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

NCT02156401 | Recruiting

• 1 other identifier: UMCM-2013EPI02
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Keywords

Venous thromboembolism; Deep vein thrombosis; Pulmonary embolism; Cohort study/epidemiology; Outcome; Prognosis

Outcome Measures

Primary Outcomes (2)

• Mortality

  Overall mortality, consisting of: * PE-related death * All other causes of death

  Baseline

• Symptomatic venous thromboembolism

  Composed by: * PE-related death * Development or recurrence of nonfatal PE * Development or recurrence of DVT

  Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)

Secondary Outcomes (36)

• Hemodynamic instability

  Baseline

• Use of mechanical ventilation

  Baseline

• Admission to Intensive Care Unit (ICU)

  Baseline

• Recurrence of acute PE

  Baseline

• Cardiac dysfunction or heart failure

  Baseline

Study Arms (3)

Cohort 1: Suspect of Pulmonary Embolism (PE)

Cohort 2: Suspect of Deep Vein Thrombosis (DVT)

Cohort 3: Incidental Venous Thromboembolism (VTE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals either with clinically suspected or incident diagnosis of VTE

You may qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Maastricht University: collaborator
• Hochschule Fresenius: collaborator
• University of Bonn: collaborator
• Siemens Corporation, Corporate Technology: collaborator
• Bayer: collaborator
• Eurofins: collaborator

Study Sites (1)

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Related Publications (2)

• 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 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.

  PMID: 26133379 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Na-Citrated Plasma, EDTA-Plasma, DNA, RNA

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Philipp S Wild, MD, MSc

  University Medical Center of Johannes Gutenberg University Mainz, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp S Wild, MD, MSc

CONTACT

0049 6131 17 7163; philipp.wild@unimedizin-mainz.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med. Philipp Wild, MSc

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 5, 2014
• Study Start: April 1, 2013
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

DE (1)