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Geriatric PatientsNCT07566013

PREDICTING MINS WITH FRAILTY AND BIOMARKERS IN GERIATRIC SURGERY

An observational study of Geriatric Patients and Postoperative Complications, run by DİLEK KALAYCI at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary objective of this study is to develop and validate a machine learning model that integrates preoperative clinical data, biomarkers, and modified frailty indices (mFI-5) to accurately predict myocardial injury after non-cardiac surgery (MINS) in geriatric patients ($\ge$65 years) undergoing major orthopedic… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Preoperative Risk Assessment and Machine Learning Modeling
How many people
600 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2026to 5 Jun 2026
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: The study population consists of geriatric patients (aged 65 years) undergoing major orthopedic surgery and requiring postoperative intensive care unit follow-up. Eligible participants must have at least one cardiac troponin level measured within the first 72 hours postoperatively. Patients on chronic dialysis due to end-stage renal disease and those with insufficient preoperative laboratory data will be excluded. The population is selected to represent high-risk geriatric patients in a tertiary training and research hospital setting

Who may be able to join

  • All patients aged 65 years and older.
  • Patients undergoing major orthopedic surgery (hip fracture repair, total knee/hip arthroplasty, and revision surgeries).
  • Patients operated on within the designated study period (January 2021 - December 2023).
  • Patients with complete access to preoperative clinical data (comorbidities, medication use) and baseline laboratory parameters (Hemoglobin, Creatinine, Albumin).
  • Patients who had at least one postoperative cardiac troponin (hs-cTn) measurement within the first 72 hours after surgery.

Who cannot join

  • Patients with a documented history of acute myocardial infarction or elevated baseline troponin levels in the preoperative period (to differentiate acute injury from surgical causes).
  • Patients with end-stage renal disease (ESRD) requiring dialysis (as chronic kidney dysfunction persistently elevates baseline troponin levels).
  • Patients with missing critical preoperative data or incomplete postoperative troponin follow-up.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, Ankara, 06630

Other trials in Turkey (Türkiye)

About this study

Official title: THE ROLE OF FRAILTY INDICES AND PREOPERATIVE BIOMARKERS IN PREDICTING MYOCARDIAL INJURY AFTER NON-CARDIAC SURGERY IN ELDERLY ORTHOPEDIC PATIENTS: A MACHINE LEARNING ANALYSIS

The primary objective of this study is to develop and validate a machine learning model that integrates preoperative clinical data, biomarkers, and modified frailty indices (mFI-5) to accurately predict myocardial injury after non-cardiac surgery (MINS) in geriatric patients ($\ge$65 years) undergoing major orthopedic surgery and requiring postoperative intensive care. The research aims to compare the predictive performance of advanced algorithms, such as XGBoost and Random Forest, against traditional clinical risk scores like the Revised Cardiac Risk Index (RCRI), while specifically evaluating the impact of frailty on the model's area under the curve (AUC). Furthermore, by identifying the most critical preoperative predictors, this study seeks to establish an objective clinical decision support mechanism to guide clinicians in the early risk stratification of high-risk geriatric patients.

