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临床试验/NCT04077294
NCT04077294已完成不适用

Epidemiological Patterns, Management Strategies and Cost Analysis of Care for the Patient With Perioperative Myocardial Injury When BNP is Used as a Screening Tool for Non-Cardiac Surgery

University of Alberta1 个研究点 分布在 1 个国家目标入组 333 人开始时间: 2019年5月21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
333
试验地点
1
主要终点
Preoperative Brain natriuretic peptide (BNP) ≥ 92 ng/L

研究概览

简要总结

Recently, the use of preoperative BNP as a preoperative risk stratifcation tool was added to the Canadian Cardiovascular Society (CCS) guidelines (4) on perioperative cardiac risk assessment and management for patients who undergo noncardiac surgery, based on the prognostic value of preoperative BNP in indentifiy patients at significant risk of 30-day mortality, nonfatal myocardial infarction, or myocardial injury after noncardiac surgery (MINS). While the value of screening for high risk patients through the use of preoperative BNP been demonstrated, the management of postoperative ischemia is less clear. Therefore, this study aims to:

  1. Evaluation of the use of BNP as a preoperative screening biomarker; how often is it ordered in Anesthesia Preadmission Clinic and what is the incidence of a positive result (BNP ≥ 92 ng/L)
  2. Determine the incidence of myocardial injury after non-cardiac surgery (MINS) at 30 days and myocardial infarction at 1 year at a tertiary care center when BNP is used as a screening tool
  3. Record patterns of management of patients with MINS
  4. Determine the cost associated with the different patterns of management of MINS
  5. Comparison with a cohort group who qualified for BNP screening according to CCS guidelines but did not have it measured. The investigators will attempt to evaluate the cohort group for MINS at 30 days and myocardial infarction at 1 year.

详细描述

Major cardiac complications are responsible for at least a third of perioperative deaths and are associated with significant morbidity, prolonged hospitalization and increased costs. This number is expected to rise as more surgeries are undertaken in older and frailer patients. The term myocardial injury after noncardiac surgery (MINS) is used to describe all myocardial injury due to ischemia occurring in the first 30 days after surgery. MINS includes:

  1. myocardial infarction (cardiac troponin I ≥ 0.04 ug/L) with at least one of: symptoms of ischemia, new ST segment / T wave changes or new left bundle branch block, pathological Q waves, new loss of viable myocardium or regional wall motion abnormality on echocardiogram, intracoronary thrombus identified on angiogram.
  2. myocardial injury without MI (elevated troponin without the additional criteria needed to diagnose MI).

The Canadian Cardiovascular Society (CCS) has developed a set of guidelines to help stratify which patients are at higher risk for cardiac mortality. In the latest revision of these guidelines, preoperative B-type natriuretic peptide (BNP) has been identified as a powerful independent predictor of perioperative cardiovascular complications. BNP is a protein released from ventricular cardiomyocytes. It is released in limited amounts during physiological conditions but this is increased significantly in ventricular failure, inflammation, fibrosis, ischemia and hypoxia. Rodseth et al. conducted a systematic review of the prognostic value of preoperative BNP and postoperative BNP in noncardiac surgery and showed that elevated preoperative BNP (i.e. ≥ 92 ng/l) carries a significant risk of 30-day mortality or nonfatal MI (21.8%). This is a significantly lower BNP value compared to what is typically seen in congestive cardiac failure patients. This study has been used to support the most recent CCS guidelines which add preoperative BNP as an important preoperative cardiac risk stratification tool. According to the CCS guidelines, patients with an elevated preoperative BNP should have daily troponins measured for 48 - 72 hours after surgery.

Troponins are components of the myocardial cell involved in contractility, specific subtypes I and T are expressed almost exclusively in the heart. An elevated troponin reflects necrosis of myocardial cells and is extremely useful in the diagnosis of a myocardial infarction. Even a slight elevation in postoperative troponins (TnTi ≥ 0.03ng/ml) without ischemic clinical symptoms can lead to a higher mortality, nonfatal cardiac arrest, nonfatal congestive heart failure, and nonfatal stroke.

While the value of screening for high risk patients through the use of preoperative BNP been demonstrated, the management of postoperative ischemia is less clear. At present, CCS guidelines recommend optimizing aspirin and statin therapy in patients with MINS, but no clear strategy has been elucidated. Evidence to support the use of aspirin and statins comes from the POISE trial. The MANAGE trial recommends starting patients who are not at risk of bleeding on the oral anticoagulant dabigatran for two years. Patients with ST-elevation MI carry a high mortality risk without reperfusion therapy (percutaneous coronary intervention or coronary artery bypass graft) and a high risk of bleeding with it. Patients with non ST-elevation MI may also require revascularization and subsequent dual antiplatelet therapy. It is evident from this brief overview that management of MINS varies from the non-invasive (aspirin and statin administration) to the invasive (PCI or CABG) depending on the extent of myocardial injury, hemodynamic stability and risk of bleeding secondary to the primary surgical 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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients:
  • ≥ 65 years of age
  • ≥ 18 years of age with a revised cardiac risk index (RCRI) ≥ 1
  • between 45 and 64 years of age with significant cardiovascular disease
  • Elective non-cardiac surgery with an overnight hospital stay (minimum 1 day)

排除标准

  • Subjects < 18 years of age
  • Patient refusal to participate
  • Patients undergoing cardiac surgery
  • Patients undergoing day surgery (< 1day hospital admission)

结局指标

主要结局

Preoperative Brain natriuretic peptide (BNP) ≥ 92 ng/L

时间窗: From date of preoperative consultation up to the day of surgery, assessed up to 6 months.

Number of participants with preoperative BNP ≥ 92 ng/L

Myocardial injury at 30 days after surgery

时间窗: 30 days after surgery

Incidence of myocardial injury 30 days after surgery at risk in patients as determined by preoperative BNP measurement

Myocardial injury 1 year after surgery

时间窗: 1 year after surgery

Incidence of myocardial injury 1 year after surgery at risk in patients as determined by preoperative BNP measurement

Postoperative troponin I ≥ 0.04 ug / L

时间窗: From the end of the surgical procedure to 72 hours postoperatively

Incidence of myocardial injury in the early postoperative period after non-cardiac surgery (MINS)

次要结局

  • Observation of management patterns 30 days after surgery in patients with myocardial injury after non-cardiac surgery (MINS)(30 days after surgery)
  • Observation of management patterns 1 year after surgery in patients with myocardial injury after non-cardiac surgery (MINS)(1 year after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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