Myocardial Injury After Noncardiac Surgery (MINS)NCT07335042
Prediction Model for MINS After Major Hepatobiliary Surgery
An observational study of Myocardial Injury After Noncardiac Surgery (MINS) and Postoperative Complications, run by Beijing Tsinghua Chang Gung Hospital at 6 sites in China.
Trial summary
This multi-center, prospective observational study aims to develop and validate an interpretable prediction model for Myocardial Injury After Noncardiac Surgery (MINS) in patients undergoing major hepatobiliary surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Injury After Noncardiac Surgery (MINS), Postoperative Complications, Liver Neoplasm
- What is being tested?
- Major Hepatobiliary Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,800 participants
- Where
- 6 sitesChina
- Study dates
- 14 Jan 2026to 30 Jun 2027
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1800
Who may be able to join
- Adults (18-85 yr, ASA physical status II-III) undergoing major hepatobiliary surgery were enrolled. Major surgery was defined as duration ≥ 3 h involving hepatectomy (≥ 3 segments) or biliary reconstruction necessitating ICU admission. Eligibility required paired perioperative high-sensitivity cardiac troponin T (hs-cTnT) data and comprehensive documentation of surgical covariates, including surgical approach (laparoscopic vs. open), resection nature (anatomic vs. non-anatomic), number of resected segments, tumor characteristics (size and location), and presence of cirrhosis.
Who cannot join
- preoperative acute myocardial infarction, unstable angina, heart failure, or chronic kidney disease (estimated glomerular filtration rate < 60 ml/ (min · 1.73 m2); (2) undocumented inflow occlusion strategy; or (3) non-imputable missing covariates.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University
Beijing
Zhifeng Gao, MD, +86-15801249466, gzfa02461@btch.edu.cn
- Recruiting
Peking University International Hospital
Beijing
Lin Ding, MD, +86-13269092835, 13269092835@163.com
- Recruiting
The First Affiliated Hospital of Army Medical University
Chongqing
Zhiyu Chen, MD, +86-13983881219, chenzhiyu_umn@163.com
Zhifeng Gao, MD, gzfa02461@btch.edu.cn
- Recruiting
Qingdao West Coast New Area People's Hospital
Qingdao
peng Zhang, MD, +86-16678658917, zhangpeng27309@126.com
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Shandong
Ming Hou, MD, +86-13869183831, 13869183831@126.com
- Recruiting
Zhuhai People's Hospital
Zhuhai
Wenpeng Li, MD, +86-13431577611, liwenpeng324324@163.com
About this study
Official title: Development of an Interpretable Prediction Model for Myocardial Injury After Noncardiac Surgery in Patients Undergoing Major Hepatobiliary Surgery
This multi-center, prospective observational study aims to develop and validate an interpretable prediction model for Myocardial Injury After Noncardiac Surgery (MINS) in patients undergoing major hepatobiliary surgery. The study adopts a nested modeling strategy, starting with baseline risk factors (e.g., RCRI) and stepwise incorporating hepatic inflow occlusion strategies (specifically comparing SPVO vs. Pringle maneuver) and routine intraoperative biomarkers. The model's performance will be evaluated using AUC, Net Reclassification Improvement (NRI), and Decision Curve Analysis (DCA), followed by interpretability analysis using SHAP values and external validation in an independent cohort.
Read the detailed description
Study Design and Methodology: The study consists of four consecutive phases aimed at constructing a robust and interpretable prediction model for MINS.
- Multi-center Cohort Standardization: Based on clinical data from multiple participating centers, the investigators will establish a standardized structural dataset. Strict inclusion and exclusion criteria will be applied. The process involves rigorous data cleaning and normalization to harmonize demographics, surgical operation details, and perioperative hemodynamic parameters across different centers, laying the foundation for model construction.
- Nested Modeling and Performance Evaluation: A nested modeling strategy will be employed to assess the incremental predictive value of specific surgical and biological variables: Model A (Baseline): Constructed using standard baseline variables such as the Revised Cardiac Risk Index (RCRI). Model B (+Surgical Technique): Incorporates hepatic inflow occlusion strategies, specifically comparing SPVO (Selective Pringle Vascular Occlusion) vs. Pringle maneuver, along with occlusion duration and frequency. Model C (Full Model): Further incorporates MINS-related biomarkers. Model performance will be comprehensively evaluated using: Discrimination: Area Under the Receiver Operating Characteristic Curve (AUC). Calibration: Calibration plots. Clinical Utility: Net Reclassification Improvement (NRI) and Decision Curve Analysis (DCA) to assess the improvement in risk stratification and clinical net benefit after adding new variables.