Read the detailed description

Myocardial injury after non-cardiac surgery (MINS) is defined as a troponin elevation occurring within the first 30 days following a surgical intervention, presumed to be caused by myocardial ischemia. Unlike the traditional diagnosis of myocardial infarction, MINS follows a "silent" course in more than 90% of cases, without ischemic symptoms or ECG changes. However, this silent progression is misleading; the 30-day postoperative mortality risk for patients who develop MINS is approximately 10 times higher than for those who do not. The geriatric orthopedic population, in particular, is in the highest risk group for this complication due to comorbidities and reduced physiological reserve. Currently, tools used in perioperative risk assessment, such as the Revised Cardiac Risk Index (RCRI) or ACS-NSQIP, focus primarily on chronic organ failures and remain insufficient in reflecting the dynamic physiological state of the geriatric patient. The low predictive success (AUC 0.54-0.62) of these scoring systems in the geriatric surgical group proves that clinicians require more precise tools for risk management.The Revised Cardiac Risk Index (RCRI), also known in the literature as the 'Lee Index,' is a widely used scoring system to predict perioperative major adverse cardiac events based on six clinical variables: high-risk surgery type, history of ischemic heart disease, congestive heart failure, history of cerebrovascular disease, preoperative insulin use, and a serum creatinine level above 2 mg/dL. However, RCRI focuses largely on the patient's existing chronic diagnoses; it does not account for the biological reserve loss that develops with aging, the depth of anemia, and specifically, the acute inflammatory response and fluid-electrolyte shifts triggered by orthopedic surgery. This situation significantly limits the sensitivity of RCRI in detecting silent myocardial injury (MINS) in the geriatric population. Given the high surgical urgency and stress in geriatric orthopedic patients, the early prediction of cardiovascular events has become a vital necessity.A review of the existing literature reveals that MINS prediction has focused either solely on clinical risk scores or on individual biomarkers (hs-cTnT, NT-proBNP). However, the concept of frailty, although it indicates the patient's biological reserve independent of chronological age, has not been sufficiently integrated into perioperative risk models. The combined effect of the "objective biological stress" data provided by biomarkers and the "physiological resilience" data provided by frailty indices has not yet been comprehensively modeled, specifically for orthopedic geriatrics. Traditional statistical methods struggle to capture the complex and non-linear relationships between these multidimensional data. There is a lack of a preoperative model in the literature where these variables are synthesized with machine learning algorithms.The primary objective of this study is to develop and validate a machine learning model that accurately predicts myocardial injury (MINS) following surgery in geriatric patients ($\ge$65 years) undergoing major orthopedic surgery and followed in the postoperative intensive care unit, by integrating only preoperative clinical data, biomarkers, and modified frailty indices. In addition to the primary aim of the research, the study intends to: compare the predictive performance of advanced machine learning models (XGBoost, Random Forest) with traditional clinical risk scores (Revised Cardiac Risk Index) used widely in the literature; reveal the impact of adding validated frailty indices (mFI-5) to patients' existing comorbidities on the model's predictive power (AUC); rank the preoperative variables with the highest predictive value in determining MINS risk in geriatric orthopedic patients; and provide a risk classification based on objective data to guide clinicians in the preoperative identification of high-risk patients.

Being tested
Preoperative Risk Assessment and Machine Learning Modeling
Keywords
Machine Learning, XGBoost, Random Forest, Predictive Model, Modified Frailty Index (mFI-5), High-Risk Patient, Perioperative Medicine, MINS
Medical subject headings
Postoperative Complications, Frailty, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative Risk Assessment and Machine Learning ModelingOther

    Standard clinical care for major orthopedic surgery including preoperative assessment of biomarkers (hs-cTnT, NT-proBNP), frailty screening (mFI-5), and clinical data collection for the development of a machine learning-based MINS prediction model.

Study groups in NCT07566013
Study groupRoleWhat they receive
Geriatric Orthopedic Surgery PatientsGeriatric patients aged 65 years and older who undergo major orthopedic surgery and are followed in the postoperative intensive care unit. This cohort includes patients evaluated for myocardial injury after non-cardiac surgery (MINS) using preoperative clinical data, biomarkers, and frailty indices.
Receives: Other: Preoperative Risk Assessment and Machine Learning Modeling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Myocardial Injury after Non-cardiac Surgery (MINS)

    The area under the receiver operating characteristic curve (AUC-ROC)

    ,Percentage of participants)

    Measured: 30 days postoperatively

Secondary outcomes (3)
  1. Comparison of Machine Learning Models vs. Traditional Risk Scores (RCRI).

    AUC-ROC (Area Under the Curve) values.

    Measured: Up to 30 days post-surgery

  2. Identification and ranking of the most significant preoperative predictors for MINS.

    SHAP values or Feature Importance scores.

    Measured: Through study completion, an average of 6 months

  3. Identification and ranking of the most significant preoperative predictors for MINS

    SHAP values or Feature Importance scores.

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start1 Apr 2026
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion5 Jun 2026 (estimated)

Resources

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
Retrospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07566013
Sponsor's protocol ID
2026-04/85
Status last verified
Apr 2026
First submitted
23 Apr 2026
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared to ensure patient confidentiality and to comply with institutional data protection policies. However, study results and the final analysis will be made available through peer-reviewed publication

Questions about this trial

What is this clinical trial studying?

An observational study of Geriatric Patients and Postoperative Complications, run by DİLEK KALAYCI at 1 site in Turkey (Türkiye).

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 5 inclusion and 3 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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?

Incidence of Myocardial Injury after Non-cardiac Surgery (MINS) (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 May 2026.

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