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临床试验/NCT02150486
NCT02150486已完成不适用

Postoperative Myocardial Injury and Non-cardiac Complications After Major Abdominal Surgery in Patients at Risk for Coronary Artery Disease

St. Antonius Hospital1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
210
试验地点
1
主要终点
Postoperative myocardial injury

研究概览

简要总结

To determine whether perioperative myocardial injury is associated with adverse outcome in patients scheduled for major abdominal surgery.

详细描述

Study design

The MICOLON study is a prospective, single-centre, observational cohort study on the association between 5th generation high sensitive cardiac troponin T levels and non-cardiac outcome after major abdominal surgery in patients at risk for coronary artery disease.

Patient eligibility

Patients are eligible to enter the study if they are scheduled to undergo elective major abdominal surgery with an expected postoperative mortality rate >3%, are aged 45 years or older and have at least one of the following major cardiac risk factors: diabetes mellitus, peripheral artery disease (i.e. intermittent claudication or history of vascular surgery except arteriovenous shunt and vein stripping procedures), history of hospitalization for congestive heart failure, history of myocardial infarction, stable angina pectoris, history of coronary artery bypass grafting or percutaneous coronary angioplasty, renal insufficiency (defined as preoperative creatinine >150 μmol/L), history of cerebral vascular event, aortic valve stenosis (defined as aortic valve area <1 cm2), atrial fibrillation, moderate or poor left ventricular function (defined as left ventricular ejection fraction <55%), or two of the following minor risk factors for coronary artery disease: age >70 years, hypertension, hypercholesterolemia, history of transient ischemic attack, chronic obstructive pulmonary disease, smoking or low functional capacity (capable of physical activity of 4 metabolic equivalents or less). Patients are excluded from study participation if they have no signed informed consent.

Study procedure

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

入选标准

  • Patients > 45 years of age with 1 or more major cardiovascular risk factors: Congestive heart failure, peripheral artery disease (intermittent claudication, history of vascular surgery etc), diabetes mellitus type I or II, coronary artery disease (history of myocardial infarction, stable angina pectoris, history of ischemia or coronary artery disease on cardiac tests (electrocardiogram, scintigraphy, echocardiogram, coronary angiogram etc), cerebrovascular accident, renal insufficiency (creatinine > 150umol/l), aortic valve stenosis (valve area < 1 cm2) OR 2 or more minor cardiovascular risk factors: Age > 70, hypertension, high cholesterol, low functional capacity (4 metabolic equivalents or less), transient ischemic attack, chronic obstructive pulmonary disease AND undergoing abdominal surgery with an expected 30-day mortality rate > 2-3%: colorectal, gastric, pancreatic and liver surgery.

排除标准

  • Age < 45 years of age, not scheduled for higher risk abdominal surgery, low cardiovascular risk profile.

结局指标

主要结局

Postoperative myocardial injury

时间窗: 7 days

high sensitive troponin elevation at day 1, 3 or 7 after surgery

次要结局

  • Complication(30-days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. P. Noordzij

MD PhD

St. Antonius Hospital

研究点 (1)

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