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

Johannes Gutenberg University (JGU)

Status: Enrolling

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02156401

UMCM-2013EPI02

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,000 participants in 3 patient groups

Cohort 1: Suspect of Pulmonary Embolism (PE)

Cohort 2: Suspect of Deep Vein Thrombosis (DVT)

Cohort 3: Incidental Venous Thromboembolism (VTE)