Wild, MD, MSc

Univ.-Prof. Dr. med. Philipp Wild, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philipp S Wild, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University Medical Center of Johannes Gutenberg University Mainz, Germany

Locations

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University Medical Center of the Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Philipp S Wild, MD, MSc

Role: CONTACT

0049 6131 17 7163

Facility Contacts

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Philipp S Wild, MD, MSc

Role: primary

00496131177163

References

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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.

Reference Type DERIVED
PMID: 32217063 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26133379 (View on PubMed)

Other Identifiers

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UMCM-2013EPI02

Identifier Type: -

Identifier Source: org_study_id

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