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

NCT07850492 | Not Yet Recruiting

• 2 other identifiers: HMU-BMH-TROP-MAS-20268726/QD-DHYHN; 648/BM-HDDD
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myocardial Infarction (MI); Perioperative Myocardial Injury; Sepsis; Digestive System Surgical Procedures; Acute Kidney Injury; Postoperative Complication; Heart Injuries

Keywords

High-sensitivity cardiac troponin T; hs-cTnT; Perioperative myocardial injury; PMI; Major abdominal surgery; Cardiovascular risk; 30-day mortality; ESC Guidelines; RCRI

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Within 30 days after surgery

Secondary Outcomes (6)

• Major Adverse Cardiovascular Events (MACE)

  30 days post-surgery

• Severe Sepsis and Septic Shock

  30 days post-surgery

• Major Surgical Complications

  30 days post-surgery

• Prognostic Accuracy of hs-cTnT Kinetics for 30-Day Composite Major Complications and Mortality

  Within 30 days post-surgery

• Length of ICU and Hospital Stay

  Up to discharge / 30 days

Study Arms (2)

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

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

Interventions

High-sensitivity cardiac troponin T (hs-cTnT) surveillance DIAGNOSTIC_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.

Cohort A (PMI); Cohort B (Non-PMI)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bach Mai Hospital: lead
• Hanoi Medical University: collaborator

Study Sites (1)

Bach Mai Hospital

Hanoi, Dong Da, 100000, Vietnam

Location

Related Publications (3)

• 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.

  PMID: 25740400 BACKGROUND

• 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.

  PMID: 36017553 BACKGROUND

• 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.

  PMID: 28444280 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum hs-cTnT, creatinine, electrolytes, blood count

MeSH Terms

Conditions

Myocardial Infarction; Sepsis; Acute Kidney Injury; Postoperative Complications; Heart Injuries

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Thoracic Injuries; Wounds and Injuries

Central Study Contacts

Tu Ba Nguyen, MD, MSc

CONTACT

+84968908819; nguyenbatu@hmu.edu.vn

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

CONTACT

+84916874795; nguyentoanthang@hmu.edu.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head of Department of Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 to 36 months following publication.
• Access Criteria: Qualified researchers with an approved research proposal and signed data use agreement.

Locations

VN (1)