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

Recruiting

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

• Registration Number: NCT02156401
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2030-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Baseline	Overall mortality, consisting of: * PE-related death; * All other causes of death
Symptomatic venous thromboembolism	Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)	Composed by: * PE-related death; * Development or recurrence of nonfatal PE; * Development or recurrence of DVT

Secondary Outcome Measures

Name	Time	Method
Thrombolytic treatment	Baseline
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)
Implantation of vena cava filter	Baseline
Diagnostic of a previously unknown malignancy	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)
Length of hospitalization	Baseline
Respiratory dysfunction	Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Hemodynamic instability	Baseline	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
Recurrence of acute PE	Baseline
Cardiac dysfunction or heart failure	Baseline
Pneumonia	Baseline
Major bleeding	Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Surgery	Baseline
Pulmonary vasoactive drugs	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)
Hospitalization	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)
Use of mechanical ventilation	Baseline
Admission to Intensive Care Unit (ICU)	Baseline
Symptomatic and/or asymptomatic DVT	Baseline
Interventional treatment	Baseline
Overall mortality	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)
Development of pulmonary hypertension	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)
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)
Net clinical outcome (NCO)	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)
Cardiovascular event	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)

Trial Locations

Locations (1)

University Medical Center of the Johannes Gutenberg University Mainz; 🇩🇪 Mainz, Rhineland-Palatinate, Germany