[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658299":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":44,"studyPopulation":45,"armGroups":46,"interventions":56,"overallOfficials":40,"centralContacts":62,"locations":72,"responsibleParty":87,"collaborators":91,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":40,"enrollmentInfo":104,"targetDuration":40,"studyType":107,"phases":40,"briefSummary":108,"conditions":109,"keywords":117,"overallStatus":127,"whyStopped":40,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Bach Mai Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":40},[9,13],{"measure":10,"description":11,"timeFrame":12},"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\u002FL) from preoperative baseline to postoperative 24h or 48h (or between postoperative 24h and 48h), OR any postoperative peak hs-cTnT concentration \\>= 70 ng\u002FL (\\> 5x ULN, Roche Cobas Elecsys STAT assay).","Within 48 hours postoperatively",{"measure":14,"description":15,"timeFrame":16},"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",[18,22,25,28,32,36],{"measure":19,"description":20,"timeFrame":21},"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\u002Fhemorrhagic stroke confirmed by neuroimaging.","30 days post-surgery",{"measure":23,"description":24,"timeFrame":21},"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\u002FL).",{"measure":26,"description":27,"timeFrame":21},"Major Surgical Complications","Incidence of Clavien-Dindo Grade \\>= III complications (anastomotic leak, acute bowel ischemia, secondary peritonitis, intra-abdominal hemorrhage, and unplanned reoperation).",{"measure":29,"description":30,"timeFrame":31},"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 \u002F 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.\n\nThe composite endpoint encompasses:\n\n1. 30-day all-cause mortality;\n2. Major adverse cardiovascular events (MACE: nonfatal cardiac arrest, acute myocardial infarction, acute heart failure, life-threatening arrhythmias, and stroke);\n3. Major surgical and intra-abdominal complications (Clavien-Dindo Grade \\>= III: gastrointestinal anastomotic leak\u002Fdehiscence, acute mesenteric\u002Fintestinal ischemia or gangrene, secondary peritonitis, intra-abdominal hemorrhage, and unplanned reoperation);\n4. 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",{"measure":33,"description":34,"timeFrame":35},"Length of ICU and Hospital Stay","Duration of index postoperative Surgical ICU\u002FPACU stay (days) and total hospital length of stay from surgery to discharge or death.","Up to discharge \u002F 30 days",{"measure":37,"description":38,"timeFrame":39},"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\u002FL 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",null,{"allocation":40,"interventionModel":40,"interventionModelDescription":40,"primaryPurpose":40,"observationalModel":42,"timePerspective":43,"maskingInfo":40},"COHORT","PROSPECTIVE","1. Clinical Rationale and Knowledge Gap:\n\n   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\u002Finfectious 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.\n2. Biomarker Sampling Schedule:\n\n   * T0: Baseline preoperative hs-cTnT drawn within 24 hours prior to surgery.\n   * T1: Postoperative 24 hours (± 6h).\n   * T2: Postoperative 48 hours (± 6h).\n   * Additional measurements (Tx) performed upon clinical indication (new ECG ischemia, hypotension, unexplained arrhythmia).\n3. Core Diagnostic Definitions:\n\n   * ESC 2022 PMI: Delta hs-cTnT \\>= 14 ng\u002FL (calculated as Peak(T1, T2) - T0, or \\|T2 - T1\\|) OR any postoperative peak concentration \\>= 70 ng\u002FL (\\> 5x ULN, Roche Cobas Elecsys STAT assay).\n   * Myocardial Ischemia Symptoms\u002FSigns: Sensed within 24h of troponin elevation: chest\u002Fneck\u002Fjaw\u002Farm 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.\n4. Follow-up Protocol:\n\nTriangulated 30-day follow-up:\n\n* Complete in-hospital record tracking until discharge.\n* Structured telephone interview conducted at Day 30 ± 3 days post-surgery.