MET: REevaluation for Perioperative cArdIac Risk (MET-REPAIR): a Prospective, Multi-centre Cohort Observational Study- Presepsin (sCD14-ST) for Perioperative Risk Prediction Nested Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,695
- 试验地点
- 1
- 主要终点
- Composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke
研究概览
简要总结
Multicentre international prospective cohort study designed to evaluate whether preoperative presepsin (sCD14-ST) is associated with the composite endpoint: all-cause mortality and major adverse cardiovascular or cerebrovascular events (MACCE) after elevated risk non-cardiac surgery. If so:
- What is the optimal cut-off for presepsin to predict the composite endpoint all-cause mortality and MACCE?
- Does the calculated optimal cut-off improve prediction of the composite endpoint all-cause mortality and MACCE when added to clinical data and established biomarkers?
详细描述
Major non-cardiac surgery is still associated with relevant cardiovascular mortality and morbidity. In Europe, in-hospital mortality exceeded 7% in patients with coronary artery disease and in those with congestive heart failure. Within 30 days of non-cardiac surgery procedures, 8% of patients will suffer a major cardiovascular event.
Immunological processes, increased recruitment and infiltration of innate and adaptive immune cells into atherosclerotic lesions, have been shown to drive perioperative atherosclerotic lesion progression and plaque destabilization and are thought to promote plaque rupture. When classical monocytes are activated to inflammatory non-classical monocytes, the membrane-bound cell surface protein CD14 is released into circulation. In plasma, soluble CD14 (sCD14) is cleaved by lysosomal proteases. The N-terminal 13kDa fragment constitutes sCD14 subtype (sCD14-ST), also called presepsin. Presepsin has been established as a marker for early identification of patients with systemic infections. Recently, presepsin has been proposed as a biomarker for preoperative risk prediction in cardiac surgery. Our preliminary results in a limited number of patients suggest that presepsin is associated with major adverse cardiovascular and cerebrovascular events after non-cardiac surgery as well with all-cause mortality. Presepsin might have a test characteristic superior to conventional risk assessment on the basis of the revised cardiac risk index (RCRI), high-sensitivity cardiac Troponin-T (hs-cTnT) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP).
Preoperative presepsin quantification might help to identify non-cardiac surgery patients prone to experience perioperative major adverse cardiovascular and cerebrovascular events.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke
时间窗: at discharge or at day 30 after surgery (whatever comes first)
Number of Patients with Composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke
次要结局
- All-cause mortality(30 days)
- Myocardial infarction(30 days)
- Non-fatal cardiac arrest(30 days)
- Congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care (≥24h)(30 days)
- Length of Hospital stay(within 30 days after surgery)
- Length of ICU stay(within 30 days after surgery)
- Myocardial injury after non-cardiac surgery (MINS)(within 30 days after surgery)
- Cardiovascular mortality(30 days)
- Complications ≥ 3 in Clavien Dindo Classification(within 30 days after surgery)
- Stroke(30 days)
- Composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke(30 days)
- In-hospital cardiovascular mortality(30 days)
研究者
Jan Larmann
Dr., PhD
University Hospital Heidelberg