[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582305":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":63,"collaborators":43,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":43,"enrollmentInfo":76,"targetDuration":43,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"POC Group","EXPERIMENTAL","For patients randomized to the POC group, the Siemens Atellica VTLi kit will be used. This hs-cTnI test employs a two-site sandwich immunoassay, where anti-cTnI antibodies conjugated to paramagnetic particles bind to cTnI. The particles are manipulated by magnetic fields, allowing optical detection. The biomarker concentration is calculated using a calibration curve.\n\nThe primary sample is whole capillary blood, collected by fingertip puncture. Additionally, patients will have venous ultrasensitive troponin collected using the local laboratory.\n\nReference values (99th percentile, pg\u002FmL): Women: 18.5 - Men: 27.1.\n\nThe cTnI values between 0 and LoD are reported as \\\u003CLoD; values above 1250 pg\u002FmL as \\>1250 pg\u002FmL. Samples will be taken at times 0 and 1 hour. Analysis will follow the manufacturer's guidelines.",[13],"Diagnostic Test: Point-of-care ultrasensitive troponin testing",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","For patients randomized to the ultrasensitive troponin dosing arm using the local laboratory, the ABBOTT Alinity i kit will be used. Samples will be taken at 0 and 1 hour after admission. The sample for this analysis will be collected by venipuncture and should be drawn into serum tubes with a separator (5 mL capacity).\n\nThe Alinity i STAT High Sensitive Troponin-I assay is a chemiluminescence microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin I (cTnI) in serum and plasma using the Alinity i analyzer. The analysis will be conducted following the manufacturer's instructions. The measurement range of the assay is 10 to 50,000 pg\u002FmL.\n\nPopulation reference values (99th percentile, pg\u002FmL):\n\nWomen (21-75 years): 15.6 Men (21-73 years): 34.2",[19],"Diagnostic Test: Laboratory-based ultrasensitive troponin testing",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Point-of-care ultrasensitive troponin testing","For patients randomized to the ultrasensitive troponin dosing arm using point-of-care (POC) technology, the Atellica® VTLi Patient-side Immunoassay Analyzer (Siemens Healthineers) will be used. This high-sensitivity troponin I (hs-cTnI) test utilizes Magnotech® Technology with paramagnetic particles and external magnetic fields, providing rapid results (\\~8 minutes) using whole capillary blood collected via fingertip puncture, and\u002For with direct withdrawal from the test tube. Additionally, venous blood samples will be collected for laboratory comparison. The assay measures hs-cTnI within a range of 0-1250 pg\u002FmL, with values \\\u003CLoD and \\>1250 pg\u002FmL recorded accordingly. Samples will be collected at 0 and 1 hour. Reference values (99th percentile, pg\u002FmL): Women: 18.5, Men: 27.1. This intervention enables bedside testing, reducing turnaround time compared to standard laboratory assays, facilitating early myocardial infarction diagnosis.",[9],[27],"Atellica® VTLi Patient-side Immunoassay Analyzer",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Laboratory-based ultrasensitive troponin testing","For patients randomized to the ultrasensitive troponin dosing arm using the local laboratory, the Alinity™ i STAT High Sensitive Troponin-I assay (Abbott) will be used. Samples will be taken at 0 and 1 hour after admission by venipuncture and collected in 5 mL serum tubes with a separator. This chemiluminescence microparticle immunoassay (CMIA) quantifies cardiac troponin I (cTnI) in serum and plasma using the Alinity™ i analyzer, with a measurement range of 10-50,000 pg\u002FmL. Analysis will follow the manufacturer's instructions. Reference values (99th percentile, pg\u002FmL): Women (21-75 years): 15.6, Men (21-73 years): 34.2.",[15],[33],"Alinity™ i STAT High Sensitive Troponin-I assay",[35],{"name":36,"affiliation":5,"role":37},"Ludhmila A Hajjar, Professor","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"José León","CONTACT","+55 (11) 2661-5795",null,"aro@incor.usp.br",[46],{"facility":47,"status":48,"city":49,"state":43,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Instituto do Coração HCFMUSP","RECRUITING","São Paulo","05403-000","Brazil","BR",{"type":54,"coordinates":55},"Point",[56,57],-46.63611,-23.5475,{"lat":57,"lon":56},[60,61],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":62,"role":37,"phone":43,"phoneExt":43,"email":43},"Ludhmila Hajjar",{"type":37,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Ludhmila Abrahão Hajjar MD, PhD","Full Professor of Emergency Medicine","100582305","effect-of-point-of-care-analysis-of-ultrasensitive-troponin-i-on-length-of-hospital-stay-in-patients-with-cardiac-chest-pain-poc-troponina-100582305",false,"NCT06861582","Effect of Point-of-care Analysis of Ultrasensitive Troponin I on Length of Hospital Stay in Patients With Cardiac Chest Pain (POC Troponina)","Effect of Point-of-care Analysis of Ultrasensitive Troponin I on Length of Hospital Stay in Patients With Cardiac Chest Pain: a Randomized Study (POC Troponina)","POC Troponina","Inclusion Criteria:\n\n* Patients aged ≥ 18 years.\n* Patients arriving in the emergency room with symptoms suggestive of ACS, with onset of pain between 3 and 12 hours after arrival, in whom serial troponin dosing is planned for investigation.\n* Signature of the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Patients presenting with ACS with ST-segment elevation on the 12-lead ECG on arrival at hospital.\n* Patients with conditions that interfere with the interpretation of troponin dosage (chronic renal failure, cancer, chronic lung diseases).\n* Pregnant or breastfeeding patients.\n* Patients already included in other clinical research protocols.","ALL","18 Years",{"count":77,"type":78},200,"ESTIMATED","INTERVENTIONAL",[81],"NA","This clinical study aims to compare two different methods for measuring high-sensitivity troponin I, a key biomarker used to diagnose heart attacks.\n\nThe primary research question is: Does the use of the Atellica VTLi kit from Siemens for high-sensitivity troponin I (hs-cTnI) testing at the point of care (POC) significantly reduce the average time from admission to hospital discharge compared to the conventional laboratory methodology using the Alinity i kit from ABBOTT?\n\nParticipant will:\n\n* Patients aged ≥ 18 years.\n* Patients arriving in the emergency room with symptoms suggestive of ACS, with onset of pain between 3 and 12 hours after arrival, in whom serial troponin dosing is planned for investigation.\n* Signature of the Informed Consent Form (ICF).\n\nResearchers will analyze whether the point-of-care testing method helps speed up the hospital discharge process compared to the standard laboratory approach. They will also compare the accuracy of the test results, the time taken for clinical decisions, and the overall cost-effectiveness of the two methods.",[84,85,86],"Acute Coronary Syndromes (ACS)","Troponin I","Point-of-Care Testing",[88,89,85,86,90,91,92,93,94],"Acute Coronary Syndrome","Non-ST Elevation Myocardial Infarction","Biomarkers","Emergency Service, Hospital","Myocardial Ischemia","Cardiovascular Diseases","Hospital Length of Stay","2025-04-07",{"date":97,"type":98},"2025-04-08","ACTUAL",{"date":100,"type":98},"2025-03-10",{"date":102,"type":78},"2026-03",{"name":5,"class":6},1]