GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- hemodynamic deterioration
研究概览
简要总结
Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism.
详细描述
Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism (APE).
In APE right ventricle failure developing due to ischemia and myocarditis is considered the primary cause of death, however, its pathomechanism has not been fully established yet. Growth differentiation factor 15 (GDF-15) is a chemokine secreted by activated macrophages in response to oxidative stress. It has now been shown that ischemic injury, mechanical stretch, and pro-inflammatory cytokines also stimulate the expression of GDF-15 in cardiac myocytes. The objective of this project is to describe the role of GDF-15 in the pathomechanism of acute right ventricle failure in the setting of acute pulmonary embolism and to verify the hypothesis that higher serum concentrations of GDF-15 are associated with more advanced right ventricle dysfunction and failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with APE hospitalized who give written consent.
排除标准
- •lack of informed consent
- •APE with symptoms lasting above 14 days before the admission
- •acute coronary syndrome, diagnosed pulmonary hypertension
- •severe valve disease
- •active malignancy
- •diagnosed mitochondrial diseases
- •chronic kidney disease at least stage 4 (KDIGO)
- •pregnancy.
结局指标
主要结局
hemodynamic deterioration
时间窗: assessed daily through study completion, average of 10 days
Hemodynamic deterioration defined according to ESC criteria as: change in blood pressure defined as: drop in systolic arterial blood pressure \< 90 mmHg or at least 40 mmHg, lasting ≤ than 15 minutes
次要结局
- Hemorrhagic complications(assessed daily through study completion, average of 10 days)
研究者
Marta Skowronska
Principal Investigator, Medical Doctor
Medical University of Warsaw