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

NCT07709377 | Active Not Recruiting

• 1 other identifier: KS2026134
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hip Fracture; MACE; Elderly; Perioperative Complications

Keywords

Hip fracture; MACE; Elderly; Perioperative complications

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (7)

• 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.

• Number of Participants With Angina Pectoris

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

Study Arms (2)

Derivation cohort

This cohort consists of patients enrolled at Beijing Anzhen Hospital and is used for model development and internal validation.

External validation cohort

This cohort consists of an independent group of patients enrolled at China-Japan Friendship Hospital and is used to evaluate the generalizability and performance of the developed model.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective data will be collected from the electronic medical records of elderly patients with hip fractures who were hospitalized in the orthopedic departments of Beijing Anzhen Hospital, Capital Medical University, and China-Japan Friendship Hospital. Prospective data will be from newly admitted elderly patients with hip fractures who meet the eligibility criteria and undergo surgery enrolled at both study centers from the date of ethics committee approval.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• China-Japan Friendship Hospital: collaborator

Study Sites (2)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (4)

• Luo Y, Jiang Y, Xu H, Lyu H, Zhang L, Yin P, Tang P. Risk of post-operative cardiovascular event in elderly patients with pre-existing cardiovascular disease who are undergoing hip fracture surgery. Int Orthop. 2021 Dec;45(12):3045-3053. doi: 10.1007/s00264-021-05227-7. Epub 2021 Oct 13.

  PMID: 34643797 BACKGROUND

• Araguas MA, Herrera A, Garrido I, Mateo J, Mayoral AP, Munoz M. Risk factors for major adverse cardiovascular events after osteoporotic hip fracture repair surgery. Injury. 2020 Apr;51 Suppl 1:S30-S36. doi: 10.1016/j.injury.2020.03.052. Epub 2020 Apr 25.

  PMID: 32360086 BACKGROUND

• Kim BS, Kim TH, Oh JH, Kwon CH, Kim SH, Kim HJ, Hwang HK, Chung SM. Association between preoperative high sensitive troponin I levels and cardiovascular events after hip fracture surgery in the elderly. J Geriatr Cardiol. 2018 Mar;15(3):215-221. doi: 10.11909/j.issn.1671-5411.2018.03.002.

  PMID: 29721000 BACKGROUND

• Kanis JA, Oden A, McCloskey EV, Johansson H, Wahl DA, Cooper C; IOF Working Group on Epidemiology and Quality of Life. A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporos Int. 2012 Sep;23(9):2239-56. doi: 10.1007/s00198-012-1964-3. Epub 2012 Mar 15.

  PMID: 22419370 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)