Clinical trial NCT02156401: VTEval Project - Prospective Cohort Studies to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in VTE
Official title: VTEval Project - Three Observational, Prospective Cohort Studies Including Biobanking to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Thromboembolism (VTE)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Keywords: Venous thromboembolism
Deep vein thrombosis
Pulmonary embolism
Cohort study/epidemiology
Outcome
Prognosis
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Maastricht University
name: Hochschule Fresenius
name: University of Bonn
name: Siemens Corporation, Corporate Technology
name: Bayer
name: Eurofins
First posted: 2014-06-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals either with clinically suspected or incident diagnosis of VTE

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.


Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: Baseline
measure: Symptomatic venous thromboembolism
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Secondary outcomes:
measure: Hemodynamic instability
timeFrame: Baseline
measure: Use of mechanical ventilation
timeFrame: Baseline
measure: Admission to Intensive Care Unit (ICU)
timeFrame: Baseline
measure: Recurrence of acute PE
timeFrame: Baseline
measure: Cardiac dysfunction or heart failure
timeFrame: Baseline
measure: Pneumonia
timeFrame: Baseline
measure: Symptomatic and/or asymptomatic DVT
timeFrame: Baseline
measure: Major bleeding
timeFrame: Baseline
measure: Clinically relevant non-major bleedings
timeFrame: Baseline
measure: Diagnostic of a previously unknown malignancy
timeFrame: Baseline
measure: Length of hospitalization
timeFrame: Baseline
measure: Implantation of vena cava filter
timeFrame: Baseline
measure: Thrombolytic treatment
timeFrame: Baseline
measure: Interventional treatment
timeFrame: Baseline
measure: Surgery
timeFrame: Baseline
measure: Overall mortality
timeFrame: Assessment at month 3/6 and 12; year 2-6 (Active follow-up)
measure: PE-related death
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Development or recurrence of clinical symptomatic PE/DVT
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Asymptomatic DVT
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Chronic venous insufficiency (CVI)
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Post-thrombotic Syndrome (PTS)
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Development of cardiac dysfunction or heart failure
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Development of pulmonary hypertension
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Respiratory dysfunction
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Major bleeding
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Clinically relevant non-major bleedings
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Diagnostic of a previously unknown malignancy
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Net clinical outcome (NCO)
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: O2 home treatment
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Pulmonary vasoactive drugs
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Development of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Hospitalization
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Length of stay in Hospital due to VTE
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Major adverse cardiac and cerebrovascular event (MACCE)
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Cardiovascular event
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
measure: Cerebrovascular event
timeFrame: Assessment at month 3, 6 and 12; year 2-6 (Active follow-up)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg University Mainz
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center of Johannes Gutenberg University Mainz, Germany
name: Philipp S Wild, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.