PeriOperative Medicine - Metabolic Inflexibility as a Mechanism for Myocardial Injury After Non-Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Development of Myocardial Injury after Non-Cardiac Surgery
研究概览
简要总结
The goal of this observational study is to learn whether metabolic inflexibility, which means reduced ability of the body to switch between using fats and sugars for energy, is associated with myocardial injury after non-cardiac surgery (MINS) in adults undergoing major elective abdominal cancer surgery.
The main question it aims to answer is:
Does pre-operative metabolic inflexibility predict myocardial injury after non-cardiac surgery (MINS) within the first 72 hours after surgery?
Participants will continue with their usual surgical care and pre-planned CPET (which can measure metabolic flexibility). As part of the study, participants will:
- Have additional blood samples taken before and after surgery
- Have an echocardiogram and, where possible, muscle ultrasound
- Wear a wrist-worn activity monitor before surgery
- Have routine clinical and surgical information collected from their medical records
- Receive a follow-up phone call around 90 days after surgery
详细描述
The POM-MIMIC study (PeriOperative Medicine - Metabolic Inflexibility as a mechanism for Myocardial Injury after Non-Cardiac Surgery) is a prospective, observational cohort study designed to improve perioperative risk stratification for myocardial injury after non-cardiac surgery (MINS). MINS affects up to 25% of patients undergoing major surgery and significantly increases long and short term mortality (1). Despite its clinical importance, the ability to predict MINS remains limited.
This study aims to evaluate if perioperative metabolic inflexibility, (the impaired ability of cells to adapt fuel usage to demand), is a driver of MINS. The study hypothesises that systemic metabolic dysfunction creates a state of cardiac vulnerability, priming the heart for injury when exposed to the multi-faceted immune/inflammatory and haemodynamic stressors of surgery and anaesthesia.
This study involves a prospective, multicentre observational cohort study of patients undergoing major abdominal cancer surgery. The study investigators will employ a deep, multi-modal phenotyping strategy to characterise each patient's intrinsic "metabolic resilience phenotype", with the goal of describing novel endotypes of MINS. The investigators propose that the endotypes of MINS are:
Immune mediated / inflammatory endotype: Driven by pre-existing inflammation and perioperative immune dysregulation
Metabolic / proteomic endotype: Driven by metabolic inflexibility and may involve direct metabolic injury to cardiomyocytes, lipotoxicity, oxidative stress, and unique troponin fragment signatures
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
- 否
入选标准
- •Adults aged 18 or over
- •Scheduled for major elective abdominal cancer surgery with planned overnight admission
- •Scheduled for pre-operative CPET
- •Able to provide written informed consent
排除标准
- •Less than 18 years old
- •Emergency surgery
- •Unable or unwilling to undergo CPET
- •Pregnancy
- •Active sepsis
- •End-stage organ failure (e.g. on dialysis)
- •Participants without the mental capacity to consent
- •Diagnosis of Type 1 Myocardial Infarction meeting the 4th Universal Definition criteria during the immediate pre-operative period. (Note: Added based on MINS definition context)
研究组 & 干预措施
Major Abdominal Cancer Surgery Cohort
Adults aged 18 years and over who are scheduled to undergo major elective abdominal cancer surgery and are already referred for routine pre-operative cardiopulmonary exercise testing (CPET). This is an observational cohort study; no study-specific treatment or intervention will be assigned. Participants will continue with their usual surgical and perioperative care. The study will collect additional blood samples, imaging assessments, CPET-derived metabolic data, wearable activity data, and routine clinical information to evaluate whether pre-operative metabolic inflexibility is associated with myocardial injury after non-cardiac surgery.
干预措施: Pre-operative Metabolic Inflexibility (Other)
结局指标
主要结局
Development of Myocardial Injury after Non-Cardiac Surgery
时间窗: From surgery to 72 hours post surgery
The primary outcome is the number of participants who develop myocardial injury after non-cardiac surgery (MINS) within 72 hours after surgery. MINS means evidence of heart muscle injury after an operation that is not heart surgery. It will be assessed using blood tests for high-sensitivity cardiac troponin I, a protein that is released into the blood when the heart muscle is injured. Blood samples will be taken on postoperative days 1, 2, and 3. Participants will be classified as having MINS if their postoperative troponin result is above the study-defined threshold for myocardial injury and the injury is judged to be related to the perioperative period rather than another clear non-surgical cause.
次要结局
- Clavien-Dindo Complication Grade(From surgery to 30 days after surgery)
- Post-Operative Morbidity Survey (POMS)(Postoperative day 7)
- Length of Hospital Stay(From surgery up to hospital discharge, an expected average of 7 days after surgery)
- Days Alive and Out of Hospital at 90 Days(From surgery to 90 days after surgery)