- Model Interpretability Analysis: To enhance the transparency of the model ("White-box" approach), SHAP (SHapley Additive exPlanations) values or similar methods will be utilized. This will quantify and visualize the specific contribution (weight) of key variables, such as SPVO usage, to the individual risk prediction, aligning the statistical results with clinical medical reasoning.
- External Validation: The final model will undergo validation using an independent external clinical cohort. This step aims to test the stability and generalizability of the model across different center data, defining its applicable scope in real-world clinical scenarios.
- Conditions
- Myocardial Injury After Noncardiac Surgery (MINS), Postoperative Complications, Liver Neoplasm, Hepatobiliary Diseases
- Being tested
- Major Hepatobiliary Surgery
- Keywords
- MINS, Major Hepatobiliary Surgery, Hepatectomy, Hepatic Inflow Occlusion, Pringle Maneuver, Prediction Model, High-sensitivity Cardiac Troponin
- Medical subject headings
- Postoperative Complications, Liver Neoplasms, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major Hepatobiliary SurgeryProcedure or surgery
Patients undergo standard major hepatobiliary surgery (e.g., hepatectomy). The specific surgical strategy, including the method of hepatic inflow occlusion (e.g., Pringle maneuver or SPVO), is determined by the attending surgeon based on routine clinical practice and patient condition, not by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Training set | Cases in this subset are used for model training, testing and internal validation Receives: Procedure: Major Hepatobiliary Surgery | |
| External validation set | This part is for external validation of predictive models. Receives: Procedure: Major Hepatobiliary Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the receiver operating characteristic curve (AUC) of predictive model
The area under the receiver operating characteristic curve (AUC) for predicting myocardial injury after noncardiac surgery (MINS) in patients undergoing major hepatobiliary surgery
Measured: Within 3 days after surgery
Secondary outcomes (4)
Model calibration
assessed by calibration curve / Hosmer-Lemeshow test
Measured: Within 3 days after surgery
Decision curve analysis (DCA)-derived clinical net benefit
Measured: Within 3 days after surgery
Model stability and generalizability in the external validation cohort
Measured: Within 3 days after surgeries
Contribution weight of key variables (SPVO, biomarkers) analyzed via SHAP
Measured: Within 3 days after surgeires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start14 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Injury After Noncardiac Surgery (MINS)Studies 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
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhifeng Gao, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Zhifeng Gao, MD, Principal investigator, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335042
- Sponsor's protocol ID
- 26082-4-01
- Status last verified
- Jun 2026
- First submitted
- 4 Jan 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Interpretable Prediction Model for Myocardial Injury After Noncardiac Surgery in Patients Undergoing Major Hepatobiliary Surgery
- ClinicalTrials.gov ID
- NCT07335042
- Acronym / sponsor ID
- 26082-4-01
- Conditions
- Myocardial Injury After Noncardiac Surgery (MINS), Postoperative Complications, Liver Neoplasm, Hepatobiliary Diseases
- Keywords
- MINS, Major Hepatobiliary Surgery, Hepatectomy, Hepatic Inflow Occlusion, Pringle Maneuver, Prediction Model, High-sensitivity Cardiac Troponin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Jan 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 multi-center, prospective observational study aims to develop and validate an interpretable prediction model for Myocardial Injury After Noncardiac Surgery (MINS) in patients undergoing major hepatobiliary surgery. The study adopts a nested modeling strategy, starting with baseline risk factors (e.g., RCRI) and stepwise incorporating hepatic inflow occlusion strategies (specifically comparing SPVO vs. Pringle maneuver) and routine intraoperative biomarkers. The model's performance will be evaluated using AUC, Net Reclassification Improvement (NRI), and Decision Curve Analysis (DCA), followed by interpretability analysis using SHAP values and external validation in an independent cohort.
Detailed description
Study Design and Methodology: The study consists of four consecutive phases aimed at constructing a robust and interpretable prediction model for MINS.
- Multi-center Cohort Standardization: Based on clinical data from multiple participating centers, the investigators will establish a standardized structural dataset. Strict inclusion and exclusion criteria will be applied. The process involves rigorous data cleaning and normalization to harmonize demographics, surgical operation details, and perioperative hemodynamic parameters across different centers, laying the foundation for model construction.
