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临床试验/NCT03317561
NCT03317561已完成不适用

Etiology of Myocardial Injury Following Non-cardiac Surgery - a Prospective Clinical Trial

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
450
试验地点
1
主要终点
Myocardial injury as seen by cMRI

研究概览

简要总结

It is estimated that > 200 million patients in the world undergo surgery each year of which approximately 10 million will suffer from a myocardial injury in the perioperative period. Mortality is high in patients with myocardial injury since it often goes undiagnosed and management is unclear. In contrast to myocardial infarction diagnosed in the emergency room (non-surgical patient) where treatment is well established today, patients suffering from a perioperative myocardial injury have a poorer outcome. Additionally, the patho-physiology of myocardial injury is unknown in the individual patient, non-invasive diagnostic tools are not widely available and treatment remains unknown.

Most cases of myocardial injury in Non-cardiac surgery (MINS) are seen within the first 48-72 h after surgery and a majority have no symptoms. Many patients developing MINS are < 65 years old and non-diabetics, an age group that usually does not have coronary artery disease. A elevated Troponin T (TnT) without symptoms or ECG changes, typically occurring in the perioperative period, is an independent predictor of 30-day mortality. Surgical trauma also causes an increase in several pro-inflammatory cytokines, which together with sympathetic over-activity and platelet activation, leads to a hyper-coagulant state, and in turn may cause coronary thrombosis. It is possible that some cases of MINS also result from oxygen supply-delivery mismatch. To our knowledge, no study has investigated the cause of MINS in patients presenting with increased TnT in the perioperative period. Our aim is therefore to investigate patients having MINS in order to better understand its aetiology and subsequently develop focused strategies to reduce risks.

详细描述

Introduction:

It is estimated that > 200 million patients in the world undergo surgery each year of which approximately 10 million would suffer from a myocardial injury in the perioperative period. Mortality is high in this group of patients since it often goes undiagnosed, the patho-physiology of myocardial injury is unclear, non-invasive diagnostic tools are not widely available and treatment is unknown.

Multiple studies have shown that > 10% of patients > 65 years and undergoing non-cardiac surgery have an increase in Troponin T (TnT). In the POISE study including 8331 patients, the authors found that 5.7% of the placebo group suffered from a myocardial injury within the 30-day postoperative period. In the recently published data from the VISION study including > 15,000 patients, the authors demonstrated that patients with peak perioperative TnT values of < 0.01, 0.02, 0.03-0.29 and > 0.30 ng/L had a 30-day mortality of 1%, 4%, 9.3% and 16.9% respectively. Furthermore, an elevated TnT without symptoms or ECG changes are an independent predictor of 30-day mortality. It is possible that some cases of myocardial injury in Non-cardiac surgery (MINS) result from oxygen supply-delivery mismatch due to severe perioperative hypotension, and possibly persistent tachycardia but coronary artery thrombosis cannot be excluded in these patients. It is well known that surgical trauma causes an increase in several pro-inflammatory cytokines which, together with sympathetic over-activity, leads to a hypercoagulable state due to platelet activation, and a predisposition to thrombosis. In one study, it was found that approximately 1/3 of the patients had evidence of intracoronary thrombosis at autopsy.

Myocardial infarction with non-obstructive coronary artery (MINCA) has recently received greater attention in the literature. The underlying patho-physiology responsible for MINCA revealed the presence of a typical myocardial infarct on cardiac magnetic resonance imaging in only 24% of patients, with myocarditis occurring in 33% and no significant abnormality in 26%. A rare cause of MINCA is Takotsubo cardiomyopathy, also called stress cardiomyopathy. Recently, coronary angiography using computerized tomographic angiography (CTA) has added a new dimension to the diagnostic armamentarium available to the clinician. Using advanced imaging techniques and low radiation, it is today possible to determine quite accurately coronary artery anatomy and thereby determine stenotic lesions in the coronary vasculature. Echocardiography can be easily performed by an experienced technician, the images stored digitally and evaluated subsequently by specialists. The availability of continuous perioperative monitoring of several hemodynamic indices as well as regular blood gas analysis, may enable determination of oxygen demand-supply mismatch.

Methods:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
45 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in the age group > 45 years
  • Non-cardiac, vascular surgery

排除标准

  • Patients with atrial fibrillation
  • Moderate-severe renal insufficiency (GFR < 50)
  • Allergy to iv contrast or drugs used for diagnostics will be excluded
  • Known lung embolism
  • Inability to comprehend the study or language barriers

结局指标

主要结局

Myocardial injury as seen by cMRI

时间窗: < 3 days after rise in Troponin T

Number of patients with a significant myocardial detected by cMRI in relation to the number that had an increase in TnT postoperatively

次要结局

  • Number of patients with significant ST-T segment changes (perioperative)(0 - 24 hours anesthesia induction)
  • Kidney injury(< 3 days after induction of anesthesia)
  • Mortality(Within 365 days)
  • Number of patients with significant Hypotension (perioperative)(24 hours after induction of anesthesia)
  • Protocolized echocardiography(< 48 hours after rise in Troponin T)

研究者

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

Anil Gupta

Associate Professor

Karolinska Institutet

研究点 (1)

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