High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS) (TROP-MAS)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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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.
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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).
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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.
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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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Tu Ba Nguyen, MD, MSc
- Telefonnummer: +84968908819
- E-mail: nguyenbatu@hmu.edu.vn
Undersøgelse Kontakt Backup
- Navn: Thang Toan Nguyen, MD, PhD, Assoc. Prof.
- Telefonnummer: +84916874795
- E-mail: nguyentoanthang@hmu.edu.vn
Studiesteder
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Dong Da
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Hanoi, Dong Da, Vietnam, 100000
- Bach Mai Hospital
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Kontakt:
- Tu Ba Nguyen, MD, MSc
- Telefonnummer: +84968908819
- E-mail: nguyenbatu@hmu.edu.vn
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Adult surgical patients with established or potential cardiovascular risk scheduled for or undergoing major abdominal surgery under general anesthesia at Bach Mai Hospital.
Beskrivelse
Inclusion Criteria:
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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.
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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.
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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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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. |
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). |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Perioperative Myocardial Injury (PMI)
Tidsramme: Within 48 hours postoperatively
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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
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All-Cause Mortality
Tidsramme: Within 30 days after surgery
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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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Major Adverse Cardiovascular Events (MACE)
Tidsramme: 30 days post-surgery
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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
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Severe Sepsis and Septic Shock
Tidsramme: 30 days post-surgery
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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
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Major Surgical Complications
Tidsramme: 30 days post-surgery
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Incidence of Clavien-Dindo Grade >= III complications (anastomotic leak, acute bowel ischemia, secondary peritonitis, intra-abdominal hemorrhage, and unplanned reoperation). |
30 days post-surgery
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Prognostic Accuracy of hs-cTnT Kinetics for 30-Day Composite Major Complications and Mortality
Tidsramme: Within 30 days post-surgery
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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:
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Within 30 days post-surgery
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Length of ICU and Hospital Stay
Tidsramme: Up to discharge / 30 days
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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
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Acute Kidney Injury (AKI) Postoperative Incidence
Tidsramme: During index hospital admission, up to 30 days post-surgery
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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
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Karsygdomme
- Hjerte-kar-sygdomme
- Sår og skader
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Hjertesygdomme
- Infektioner
- Systemisk inflammatorisk responssyndrom
- Betændelse
- Infarkt
- Nekrose
- Nyreinsufficiens
- Myokardieiskæmi
- Iskæmi
- Thoracale skader
- Patologiske tilstande, tegn og symptomer
- Akut nyreskade
- Sepsis
- Myokardieinfarkt
- Postoperative komplikationer
- Hjerteskader
Andre undersøgelses-id-numre
- HMU-BMH-TROP-MAS-2026
- 8726/QD-DHYHN; 648/BM-HDDD (Registry Identifier: Doctoral Thesis Protocol; Bach Mai Hospital IRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
6 to 36 months following publication.
IPD-delingsadgangskriterier
Qualified researchers with an approved research proposal and signed data use agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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