High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS) (TROP-MAS)

September 24, 2026 updated by: Nguyen Toan Thang, Bach Mai Hospital

Association Between High-Sensitivity Cardiac Troponin T Kinetics, Postoperative Complications, and 30-Day Mortality in Patients With Cardiovascular Risk Undergoing Major Abdominal Surgery: A Prospective Cohort Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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.

  2. Biomarker Sampling Schedule:

    • T0: Baseline preoperative hs-cTnT drawn within 24 hours prior to surgery.
    • T1: Postoperative 24 hours (± 6h).
    • T2: Postoperative 48 hours (± 6h).
    • Additional measurements (Tx) performed upon clinical indication (new ECG ischemia, hypotension, unexplained arrhythmia).

  3. Core Diagnostic Definitions:

    • ESC 2022 PMI: Delta hs-cTnT >= 14 ng/L (calculated as Peak(T1, T2) - T0, or |T2 - T1|) OR any postoperative peak concentration >= 70 ng/L (> 5x ULN, Roche Cobas Elecsys STAT assay).
    • Myocardial Ischemia Symptoms/Signs: Sensed within 24h of troponin elevation: chest/neck/jaw/arm discomfort, dyspnea, pulmonary edema, ischemic ECG shifts (>= 1 mm ST depression, symmetric T-wave inversion, pathological Q waves, new LBBB), or new wall motion abnormalities on transthoracic echocardiography.

  4. Follow-up Protocol:

Triangulated 30-day follow-up:

  • Complete in-hospital record tracking until discharge.
  • Structured telephone interview conducted at Day 30 ± 3 days post-surgery.
  • Cross-verification with Bach Mai Hospital Electronic Medical Record (EMR/HIS) system.

Study Type

Observational

Enrollment (Estimated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
    • Dong Da
      • Hanoi, Dong Da, Vietnam, 100000
        • Bach Mai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult surgical patients with established or potential cardiovascular risk scheduled for or undergoing major abdominal surgery under general anesthesia at Bach Mai Hospital.

Description

Inclusion Criteria:

  • Scheduled for or undergoing elective, urgent, or emergency major abdominal surgery (pancreatectomy, liver resection, gastrectomy, colorectal surgery, or emergency laparotomy) with expected duration >= 2 hours or major visceral resection.

  • Possessing established or potential cardiovascular risk defined by meeting AT LEAST ONE of the following:

    • Age >= 65 years; OR
    • Age 45 to 64 years with at least one documented cardiovascular risk factor or comorbidity: documented coronary artery disease, congestive heart failure, prior ischemic stroke or TIA, peripheral arterial disease (resting ABI <= 0.90), diabetes mellitus requiring treatment, arterial hypertension, dyslipidemia/hypercholesterolemia, active cigarette smoking, overweight/obesity (BMI >= 25 kg/m^2), family history of premature cardiovascular disease, unexplained cardiac signs/symptoms, chronic obstructive pulmonary disease (COPD), baseline chronic renal impairment (eGFR < 60 mL/min/1.73m^2 or serum creatinine > 177 umol/L), or Revised Cardiac Risk Index (RCRI) >= 2 points.

  • Signed Informed Consent Form permitting electronic medical record (EMR) data extraction and participation in a 30-day follow-up telephone interview.

Exclusion Criteria:

  • Active acute myocardial infarction or acute coronary syndrome within 30 days prior to the index surgical procedure.
  • End-stage renal disease (ESRD) on maintenance hemodialysis or peritoneal dialysis.
  • Intraoperative mortality or death within the first 24 hours postoperatively due to acute massive surgical exsanguination.
  • Incomplete postoperative troponin testing protocol (missing both 24h and 48h postoperative blood samples).
  • Patient or legal surrogate withdrawal of consent during the 30-day surveillance period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort A (PMI)

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

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.
Cohort B (Non-PMI)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Perioperative Myocardial Injury (PMI)
Time Frame: Within 48 hours postoperatively

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).
Within 48 hours postoperatively
All-Cause Mortality
Time Frame: Within 30 days after surgery

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.
Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events (MACE)
Time Frame: 30 days post-surgery

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.
30 days post-surgery
Severe Sepsis and Septic Shock
Time Frame: 30 days post-surgery

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).
30 days post-surgery
Major Surgical Complications
Time Frame: 30 days post-surgery

Incidence of Clavien-Dindo Grade >= III complications (anastomotic leak, acute bowel ischemia, secondary peritonitis, intra-abdominal hemorrhage, and unplanned reoperation).
30 days post-surgery
Prognostic Accuracy of hs-cTnT Kinetics for 30-Day Composite Major Complications and Mortality
Time Frame: Within 30 days post-surgery

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).
Within 30 days post-surgery
Length of ICU and Hospital Stay
Time Frame: Up to discharge / 30 days

Duration of index postoperative Surgical ICU/PACU stay (days) and total hospital length of stay from surgery to discharge or death.
Up to discharge / 30 days
Acute Kidney Injury (AKI) Postoperative Incidence
Time Frame: During index hospital admission, up to 30 days post-surgery

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).
During index hospital admission, up to 30 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bach Mai Hospital

Collaborators

Hanoi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

September 24, 2026

First Submitted That Met QC Criteria

September 24, 2026

First Posted (Actual)

September 30, 2026

Study Record Updates

Last Update Posted (Actual)

September 30, 2026

Last Update Submitted That Met QC Criteria

September 24, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMU-BMH-TROP-MAS-2026
  • 8726/QD-DHYHN; 648/BM-HDDD (Registry Identifier: Doctoral Thesis Protocol; Bach Mai Hospital IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

6 to 36 months following publication.

IPD Sharing Access Criteria

Qualified researchers with an approved research proposal and signed data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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