跳至主要内容
临床试验/NCT07709377
NCT07709377进行中(未招募)不适用

Artificial Intelligence-Based Analysis of Risk Factors and Risk Prediction Model for Major Adverse Cardiovascular Events Following Hip Fracture Surgery in the Elderly

Beijing Anzhen Hospital2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年7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
600
试验地点
2
主要终点
Number of Participants With In-Hospital Postoperative Major Adverse Cardiac Events

研究概览

简要总结

This is a multicenter ambispective observational cohort study led by Beijing Anzhen Hospital, Capital Medical University, with China-Japan Friendship Hospital serving as the external validation center.

Major adverse cardiovascular events (MACE) occurring after surgery are common complications among older adults undergoing hip fracture surgery and are associated with poor long-term outcomes, including increased one-year mortality. Previous studies have not systematically evaluated perioperative risk factors or developed prediction models specifically for this population. In addition, conventional statistical approaches may have limited ability to account for complex interactions and nonlinear associations among multiple perioperative variables. Therefore, this study aims to identify risk factors for postoperative MACE and to develop and externally validate a machine learning-based prediction model.

Patients aged 60 years or older who undergo surgical treatment for hip fracture will be included. The derivation cohort, established at Beijing Anzhen Hospital, will be used for model development and internal validation, whereas the independent external validation cohort, established at China-Japan Friendship Hospital, will be used to evaluate the generalizability and predictive performance of the developed model. The study will adopt a bidirectional cohort design: one portion of the study population will be identified retrospectively from electronic medical records, and the remaining participants will be consecutively enrolled prospectively following ethics committee approval. Postoperative outcomes will be ascertained from the end of surgery until the earliest occurrence of hospital discharge, death, or postoperative day 30.

Standardized, de-identified data will be collected, including demographic characteristics, comorbidities, laboratory findings, surgical and anesthetic information, perioperative medications, and postoperative MACE outcomes. No study-specific intervention will be assigned, and all patients will receive routine clinical care. Data will be managed in accordance with institutional privacy policies and applicable data protection requirements.

Candidate predictors will be evaluated using univariable analyses, least absolute shrinkage and selection operator regression, and random forest-based feature selection. Prediction models, including logistic regression, XGBoost, and LightGBM, will be developed in the derivation cohort. Internal validation will be performed using resampling methods, and external validation will be conducted using data from the independent validation center. Model performance will be assessed in terms of discrimination, calibration, and clinical utility using the area under the receiver operating characteristic curve, calibration plots, and other appropriate performance measures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥60 years;
  • Diagnosis of femoral neck fracture or intertrochanteric fracture, including subtrochanteric fracture;
  • Undergoing surgical treatment.

排除标准

  • Pathological fracture;
  • High-energy trauma or multiple injuries;
  • Incomplete relevant clinical data;
  • Failure to provide written informed consent (prospective cohort only).

结局指标

主要结局

Number of Participants With In-Hospital Postoperative Major Adverse Cardiac Events

时间窗: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.

Major adverse cardiac events were defined as a composite of cardiovascular death, nonfatal myocardial infarction, arrhythmia, and heart failure occurring during the postoperative hospital stay. Each participant was counted only once according to the first event occurring during the observation period.

次要结局

  • Number of Participants With Angina Pectoris(From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.)
  • Number of Participants With Stroke(From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.)
  • Number of Participants With Pulmonary Embolism(From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.)
  • All-cause mortality(From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.)
  • Number of Participants With Nonfatal Myocardial Infarction(From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.)
  • Number of Participants With Heart Failure(From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.)
  • Number of Participants With Arrhythmia(From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.)

研究者

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验