Validation of the AUB-HAS2 Score in a Brazilian Population and Study of the Additional Impact of Biomarkers in Predicting Perioperative Risk
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS
研究概览
简要总结
ASPIRE is a prospective, multicenter, observational study that will assess the performance of AUB-HAS2 to predict the occurrence of major adverse cardiovascular events 30-days after a non-cardiac surgery and the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac procedures.
详细描述
Primary objectives:
Primary objective of the validation arm: to analyze the accuracy of the AUB-HAS2 index in predicting the occurrence of myocardial infarction, stroke and death within 30 days after non-cardiac surgeries.
Primary objective biomarker arm: to analyze the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac surgeries.
Secondary objectives:
To analyze the potentially preventable factors related to adverse outcomes after non-cardiac surgeries in order to offer subsidies for more assertive guidelines regarding the implementation of perioperative protection strategies. Compare the performance of these scores with others that have already been validated (ACP and Lee - see Annex A).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years, in the preoperative period of non-cardiac procedures, with expected hospitalization for at least 24 hours postoperatively.
排除标准
- •Refusal to sign the informed consent form.
结局指标
主要结局
RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS
时间窗: 30 days
COMPOSITE OF DEATH, MYOCARDIAL INFARCTION AND STROKE
次要结局
- RATE OF MYOCARDIAL INJURY(30 days)
研究者
Pedro Gabriel Melo de Barros e Silva
Director of Clinical Research
Hospital Samaritano Paulista