VTEval Project - Three Observational, Prospective Cohort Studies Including Biobanking to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in Venous Thromboembolism
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Venous Thromboembolism (VTE)
- 发起方
- Johannes Gutenberg University Mainz
- 入组人数
- 2000
- 试验地点
- 1
- 主要终点
- Mortality
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
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.
研究者
Philipp Wild, MD, MSc
Univ.-Prof. Dr. med. Philipp Wild, MSc
Johannes Gutenberg University Mainz
入排标准
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Mortality
时间窗: Baseline
Overall mortality, consisting of: * PE-related death * All other causes of death
Symptomatic venous thromboembolism
时间窗: 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
次要结局
- Length of hospitalization(Baseline)
- Respiratory dysfunction(Assessment at month 3, 6 and 12; year 2-6 (Active follow-up))
- Pulmonary vasoactive drugs(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))
- Diagnostic of a previously unknown malignancy(Assessment at month 3, 6 and 12; year 2-6 (Active follow-up))
- Implantation of vena cava filter(Baseline)
- 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))
- Hemodynamic instability(Baseline)
- 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)
- 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))