Perioperative Myocardial Ischemia: Implementation of Troponin Monitoring, Economic Analysis and Further Insights Into Pathophysiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,510
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
Background: Despite preoperative screening, technical improvements and increased patient monitoring, perioperative myocardial infarction (PMI) remains the first cause of morbidity and mortality within 30 days after surgery. Moreover, the available evidence indicates worrying rise of risk in postoperative patients with only elevated troponins reflecting cardiac injury, but without a conventional clinical diagnosis of myocardial infarction according to current definition. Worldwide, annually approximately 300 million adults undergo major non cardiac surgery and 10 million of them are estimated to suffer a myocardial injury after non-cardiac surgery (MINS), defined as a prognostically relevant increase of a troponin T peak of 0.03 ng/ml or greater. Many of the patients with MINS does not fulfill the universal definition of myocardial infarction, rarely experience ischemic symptoms and their prognosis is very poor (1 out of 10 die at 30 days).Troponin levels needed to be monitored in order to MINS diagnose and high sensitive cardiac troponin T assays are currently the most frequently used.
Methods: Patients with high cardiovascular risk undergoing major non-cardiac surgery will be selected from the daily surgical program during a two years period Three determinations of hs-cTnT for each patient will be obtained. The proportion of patients with MINS and pre- and post-operative thresholds of hs-cTnT that would be prognostically relevant will be determined. The cost-effectiveness analysis of hs-cTnT monitoring compared with usual care will be undertaken. Finally using computed tomography angiography (CTA) and cardiac magnetic resonance imaging (MRI) pathophysiology of MINS will be determined, whether is due to plaque rupture, supply-demand mismatch, non-ischemic cardiac cause or non-cardiac cause.
Discussion: The study will evaluate the feasibility and impact of implementing the hs-cTnT monitoring program in the Hospital de la Santa Creu i Sant Pau of Barcelona, as well as its cost-effectiveness. Moreover, this is the first study which will determine pre and postoperative thresholds of hs-cTnT and with minimally invasive diagnostic tools will evaluate potential mechanisms involved in perioperative ischemic events.
详细描述
The study consists of four sub studies
- Troponin monitoring implementation - Sub study A
- Preoperative and postoperative hs-cTnT threshold - Sub study B
- Economic analysis - Sub study C
- Advanced cardiac imaging case-control study - Sub study D
Study A:To implement and evaluate a Troponin T monitoring program in patients with high cardiovascular risk undergoing major non-cardiac surgery, the investigators will include prospectively patients with one or more of the following inclusion criteria (intervention cohort). Age, sex, type of surgery, revised cardiac risk index, history of coronary artery disease, history of cardiac arrest, history of congestive heart failure, history of peripheral vascular disease, history of stroke, history of a transient ischemic attack, chronic renal failure, history of deep venous thrombosis or pulmonary embolism, diabetes, hypertension, current atrial fibrillation, chronic obstructive pulmonary disease, type of treatment (statins and antithrombotic treatments) will be collected.
The investigators will obtain three determinations of Roche high-sensitive troponin T (99th percentile (14 ng/L) for each patient: preoperative (during the preoperative visit or just before surgery), 48h, and 72h after surgery. If a rise and/or fall of hs-cTnT with at least one value above the 99th percentile upper reference is detected, a clinical evaluation and a 12-lead ECG will be performed. If no ECG changes, ischemic symptoms, or pulmonary edema to fulfill the diagnostic for PMI the patients will undergo an echocardiographic study.
Study B: All patients included in study A (see above) will included. The investigators will measure high sensitivity cardiac troponin T using a Roche Elecsys 2010 analyzer (limit of detection 5.0 ng/L, 99th percentile 14 ng/L, a 10% coefficient of variation at 13 ng/L) at three predefined time points: preoperatively (during the preoperative visit or just before surgery), at 48h and 72h after surgery. The main outcome will be 30 day and 1 year mortality.
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 98 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
All cause mortality
时间窗: 1 month and 1 year after surgery
Occurence of all cause mortality
次要结局
- Major adverse cardiac events (MACE)(1 month and 1 year after surgery)
- Medication modifications(1 month and 1 year after surgery)