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

24. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

  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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

650

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

45 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Diagnosetest: 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).
Diagnosetest: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Perioperative Myocardial Injury (PMI)
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Major Adverse Cardiovascular Events (MACE)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bach Mai Hospital

Mitarbeiter

Hanoi Medical University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

31. Mai 2027

Studienabschluss (Geschätzt)

30. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

24. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. September 2026

Zuerst gepostet (Tatsächlich)

30. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Zeitrahmen

6 to 36 months following publication.

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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