\n* Cross-verification with Bach Mai Hospital Electronic Medical Record (EMR\u002FHIS) system.","Adult surgical patients with established or potential cardiovascular risk scheduled for or undergoing major abdominal surgery under general anesthesia at Bach Mai Hospital.",[47,52],{"label":48,"type":40,"description":49,"interventionNames":50},"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\u002FL above baseline or between postoperative 24h and 48h, OR any postoperative peak hs-cTnT concentration \\>= 70 ng\u002FL.",[51],"Diagnostic Test: High-sensitivity cardiac troponin T (hs-cTnT) surveillance",{"label":53,"type":40,"description":54,"interventionNames":55},"Cohort B (Non-PMI)","Patients who undergo major abdominal surgery with cardiovascular risk but do not meet the criteria for PMI (delta increase \\\u003C 14 ng\u002FL and peak hs-cTnT \\\u003C 70 ng\u002FL).",[51],[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":40},"DIAGNOSTIC_TEST","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.",[48,53],[63,68],{"name":64,"role":65,"phone":66,"phoneExt":40,"email":67},"Tu Ba Nguyen, MD, MSc","CONTACT","+84968908819","nguyenbatu@hmu.edu.vn",{"name":69,"role":65,"phone":70,"phoneExt":40,"email":71},"Thang Toan Nguyen, MD, PhD, Assoc. Prof.","+84916874795","nguyentoanthang@hmu.edu.vn",[73],{"facility":5,"status":40,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Hanoi","Dong Da","100000","Vietnam","VN",{"type":80,"coordinates":81},"Point",[82,83],105.84117,21.0245,{"lat":83,"lon":82},[86],{"name":64,"role":65,"phone":66,"phoneExt":40,"email":67},{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Nguyen Toan Thang","Associate Professor, Head of Department of Anesthesiology and Intensive Care",[92],{"name":93,"class":6},"Hanoi Medical University","100658299","high-sensitivity-troponin-t-kinetics-and-30-day-outcomes-after-major-abdominal-surgery-trop-mas-100658299",false,"NCT07850492","High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (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","TROP-MAS","Inclusion Criteria:\n\n* 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.\n* Possessing established or potential cardiovascular risk defined by meeting AT LEAST ONE of the following:\n\n  * Age \\>= 65 years; OR\n  * 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 \\\u003C= 0.90), diabetes mellitus requiring treatment, arterial hypertension, dyslipidemia\u002Fhypercholesterolemia, active cigarette smoking, overweight\u002Fobesity (BMI \\>= 25 kg\u002Fm\\^2), family history of premature cardiovascular disease, unexplained cardiac signs\u002Fsymptoms, chronic obstructive pulmonary disease (COPD), baseline chronic renal impairment (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2 or serum creatinine \\> 177 umol\u002FL), or Revised Cardiac Risk Index (RCRI) \\>= 2 points.\n* Signed Informed Consent Form permitting electronic medical record (EMR) data extraction and participation in a 30-day follow-up telephone interview.\n\nExclusion Criteria:\n\n* Active acute myocardial infarction or acute coronary syndrome within 30 days prior to the index surgical procedure.\n* End-stage renal disease (ESRD) on maintenance hemodialysis or peritoneal dialysis.\n* Intraoperative mortality or death within the first 24 hours postoperatively due to acute massive surgical exsanguination.\n* Incomplete postoperative troponin testing protocol (missing both 24h and 48h postoperative blood samples).\n* Patient or legal surrogate withdrawal of consent during the 30-day surveillance period.","ALL","45 Years",{"count":105,"type":106},650,"ESTIMATED","OBSERVATIONAL","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\u002FL or a peak \\> 5x ULN (\\> 70 ng\u002FL). However, validation in Asian populations and major abdominal visceral resections is scarce.\n\nThis 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.",[110,111,112,113,114,115,116],"Myocardial Infarction (MI)","Perioperative Myocardial Injury","Sepsis","Digestive System Surgical Procedures","Acute Kidney Injury","Postoperative Complication","Heart Injuries",[118,119,120,121,122,123,124,125,126],"High-sensitivity cardiac troponin T","hs-cTnT","Perioperative myocardial injury","PMI","Major abdominal surgery","Cardiovascular risk","30-day mortality","ESC Guidelines","RCRI","NOT_YET_RECRUITING","2026-09-24",{"date":130,"type":131},"2026-09-30","ACTUAL",{"date":133,"type":106},"2026-10-01",{"date":135,"type":106},"2027-06-30",{"name":5,"class":6},1]