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

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Thromboembolism (VTE); Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE)

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Philipp S Wild, MD, MSc; Phone Number: 0049 6131 17 7163; Email: philipp.wild@unimedizin-mainz.de

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Recruiting
      • University Medical Center of the Johannes Gutenberg University Mainz
      • Contact: Philipp S Wild, MD, MSc; Phone Number: 00496131177163; Email: philipp.wild@unimedizin-mainz.de
      • Principal Investigator: Philipp S Wild, MD, MSc
      • Principal Investigator: Stavros Konstantinides, MD, FESC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals either with clinically suspected or incident diagnosis of VTE

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Cohort 1: Suspect of Pulmonary Embolism (PE)
Cohort 2: Suspect of Deep Vein Thrombosis (DVT)
Cohort 3: Incidental Venous Thromboembolism (VTE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline
Use of mechanical ventilation		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)

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Collaborators: Bayer; Maastricht University; University of Bonn; Siemens Corporation, Corporate Technology; Eurofins; Hochschule Fresenius
• Investigators: Principal Investigator: Philipp S Wild, MD, MSc, University Medical Center of Johannes Gutenberg University Mainz, Germany

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2013
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: May 23, 2014
• First Submitted That Met QC Criteria: June 3, 2014
• First Posted (ESTIMATE): June 5, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Prognosis; Deep vein thrombosis; Outcome; Pulmonary embolism; Venous thromboembolism; Cohort study/epidemiology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: UMCM-2013EPI02