NCT07335042 Prediction Model for MINS After Major Hepatobiliary Surgery
| NCT ID | NCT07335042 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tsinghua Chang Gung Hospital |
| Condition | Myocardial Injury After Noncardiac Surgery (MINS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,800 participants |
| Start Date | 2026-01-14 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,800 participants in total. It began in 2026-01-14 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: (1) 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.
Contact & Investigator
Zhifeng Gao, MD
PRINCIPAL INVESTIGATOR
Beijing Tsinghua Changgeng Hospital
Frequently Asked Questions
Who can join the NCT07335042 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Myocardial Injury After Noncardiac Surgery (MINS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07335042 currently recruiting?
Yes, NCT07335042 is actively recruiting participants. Contact the research team at gzfa02461@btch.edu.cn for enrollment information.
Where is the NCT07335042 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Chongqing, China, Qingdao, China and 2 additional locations.
Who is sponsoring the NCT07335042 clinical trial?
NCT07335042 is sponsored by Beijing Tsinghua Chang Gung Hospital. The principal investigator is Zhifeng Gao, MD at Beijing Tsinghua Changgeng Hospital. The trial plans to enroll 1,800 participants.