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临床试验/NCT07094321
NCT07094321进行中(未招募)不适用

Predicting Postoperative Myocardial Injury: A Retrospective Cohort Study Comparing Absolute Versus Relative Definitions of Intraoperative Hypotension

China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
8,000
试验地点
1
主要终点
occurrence of postoperative myocardial injury

研究概览

简要总结

The investigators are conducting an important study aimed at better understanding and predicting a potential complication after non-cardiac surgery: myocardial injury. This research is crucial for enhancing surgical safety and improving patient outcomes.

Simply put, postoperative myocardial injury (PMI) means that heart muscle cells are damaged after non-cardiac surgery. While it might not cause obvious chest pain like a heart attack, it can show up as abnormalities on an electrocardiogram (ECG) or in blood tests (like elevated troponin levels). This type of injury is a significant factor contributing to postoperative complications and even mortality.

During surgery, hypotension-or low blood pressure-is a common occurrence. The investigators know that maintaining adequate blood pressure is essential for the heart to receive a sufficient blood supply. If blood pressure drops too low, the heart's blood supply can be reduced, potentially leading to oxygen deprivation and damage to heart muscle cells.

While it's widely accepted that low blood pressure is linked to myocardial injury, precisely defining "low blood pressure" during surgery has been a persistent challenge.

  • Historically, the investigators have focused on the "absolute value" of blood pressure, such as a fixed mean arterial pressure (MAP) threshold (e.g., below 65 mmHg). Many studies have indeed shown that MAP below 65 mmHg, especially for extended periods, increases the risk of PMI.
  • However, recent research is starting to challenge this perspective. Some studies have found that even maintaining a relatively higher blood pressure during surgery (e.g., MAP above 75 mmHg) didn't significantly reduce the incidence of PMI. This suggests that simply looking at a fixed blood pressure number might not tell the whole story.

Our preliminary research uncovered an intriguing finding: even if a patient's absolute blood pressure value during surgery seemed acceptable (e.g., above 60 mmHg), their risk of postoperative myocardial injury significantly increased if that pressure had dropped by more than 40% from their individual "normal" pre-operative blood pressure. Based on this discovery, our study proposes a novel hypothesis: the percentage drop in MAP from an individual's baseline might be more strongly correlated with postoperative myocardial injury and a better predictor of risk than the absolute MAP value.

The investigators will be reviewing patient data from non-cardiac surgeries performed at China-Japan Friendship Hospital between 2020 and 2025. The investigators will meticulously analyze these patients' intraoperative blood pressure changes (considering both absolute values and the percentage change from their pre-operative baseline) and compare these findings with whether they developed myocardial injury after surgery.

Our study's goal is to determine which definition of low blood pressure (absolute value or percentage drop from baseline) is more closely related to postoperative myocardial injury.

The investigators will collect detailed patient information, including demographics, past medical history, pre- and post-operative test results, intraoperative vital signs (blood pressure, heart rate, oxygen saturation, etc., recorded every 15 seconds), and intraoperative medications. All data will undergo rigorous statistical analysis to ensure the scientific validity and reliability of our findings.

The results of this study will help us more accurately identify patients at high risk for postoperative myocardial injury. If our hypothesis is confirmed, it means that during surgery, doctors, in addition to monitoring absolute blood pressure values, will pay closer attention to the degree of blood pressure drop relative to a patient's own normal baseline. This will help to:

  • Improve understanding of individual patient differences: Recognizing that what's "normal" for one patient might be too low for another.
  • Enable more precise adjustments in anesthesia and surgical management: Allowing for timely interventions to maintain optimal heart muscle perfusion, thereby reducing the incidence of postoperative myocardial injury.
  • Ultimately, enhance patient safety during surgery and improve their recovery and long-term outcomes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • •Patients who underwent elective non-cardiac, non-emergency surgery with general anesthesia at China-Japan Friendship Hospital between 2020 and
  • •Surgical duration greater than 1 hour.
  • •Received at least one cardiac injury marker test (e.g., troponin) within 7 days post-surgery.
  • •Patients with American Society of Anesthesiologists (ASA) physical status classification of I-III.

排除标准

  • •Patients younger than 12 years old.
  • •Patients undergoing organ transplant surgery.
  • •Patients with more than 10 consecutive minutes of invalid or missing intraoperative vital signs data.
  • •Patients with critical missing data that cannot be reasonably imputed (general data completeness issues).

结局指标

主要结局

occurrence of postoperative myocardial injury

时间窗: Within 7 days following non-cardiac surgery

PMI is defined as an elevation of cardiac troponin (e.g., high-sensitivity troponin I or T) levels above the 99th percentile upper reference limit (URL) of the local institutional laboratory within 7 days following non-cardiac surgery. This outcome will be assessed based on routine postoperative cardiac biomarker measurements performed as part of standard clinical care. PMI serves as a critical indicator for evaluating cardiac damage post-surgery and is closely associated with adverse patient outcomes and prognosis.

次要结局

未报告次要终点

研究者

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kan Wang

Dr

China-Japan Friendship Hospital

研究点 (1)

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