- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07566013
PREDICTING MINS WITH FRAILTY AND BIOMARKERS IN GERIATRIC SURGERY
30. April 2026 aktualisiert von: DİLEK KALAYCI
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.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
600
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Ankara
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Ankara, Ankara, Türkei (türkiye), 06630
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Geriatric Orthopedic Surgery Patients
Geriatric 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.
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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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Myocardial Injury after Non-cardiac Surgery (MINS)
Zeitfenster: 30 days postoperatively
|
The area under the receiver operating characteristic curve (AUC-ROC) ,Percentage of participants) |
30 days postoperatively
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Comparison of Machine Learning Models vs. Traditional Risk Scores (RCRI).
Zeitfenster: Up to 30 days post-surgery
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AUC-ROC (Area Under the Curve) values.
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Up to 30 days post-surgery
|
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Identification and ranking of the most significant preoperative predictors for MINS.
Zeitfenster: Through study completion, an average of 6 months
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SHAP values or Feature Importance scores.
|
Through study completion, an average of 6 months
|
|
Identification and ranking of the most significant preoperative predictors for MINS
Zeitfenster: Through study completion, an average of 1 year
|
SHAP values or Feature Importance scores.
|
Through study completion, an average of 1 year
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Dilek Kalaycı, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. April 2026
Primärer Abschluss (Geschätzt)
1. Juni 2026
Studienabschluss (Geschätzt)
5. Juni 2026
Studienanmeldedaten
Zuerst eingereicht
23. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. April 2026
Zuerst gepostet (Tatsächlich)
4. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-04/85
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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