NCT05812248招募中不适用
Prediction of Vascular Events After Major Non-Cardiac Surgery : an Observational Prospective Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Number of patients with major adverse cardiac event
研究概览
简要总结
This observational study includes patients at medium-to-high cardiovascular risks undergoing major noncardiac surgery, measures their baseline demographic and clinical characteristics, preoperative cardiac biomarkers and intraoperative surgery/anesthesia related data, and screens them for the occurrence of myocardial injury and major adverse cardiac events after surgery. The primary aim is to develop and validate a pre- and an immediate postoperative prediction model for occurrence of major adverse cardiac events.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 45 years;
- •Undergoing major noncardiac surgery (expected procedure duration ≥2 h, expected length of postoperative stay ≥2 d);
- •History of at least one cardiovascular disease (i.e., coronary artery disease, stroke, congestive heart failure, or peripheral arterial disease) or with at least two cardiovascular risk factors (i.e., hypertension, diabetes, chronic kidney disease, smoking in the past ≥2 years, ≥65 years of age, hypercholesterolemia, history of TIA, high-risk surgery (intrathoracic, intraperitoneal, or major vascular)).
排除标准
- •History of acute cardiovascular events within 30 days prior to surgery;
- •American Society of Anesthesiologists (ASA) physical status of 5 or greater;
- •Previously enrolled in this study;
- •Unable to understand or to sign informed consent.
结局指标
主要结局
Number of patients with major adverse cardiac event
时间窗: Within 30 days after the index surgery
A composite outcome that includes cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation.
次要结局
- Number of patients with myocardial injury after noncardiac suregry (MINS)(Within 30 days after the index surgery)
研究者
研究点 (1)
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