An observational study in Myocardial Infarction (MI), Perioperative Myocardial Injury and Sepsis, sponsored by Bach Mai Hospital. Not yet recruiting at 1 site in Vietnam. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Bach Mai Hospital · Observational
Major abdominal surgery (MAS) carries a high risk of 30-day mortality (>5%). Perioperative myocardial injury (PMI) and myocardial injury after noncardiac surgery (MINS) frequently develop asymptomatically due to surgical analgesia. The 2022 European Society of Cardiology (ESC) Guidelines recommend routine surveillance with high-sensitivity cardiac troponin (hs-cTn) before and after surgery in high-risk patients, defining PMI by an absolute increase in hs-cTnT >= 14 ng/L or a peak > 5x ULN (> 70 ng/L). However, validation in Asian populations and major abdominal visceral resections is scarce.
This prospective observational cohort study (TROP-MAS) recruits >= 650 consecutive high-cardiovascular-risk patients undergoing major abdominal surgery at Bach Mai Hospital (Hanoi, Vietnam). The study systematically evaluates the incidence and prognostic significance of hs-cTnT kinetics (T0 baseline, T1 24h, T2 48h postoperative) regarding 30-day all-cause mortality, major adverse cardiovascular events (MACE), and severe noncardiac complications (acute kidney injury, sepsis, anastomotic leak, bowel ischemia). Furthermore, it derives and validates population-specific optimal prognostic cut-off values using ROC curve analysis and multivariable Cox modeling.
Clinical Rationale and Knowledge Gap:
Patients with cardiovascular risk undergoing major gastrointestinal, hepatopancreatobiliary, colorectal, or acute abdominal emergency operations experience immense physiological stress. While hs-cTnT is widely accepted as a prognostic biomarker, data specifically delineating the correlation between hs-cTnT elevation and severe surgical/infectious complications (such as anastomotic dehiscence, bowel gangrene, and septic shock) remain sparse. Evidence suggests that microvascular myocardial necrosis and systemic hyperinflammation share common endothelial and microcirculatory pathophysiological pathways.
Biomarker Sampling Schedule:
Core Diagnostic Definitions:
Triangulated 30-day follow-up:
Adult surgical patients with established or potential cardiovascular risk scheduled for or undergoing major abdominal surgery under general anesthesia at Bach Mai Hospital.
Possessing established or potential cardiovascular risk defined by meeting AT LEAST ONE of the following:
Exclusion Criteria:
Patients who develop Perioperative Myocardial Injury (PMI) defined according to the 2022 ESC Guidelines: absolute delta increase in hs-cTnT \>= 14 ng/L above baseline or between postoperative 24h and 48h, OR any postoperative peak hs-cTnT concentration \>= 70 ng/L.
Diagnostic Test: High-sensitivity cardiac troponin T (hs-cTnT) surveillance
Patients who undergo major abdominal surgery with cardiovascular risk but do not meet the criteria for PMI (delta increase \< 14 ng/L and peak hs-cTnT \< 70 ng/L).
Diagnostic Test: High-sensitivity cardiac troponin T (hs-cTnT) surveillance
Serial blood sampling for high-sensitivity cardiac troponin T (hs-cTnT) measurement using the Roche Cobas Elecsys STAT assay: preoperatively within 24 hours before incision (T0), at 24 hours (± 6h) postoperatively (T1), and at 48 hours (± 6h) postoperatively (T2). Additional samples are obtained if ischemic symptoms or signs occur.
Incidence of Perioperative Myocardial Injury (PMI)
Occurrence of Perioperative Myocardial Injury (PMI) defined according to the 2022 ESC Guidelines as an absolute delta increase in high-sensitivity cardiac troponin T (Delta hs-cTnT \>= 14 ng/L) from preoperative baseline to postoperative 24h or 48h (or between postoperative 24h and 48h), OR any postoperative peak hs-cTnT concentration \>= 70 ng/L (\> 5x ULN, Roche Cobas Elecsys STAT assay).
Time frame: Within 48 hours postoperatively
All-Cause Mortality
Cumulative incidence of all-cause death occurring within 30 days after index major abdominal surgery, verified through hospital records, Electronic Medical Records (EMR), and structured Day 30 telephone interview.
Time frame: Within 30 days after surgery
Major Adverse Cardiovascular Events (MACE)
Composite of nonfatal cardiac arrest, nonfatal clinical AMI (Fourth Universal Definition), acute decompensated heart failure, malignant ventricular arrhythmia, and new ischemic/hemorrhagic stroke confirmed by neuroimaging.
Time frame: 30 days post-surgery
Severe Sepsis and Septic Shock
Incidence of severe sepsis and septic shock defined by Sepsis-3 Consensus Criteria (infection with acute SOFA increase \>= 2 points; septic shock requiring vasopressors for MAP \>= 65 mmHg with lactate \> 2 mmol/L).
Time frame: 30 days post-surgery
Major Surgical Complications
Incidence of Clavien-Dindo Grade \>= III complications (anastomotic leak, acute bowel ischemia, secondary peritonitis, intra-abdominal hemorrhage, and unplanned reoperation).
Time frame: 30 days post-surgery
Prognostic Accuracy of hs-cTnT Kinetics for 30-Day Composite Major Complications and Mortality
Discriminative performance measured by Area Under the Receiver Operating Characteristic Curve (AUC / C-statistic) and derivation of optimal population-specific prognostic cut-off thresholds for Peak hs-cTnT and absolute Delta hs-cTnT to predict a 30-day composite major adverse outcome. The composite endpoint encompasses: 1. 30-day all-cause mortality; 2. Major adverse cardiovascular events (MACE: nonfatal cardiac arrest, acute myocardial infarction, acute heart failure, life-threatening arrhythmias, and stroke); 3. Major surgical and intra-abdominal complications (Clavien-Dindo Grade \>= III: gastrointestinal anastomotic leak/dehiscence, acute mesenteric/intestinal ischemia or gangrene, secondary peritonitis, intra-abdominal hemorrhage, and unplanned reoperation); 4. Severe non-cardiac complications (severe sepsis, septic shock by Sepsis-3 criteria, and acute kidney injury KDIGO Stage 2-3).
Time frame: Within 30 days post-surgery
Length of ICU and Hospital Stay
Duration of index postoperative Surgical ICU/PACU stay (days) and total hospital length of stay from surgery to discharge or death.
Time frame: Up to discharge / 30 days
Acute Kidney Injury (AKI) Postoperative Incidence
Occurrence and staging of acute kidney injury classified according to KDIGO (Kidney Disease: Improving Global Outcomes) serum creatinine criteria: Stage 1 (increase \>= 26.5 umol/L within 48h or 1.5-1.9 times baseline), Stage 2 (2.0-2.9 times baseline), Stage 3 (\>= 3.0 times baseline or initiation of renal replacement therapy).
Time frame: During index hospital admission, up to 30 days post-surgery
Plan to share: Yes — De-identified individual participant data underlying the results reported in future publications will be available to qualified researchers upon reasonable academic request. Data will be available beginning 6 months and ending 36 months following article publication. Requests should be directed to the Principal Investigator (nguyenbatu@hmu.edu.vn / nguyentoanthang@hmu.edu.vn). To gain access, data requestors will need to provide a methodologically sound research proposal and sign a data access agreement approved by the institutional ethics committee.
Supporting information: Study protocol, Sap
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Bach Mai Hospital