Continuous Monitoring of Vital Signs for Improved Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery in High Risk Patients: PMI-VITAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 875
- 试验地点
- 1
- 主要终点
- Perioperative myocardial infarction/injury (PMI)
研究概览
简要总结
The goal of this observational prospective cohort study is to learn about the pathophysiology of perioperative myocardial infarction/injury in high-risk patients undergoing major non-cardiac surgery.
Participants will:
- Wear wearable device (Basler Band) for up to seven days after the operation or until hospital discharge
- Provide three blood samples. A venous specimen of blood (25 mL) will be collected preoperatively and on postoperative days 1 and 2.
- Be contacted to answer a questionnaire one year after the surgery.
详细描述
Background:
With over 300 million surgical procedures performed annually, surgery and anaesthesia provide major medical value to patients, especially in resource-rich countries like Switzerland with about 900.000 procedures done per year. Demand for surgery is expected to further increase in the coming years due to the aging of the population and the availability of novel less invasive surgical procedures making even elderly patients with extensive comorbidities possibly eligible for surgery.
Perioperative myocardial infarction/injury (PMI) has been identified as a major contributor to perioperative mortality. First studies estimated that PMI is a major contributor to 34-42% of all deaths following noncardiac surgery within 30 days. Recent research by several groups including ours has highlighted that PMI is not a homogenous disease entity, but seems to comprise several underlying pathophysiologies. These include type I myocardial infarction due to atherothrombosis, type II myocardial infarction due to myocardial oxygen supply-demand mismatch, tachyarrhythmias, acute heart failure, and PMI due to primarily extra-cardiac disorders such as severe sepsis, stroke, or pulmonary embolism. Unfortunately, the underlying pathophysiology of PMI remains unknown in many patients. This is among other things due to incomplete recording and documentation of patient vital signs including heart rate, blood pressure, and oxygen saturation e.g. in the postoperative period once patients leave the operating room. Identifying the underlying trigger of PMI is a prerequisite for causal therapy and prevention.
Objectives:
- To continuously document and quantify the frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxemia, that are not recorded and documented using the current clinical monitoring standards, but detected using continuous monitoring of vital signs using the wearable device (Basler Band) throughout the whole perioperative period.
- To validate the diagnosis of PMI within a screening program in high-risk patients undergoing major noncardiac surgery with other troponin assays.
- To evaluate the diagnostic and predictive utility of novel biochemical markers.
- To technically validate intraoperative haemodynamic measurements of wearable device by comparing them to routinely obtained intraoperative haemodynamics.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient eligible for routine PMI-screening
- •Patient requiring hospitalisation with ≥ 2 overnight stays after surgery
- •Age ≥ 40 years to ≤ 85 AND history of coronary artery disease (CAD), peripheral artery disease (PAD), cerebrovascular disease/stroke, insulin-dependent diabetes mellitus (IDDM), or chronic heart failure (CHF)
- •Elective surgery
- •Patients undergoing orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, urological or visceral surgery
- •Patient consent available
排除标准
- •Patient's refusal
- •Heart surgery, cardiac arrest, acute mycardial infarction (AMI), cardiac valve intervention, or cardiac catheter ablation within 14 days prior to surgery OR involvement of heart surgery at index surgery OR surgery planned on cardiopulmonary bypass
- •Patients undergoing plastic/reconstructive, ophthalmologic, dental, hand surgery, or ear-nose-and-throat surgery
- •Chronic renal failure on dialysis, unless undergoing renal transplant surgery
- •Moderate to severe dementia
- •Inclusion into study within the last year
结局指标
主要结局
Perioperative myocardial infarction/injury (PMI)
时间窗: 3 days after surgery
PMI is defined as an absolute increase in high-sensitivity cardiac troponin (hs-cTn) of the 99th percentile of healthy individuals for the respective assay above baseline cTn-value or between two postoperative values if the preoperative value was missing. PMI will be further classified as type I myocardial infarction, type II myocardial infarction, or myocardial injury due to non-cardiac causes. Two independent cardiologists or anaesthesiologists will adjudicate all PMI cases.
Comparison of the incidence and prognostic impact of PMI detected by using different troponin assays
时间窗: 3 days after surgery
Comparison of the incidence and prognostic impact of PMI detected by using different high-sensitivity cardiac troponin I (hs-cTnI) assays in parallel to the clinical PMI-screening using high-sensitivity cardiac troponin T (hs-cTnT) assays.
Major adverse cardiac and cerebral events (MACCE)
时间窗: 1 year
MACCE is defined as a composite of all-cause death, acute myocardial infarction, acute heart failure (requiring admission to a hospital or intra-hospital transfer to the internal medicine or intensive care unit), clinically relevant arrhythmias (cardiac arrest, sustained ventricular tachycardia, atrioventricular (AV)-block III, high rate atrial fibrillation/flutter requiring treatment, bradycardia requiring pacemaker, or rhythmogenic syncope) and stroke/transient ischaemic attack within one year.
Using biomarkers as tools for prediction of major cardiac complications in patients undergoing non-cardiac surgery
时间窗: 3 days after surgery
Evaluation of the incremental value of additional cardiovascular biomarkers and continuous vital sign monitoring in the prediction of PMI and other cardiac complications, as well as the prediction of death, and the understanding of the pathophysiology of PMI.
Postoperative atrial fibrillation (POAF)
时间窗: During surgery and up to 7 days after surgery or until hospital discharge.
POAF is defined as new-onset atrial fibrillation (AF) in the immediate postoperative period of duration/burden at least 30 minutes detected using continuous monitoring of vital signs using the wearable device (Basler Band), but not recorded and documented using the current clinical monitoring standards.
Documentation and quantification of the frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxaemia.
时间窗: During surgery and up to 7 days after surgery or until discharge.
Frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxaemia detected using continuous monitoring of vital signs using the "Basler Band" throughout the whole perioperative period, and use this information to characterise PMI. Major abnormalities will be defined as: hypotension (systolic blood pressure \<85 mmHg or more than 40 mmHg lower than at the initiation of analgosedation for \>10 minutes), hypertension (systolic blood pressure \>190 mmHg \>20 minutes), tachyarrhythmia (ventricular rate \>120 for \>20 minutes), bradycardia (asystole \>10 s or heart rate \<40/min for \>30 minutes), and/or hypoxaemia (pulse oximetry \<85% for \>20 minutes).
次要结局
- Number of patients with PMI with ischemic symptoms and signs detected in a screening program in high-risk patients undergoing major non-cardiac surgery(3 days after surgery)