Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02156401

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location status: Recruiting

Location contact

Philipp S Wild, MD, MSc

CONTACT

[email protected]

00496131177163

Philipp S Wild, MD, MSc

PRINCIPAL_INVESTIGATOR

Stavros Konstantinides, MD, FESC

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: Baseline

    Overall mortality, consisting of:

    • PE-related death
    • All other causes of death
  2. Symptomatic venous thromboembolism

    Time frame: 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 outcomes

  1. Hemodynamic instability

    Time frame: 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
  2. Use of mechanical ventilation

    Time frame: Baseline

  3. Admission to Intensive Care Unit (ICU)

    Time frame: Baseline

  4. Recurrence of acute PE

    Time frame: Baseline

  5. Cardiac dysfunction or heart failure

    Time frame: Baseline

  6. Pneumonia

    Time frame: Baseline

  7. Symptomatic and/or asymptomatic DVT

    Time frame: Baseline

  8. Major bleeding

    Time frame: Baseline

  9. Clinically relevant non-major bleedings

    Time frame: Baseline

  10. Diagnostic of a previously unknown malignancy

    Time frame: Baseline

  11. Length of hospitalization

    Time frame: Baseline

  12. Implantation of vena cava filter

    Time frame: Baseline

  13. Thrombolytic treatment

    Time frame: Baseline

  14. Interventional treatment

    Time frame: Baseline

  15. Surgery

    Time frame: Baseline

  16. Overall mortality

    Time frame: Assessment at month 3/6 and 12; year 2-6 (Active follow-up)

  17. PE-related death

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

  18. Development or recurrence of clinical symptomatic PE/DVT

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

  19. Asymptomatic DVT

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

  20. Chronic venous insufficiency (CVI)

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

  21. Post-thrombotic Syndrome (PTS)

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

  22. Development of cardiac dysfunction or heart failure

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

  23. Development of pulmonary hypertension

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

  24. Respiratory dysfunction

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

  25. Major bleeding

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

  26. Clinically relevant non-major bleedings

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

  27. Diagnostic of a previously unknown malignancy

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

  28. Net clinical outcome (NCO)

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

  29. O2 home treatment

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

  30. Pulmonary vasoactive drugs

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

  31. Development of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

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

  32. Hospitalization

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

  33. Length of stay in Hospital due to VTE

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

  34. Major adverse cardiac and cerebrovascular event (MACCE)

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

  35. Cardiovascular event

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

  36. Cerebrovascular event

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

Study contacts

Contact information is provided by the study sponsor or research team.

Philipp S Wild, MD, MSc

CONTACT

[email protected]

0049 6131 17 7163

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • Bayer
  • Eurofins
  • Hochschule Fresenius
  • Maastricht University
  • Siemens Corporation, Corporate Technology
  • University of Bonn

Registry information

Official study title

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

Acronym: VTEval

Important dates

Study start
2013
Primary completion
2030
Study completion
2030
First posted
Jun 5, 2014
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.