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NCT Number: NCT07709377

AI-Based Risk Factor Analysis and Prediction Model of MACE in Elderly Hip Fracture Patients Postoperatively

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. All-cause mortality

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

    Number of Participants With death, including death attributable to cardiovascular complications.

  2. Number of Participants With Nonfatal Myocardial Infarction

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

  3. Number of Participants With Heart Failure

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

  4. Number of Participants With Arrhythmia

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

  5. Number of Participants With Angina Pectoris

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

  6. Number of Participants With Stroke

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

  7. Number of Participants With Pulmonary Embolism

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

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Collaborators

  • China-Japan Friendship Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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