- Nested Modeling and Performance Evaluation: A nested modeling strategy will be employed to assess the incremental predictive value of specific surgical and biological variables: Model A (Baseline): Constructed using standard baseline variables such as the Revised Cardiac Risk Index (RCRI). Model B (+Surgical Technique): Incorporates hepatic inflow occlusion strategies, specifically comparing SPVO (Selective Pringle Vascular Occlusion) vs. Pringle maneuver, along with occlusion duration and frequency. Model C (Full Model): Further incorporates MINS-related biomarkers. Model performance will be comprehensively evaluated using: Discrimination: Area Under the Receiver Operating Characteristic Curve (AUC). Calibration: Calibration plots. Clinical Utility: Net Reclassification Improvement (NRI) and Decision Curve Analysis (DCA) to assess the improvement in risk stratification and clinical net benefit after adding new variables.
- Model Interpretability Analysis: To enhance the transparency of the model ("White-box" approach), SHAP (SHapley Additive exPlanations) values or similar methods will be utilized. This will quantify and visualize the specific contribution (weight) of key variables, such as SPVO usage, to the individual risk prediction, aligning the statistical results with clinical medical reasoning.
- External Validation: The final model will undergo validation using an independent external clinical cohort. This step aims to test the stability and generalizability of the model across different center data, defining its applicable scope in real-world clinical scenarios.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training set | – | Procedure: Major Hepatobiliary SurgeryCases in this subset are used for model training, testing and internal validation |
| External validation set | – | Procedure: Major Hepatobiliary SurgeryThis part is for external validation of predictive models. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1800
Key inclusion criteria (1 listed)
- Adults (18-85 yr, ASA physical status II-III) undergoing major hepatobiliary surgery were enrolled. Major surgery was defined as duration ≥ 3 h involving hepatectomy (≥ 3 segments) or biliary reconstruction necessitating ICU admission. Eligibility required paired perioperative high-sensitivity cardiac troponin T (hs-cTnT) data and comprehensive documentation of surgical covariates, including surgical approach (laparoscopic vs. open), resection nature (anatomic vs. non-anatomic), number of resected segments, tumor characteristics (size and location), and presence of cirrhosis.
Key exclusion criteria (1 listed)
- preoperative acute myocardial infarction, unstable angina, heart failure, or chronic kidney disease (estimated glomerular filtration rate < 60 ml/ (min · 1.73 m2); (2) undocumented inflow occlusion strategy; or (3) non-imputable missing covariates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Major Hepatobiliary SurgeryPatients undergo standard major hepatobiliary surgery (e.g., hepatectomy). The specific surgical strategy, including the method of hepatic inflow occlusion (e.g., Pringle maneuver or SPVO), is determined by the attending surgeon based on routine clinical practice and patient condition, not by the study protocol. | Procedure or surgery | External validation set, Training set |
Primary outcome
The area under the receiver operating characteristic curve (AUC) of predictive model
Time frame: Within 3 days after surgery
The area under the receiver operating characteristic curve (AUC) for predicting myocardial injury after noncardiac surgery (MINS) in patients undergoing major hepatobiliary surgery
4 secondary outcomes
Model calibration
Time frame: Within 3 days after surgery
Decision curve analysis (DCA)-derived clinical net benefit
Time frame: Within 3 days after surgery
Model stability and generalizability in the external validation cohort
Time frame: Within 3 days after surgeries
Contribution weight of key variables (SPVO, biomarkers) analyzed via SHAP
Time frame: Within 3 days after surgeires
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 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Myocardial Injury After Noncardiac Surgery (MINS)
RecruitingPhase 4
The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery
Anesthesia, Surgery With General Anesthesia
Not yet recruitingPhase 4
Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery
Breast Cancer, Myocardial Injury After Noncardiac Surgery (MINS)
Not yet recruitingObservational study
Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2
Myocardial Injury After Noncardiac Surgery (MINS), Bleeding Independently Associated With Mortality After Noncardiac Surgery (BIMS)
Not yet recruiting
SecondarY Prevention and maNagement of Myocardial Injury aftER Noncardiac surGerY (SYNERGY) Pilot Trial
Myocardial Injury After Noncardiac Surgery (MINS)
RecruitingObservational study
Myocardial Injury After Noncardiac Surgery (MINS) in Lumbar Surgery Patients
MYOCARD INFARCTUS, Non Cardiac Surgery
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.
Zhifeng Gao, MD principal investigator
Beijing Tsinghua Changgeng Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Injury After Noncardiac Surgery (MINS) and Postoperative Complications, run by Beijing Tsinghua Chang Gung Hospital at 6 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Contact Zhifeng Gao, MD (+86-15801249466, gzfa02461@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the receiver operating characteristic curve (AUC) of predictive model (time frame: Within 3 days after surgery). 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 15 Jun 2026.