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Myocardial Infarction (MI)TROP-MASNCT07850492

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

An observational study of Myocardial Infarction (MI) and Perioperative Myocardial Injury, run by Bach Mai Hospital at 1 site in Vietnam.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
High-sensitivity cardiac troponin T (hs-cTnT) surveillance
How many people
650 participants
Where
1 siteVietnam
Study dates
1 Oct 2026to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tu Ba Nguyen, MD, MSc contact

+84968908819

nguyenbatu@hmu.edu.vn

Thang Toan Nguyen, MD, PhD, Assoc. Prof. contact

+84916874795

nguyentoanthang@hmu.edu.vn

Vietnam1 site

  • Bach Mai Hospital

    Hanoi, Dong Da, 100000

    Tu Ba Nguyen, MD, MSc, +84968908819, nguyenbatu@hmu.edu.vn

Other trials in Vietnam

About this study

Official title: 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.

Read the 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).
  1. 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.
  1. 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.
Being tested
High-sensitivity cardiac troponin T (hs-cTnT) surveillance
Keywords
High-sensitivity cardiac troponin T, hs-cTnT, Perioperative myocardial injury, PMI, Major abdominal surgery, Cardiovascular risk, 30-day mortality, ESC Guidelines, RCRI
Medical subject headings
Myocardial Infarction, Sepsis, Acute Kidney Injury, Postoperative Complications, Heart Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-sensitivity cardiac troponin T (hs-cTnT) surveillanceDiagnostic test

    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.

Study groups in NCT07850492
Study groupRoleWhat they receive
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.
Receives: Diagnostic Test: High-sensitivity cardiac troponin T (hs-cTnT) surveillance
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).
Receives: Diagnostic Test: High-sensitivity cardiac troponin T (hs-cTnT) surveillance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Within 48 hours postoperatively

  2. 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.

    Measured: Within 30 days after surgery

Secondary outcomes (6)

  1. 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.

    Measured: 30 days post-surgery

  2. 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).

    Measured: 30 days post-surgery

  3. Major Surgical Complications

    Incidence of Clavien-Dindo Grade >= III complications (anastomotic leak, acute bowel ischemia, secondary peritonitis, intra-abdominal hemorrhage, and unplanned reoperation).

    Measured: 30 days post-surgery

  4. 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).

    Measured: Within 30 days post-surgery

  5. 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.

    Measured: Up to discharge / 30 days

  6. 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).

    Measured: During index hospital admission, up to 30 days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07850492
Sponsor's protocol ID
HMU-BMH-TROP-MAS-2026
Other IDs
8726/QD-DHYHN; 648/BM-HDDD
Acronym
TROP-MAS
Status last verified
Sep 2026
First submitted
24 Sep 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Noordzij PG, van Geffen O, Dijkstra IM, Boerma D, Meinders AJ, Rettig TC, Eefting FD, van Loon D, van de Garde EM, van Dongen EP. High-sensitive cardiac troponin T measurements in prediction of non-cardiac complications after major abdominal surgery. Br J Anaesth. 2015 Jun;114(6):909-18. doi: 10.1093/bja/aev027. Epub 2015 Mar 3.

    PubMed 25740400

  • Halvorsen S, Mehilli J, Cassese S, Hall TS, Abdelhamid M, Barbato E, De Hert S, de Laval I, Geisler T, Hinterbuchner L, Ibanez B, Lenarczyk R, Mansmann UR, McGreavy P, Mueller C, Muneretto C, Niessner A, Potpara TS, Ristic A, Sade LE, Schirmer H, Schupke S, Sillesen H, Skulstad H, Torracca L, Tutarel O, Van Der Meer P, Wojakowski W, Zacharowski K; ESC Scientific Document Group. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J. 2022 Oct 14;43(39):3826-3924. doi: 10.1093/eurheartj/ehac270. No abstract available.

    PubMed 36017553

  • Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.

    PubMed 28444280

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction (MI) and Perioperative Myocardial Injury, run by Bach Mai Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tu Ba Nguyen, MD, MSc (+84968908819, nguyenbatu@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Perioperative Myocardial Injury (PMI) (time frame: Within 48 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07850492, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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