Perioperative Major Adverse Cardiac Events in high risk patients undergoing major non cardiac surgeries: how accurately does pro-BNP and cardiac Troponin T predict the occurrence of major adverse cardiac events?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The primary outcome of our study is to determine the incidence of perioperative Major Adverse Cardiac Events in cardiac patients undergoing non cardiac surgery and all cause 30 day and 1 year mortality rate in these patients.
研究概览
简要总结
Cardiovascular complications in the perioperative period are one of the most common events leading to increased morbidity and mortality. Major adverse cardiac events include all-cause mortality or re-hospitalization for a cardiovascular-related illness. Recently perioperative cardiac troponin I(cTnI) and NT pro BNP measurements have been used for predicting the incidence of major adverse cardiac events after emergent non cardiac surgery. The present study was planned where serial levels of NT pro BNP and cardiac Troponin T will be measured at three intervals ( preoperative, immediately postoperative and on day 3 of surgery). The diagnostic senstivity of each of these values for MACE would be assessed individually. Also the incidence of 30 day and 1 year mortality rate would be assessed in these patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with prior history of coronary artery disease will be defined as having any one of the following: i)Definite CAD as indicated by a previous history of MI, typical angina or ECG changes suggestive of previous MI without a documented history of MI ii)Patient who underwent coronary artery reperfusion therapy including previous fibrinolytic therapy, percutaneous coronary intervention and coronary angioplasty.
- •Patient at risk of coronary artery disease will be defined as those with age 45 yr or older and had at least one of the following major cardiac risk factors34: 1) Diabetes mellitus 2) Peripheral artery disease (i.e. intermittent claudication or history of vascular surgery except arteriovenous shunt and vein-stripping procedures) 3) History of hospitalization for congestive heart failure 4) Renal insufficiency (defined as preoperative creatinine >150 μmol litre−1) 5) History of cerebral vascular event 6) Aortic valve stenosis (defined as aortic valve area <1 cm2) 7) Atrial fibrillation 8) Moderate or poor left ventricular function (defined as left ventricular ejection fraction <55%).
排除标准
- •Patients will be excluded from study participation if they had no signed informed consent.
结局指标
主要结局
The primary outcome of our study is to determine the incidence of perioperative Major Adverse Cardiac Events in cardiac patients undergoing non cardiac surgery and all cause 30 day and 1 year mortality rate in these patients.
时间窗: 30 days and 1 year
次要结局
- The secondary outcome is to determine whether high sensitive cardiac troponin T or pro-BNP is more accurate in predicting Major Adverse cardiac Events.(At preoperative stage, 24 hours following surgery and 72 hours following surgery.)