Hip FractureNCT07709377
AI-Based Risk Factor Analysis and Prediction Model of MACE in Elderly Hip Fracture Patients Postoperatively
An observational study of Hip Fracture and MACE, run by Beijing Anzhen Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fracture, MACE, Elderly
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2025to 30 Jun 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥60 years;
- Diagnosis of femoral neck fracture or intertrochanteric fracture, including subtrochanteric fracture;
- Undergoing surgical treatment.
Who cannot join
- Pathological fracture;
- High-energy trauma or multiple injuries;
- Incomplete relevant clinical data;
- Failure to provide written informed consent (prospective cohort only).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Artificial Intelligence-Based Analysis of Risk Factors and Risk Prediction Model for Major Adverse Cardiovascular Events Following Hip Fracture Surgery in the Elderly
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.
Read more
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
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Secondary outcomes (7)
All-cause mortality
Number of Participants With death, including death attributable to cardiovascular complications.
Measured: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Nonfatal Myocardial Infarction
Measured: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Heart Failure
Measured: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Arrhythmia
Measured: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Angina Pectoris
Measured: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Stroke
Measured: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Pulmonary Embolism
Measured: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709377
- Sponsor's protocol ID
- KS2026134
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Individual data sharing
- No: Individual participant data will not be routinely shared because the study involves sensitive clinical information collected from multiple institutions. De-identified data may be considered for sharing upon reasonable request, subject to approval by the participating institutions and ethics committees and the execution of an appropriate data use agreement.
Publications
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.
PubMed 34643797Araguas 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.
PubMed 32360086Kim 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.
PubMed 29721000Kanis 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.
PubMed 22419370
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Based Analysis of Risk Factors and Risk Prediction Model for Major Adverse Cardiovascular Events Following Hip Fracture Surgery in the Elderly
- ClinicalTrials.gov ID
- NCT07709377
- Acronym / sponsor ID
- KS2026134
- Conditions
- Hip Fracture, MACE, Elderly, Perioperative Complications
- Keywords
- Hip fracture; MACE; Elderly; Perioperative complications
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥60 years;
- Diagnosis of femoral neck fracture or intertrochanteric fracture, including subtrochanteric fracture;
- Undergoing surgical treatment.
Key exclusion criteria (4 listed)
- Pathological fracture;
- High-energy trauma or multiple injuries;
- Incomplete relevant clinical data;
- Failure to provide written informed consent (prospective cohort only).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
All-cause mortality
Time frame: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Nonfatal Myocardial Infarction
Time frame: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Heart Failure
Time frame: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Arrhythmia
Time frame: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Angina Pectoris
Time frame: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Stroke
Time frame: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Number of Participants With Pulmonary Embolism
Time frame: From completion of surgery until hospital discharge, death, or postoperative day 30, whichever occurred first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 34643797Luo 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.
- Background: PubMed 32360086Araguas 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.
- Background: PubMed 29721000Kim 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.
- Background: PubMed 22419370Kanis 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.
- Individual participant dataSharing planned: No. Individual participant data will not be routinely shared because the study involves sensitive clinical information collected from multiple institutions. De-identified data may be considered for sharing upon reasonable request, subject to approval by the participating institutions and ethics committees and the execution of an appropriate data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture and MACE, run by Beijing Anzhen Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07709377, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.