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

Venous Thromboembolism (VTE) Clinical Trial

— VTEval  

Official title:

VTEval Project - Three Observational, Prospective Cohort Studies Including Biobanking to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in Venous Thromboembolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02156401
• Other study ID #: UMCM-2013EPI02
• Status: Recruiting
• Start date: April 2013
• Est. completion date: July 2023

Study information

• Verified date: March 2021
• Source: Johannes Gutenberg University Mainz
• Contact: Philipp S Wild, MD, MSc
• Phone: 0049 6131 17 7163
• Email: philipp.wild[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	University Medical Center of the Johannes Gutenberg University Mainz	Mainz	Rhineland-Palatinate

Sponsors (7)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Bayer, Eurofins, Hochschule Fresenius, Maastricht University, Siemens Corporation, Corporate Technology, University of Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Overall mortality, consisting of: PE-related death; All other causes of death	Baseline
Primary	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	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
Secondary	Use of mechanical ventilation		Baseline
Secondary	Admission to Intensive Care Unit (ICU)		Baseline
Secondary	Recurrence of acute PE		Baseline
Secondary	Cardiac dysfunction or heart failure		Baseline
Secondary	Pneumonia		Baseline
Secondary	Symptomatic and/or asymptomatic DVT		Baseline
Secondary	Major bleeding		Baseline
Secondary	Clinically relevant non-major bleedings		Baseline
Secondary	Diagnostic of a previously unknown malignancy		Baseline
Secondary	Length of hospitalization		Baseline
Secondary	Implantation of vena cava filter		Baseline
Secondary	Thrombolytic treatment		Baseline
Secondary	Interventional treatment		Baseline
Secondary	Surgery		Baseline
Secondary	Overall mortality		Assessment at month 3/6 and 12; year 2-6 (Active follow-up)
Secondary	PE-related death		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Development or recurrence of clinical symptomatic PE/DVT		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Asymptomatic DVT		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Chronic venous insufficiency (CVI)		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Post-thrombotic Syndrome (PTS)		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Development of cardiac dysfunction or heart failure		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Development of pulmonary hypertension		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Respiratory dysfunction		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Major bleeding		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Clinically relevant non-major bleedings		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Diagnostic of a previously unknown malignancy		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Net clinical outcome (NCO)		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	O2 home treatment		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Pulmonary vasoactive drugs		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Development of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Hospitalization		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Length of stay in Hospital due to VTE		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Major adverse cardiac and cerebrovascular event (MACCE)		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Cardiovascular event		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary	Cerebrovascular event		Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)