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

24 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  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.

Studietype

Observationeel

Inschrijving (Geschat)

650

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

45 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Diagnostische toets: 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).
Diagnostische toets: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Perioperative Myocardial Injury (PMI)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Major Adverse Cardiovascular Events (MACE)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bach Mai Hospital

Medewerkers

Hanoi Medical University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

31 mei 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

24 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 september 2026

Eerst geplaatst (Werkelijk)

30 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

6 to 36 months following publication.

IPD-toegangscriteria voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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