A Project to Improve the Diagnosis and Prognosis of Myocardial Injury Associated to Non Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Prevalence of myocardial injury after non cardiac surgery (MINS).
研究概览
简要总结
Major adverse cardiovascular events are the leading cause of perioperative morbimortality in non-cardiac surgery. Perioperative myocardial infarction is usually asymptomatic, with a mortality around 10-12%.
Myocardial Injury in Noncardiac Surgery (MINS), is defined as a myocardial injury that provokes a troponin increase due to myocardial ischemia. MINS is a predictor of morbimortality at short term and at long term.
The aim of the study is to improve the diagnosis of myocardial injury after non cardiac surgery in high-risk patients, improve its treatment in case of MINS and establish prevention strategies.
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
- •Patients of both genders over 45 years scheduled for non-urgent surgery with in-hospital stay of 24 hours minimum who require general and or regional anaesthesia (epidural or subarachnoidal) that have signed the inform consent who will be operated of:
- •High-risk surgery:
- •Open abdominal aortic aneurism repair
- •Major vascular surgery
- •Major amputations
- •Carotid endarterectomy
- •Duodeno-pancreatic surgery
- •Hepatic resection or resection of biliary duct
- •Esophagectomy
- •Suprarenal resection
- •Cystectomy
- •Pneumonectomy
- •Medium risk-surgery with cardiovascular risk factors (see below):
- •Intraperitoneal surgery (rectum, colon, small bowel, gastric surgery)
- •Peripherical angioplasty
- •Endovascular aneurism repair
- •Head and neck surgery
- •Major orthopedic surgery (hip, knee, column)
- •Major urological or gynecological surgery
- •Thoracic surgery (lobectomy or atypical pulmonary resections)
- •a) With 1 risk factor:
- •History of coronary artery disease
- •History of cerebrovascular disease (history of transient ischemic attack or stroke)
- •History of congestive heart failure
- •History of vascular disease
- •b) With 2 risk factors:
- •Diabetes mellitus with medical treatment
- •Renal disease (FGE < 45 ml•min-1•1.73m2 )
- •Functional capacity < 4METs
- •Intraoperative blood loss >600ml
排除标准
- •Patients without consent information
- •Patients non included in the inclusion criteria
研究组 & 干预措施
Non cardiac surgery
Determine perioperative troponin to diagnose perioperative MINS. In case of MINS acetylsalicylic acid and statins will be started if no contraindication. We will follow-up these patients for a year (including cardiologic evaluation after discharge)
干预措施: Troponin (Diagnostic Test)
Non cardiac surgery
Determine perioperative troponin to diagnose perioperative MINS. In case of MINS acetylsalicylic acid and statins will be started if no contraindication. We will follow-up these patients for a year (including cardiologic evaluation after discharge)
干预措施: Acetylsalicylic acid (Drug)
Non cardiac surgery
Determine perioperative troponin to diagnose perioperative MINS. In case of MINS acetylsalicylic acid and statins will be started if no contraindication. We will follow-up these patients for a year (including cardiologic evaluation after discharge)
干预措施: Statin (Drug)
结局指标
主要结局
Prevalence of myocardial injury after non cardiac surgery (MINS).
时间窗: From the day of surgery until the third postoperative day
The aim of the study is to know the prevalence of myocardial injury after non cardiac surgery in high-risk surgical patients. The investigators will perform seriated troponin on the first 3 postoperative days, if troponin value are 30ng/L or more, the investigators will evaluate if troponin increase is due to cardiac or non-cardiac etiology (patients with TEP or sepsis will be excluded). Once the non-cardiac etiology is ruled out, it will be diagnosed of MINS
次要结局
- Percentage of MINS which corresponds to myocardial infarction(From the day of surgery until the third postoperative day)
- Morbimortality in high-risk surgery patients until hospital discharge(From the day of surgery until hospital discharge or until 30 days after surgery in case the patient still hospitalized)
- Morbimortality in high-risk surgery patients 30 days after surgery(From the day of surgery until 30 days after surgery)
- Morbimortality in high-risk surgery patients 6 months after surgery(From the day of surgery until 6 months after surgery)
- Compare the prognosis of patients with MINS versus patients who present a myocardial infarction versus who presented non of them.(From the day of surgery until 1 year after surgery)
- Long term morbimortality in high-risk surgery patients(From the day of surgery until 1 year after surgery)
研究者
Sandra Beltran
Anesthesiologyst deputy, MD.
Parc de Salut Mar