Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-26 @ 8:28 PM
Study NCT ID:
NCT04772157
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2021-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe Emergency Department DIscharGE Rate (SEIGE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood and plasma tested on the Siemens POC HS cTn-I Analyzer'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine the incidence of undetectable(<LoD), measurable (LoD - 99th percentile), and increased (>99th percentile) cTn concentrations for the Siemens POC HS cTn-I Test System', 'timeFrame': 'Day 1', 'description': 'Examine the incidence of undetectable(\\<LoD), measurable (LoD - 99th percentile), and increased (\\>99th percentile) cTn concentrations for the Siemens POC HS cTn-I Test System in comparison to a high sensitivity cTnI assay (Abbott \\& Siemens Healthineers) to determine the potential impact on positivity rate, defined by sex-specific 99th percentiles.'}, {'measure': 'Examine Concordance', 'timeFrame': 'Day 1', 'description': 'Examine concordance (dis) between hs-cTnI in comparison to a high sensitivity (Abbott \\& Siemens Healthineers) cTnI assay'}, {'measure': 'Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction', 'timeFrame': 'Day 1', 'description': 'Examine the diagnostic performance for a) acute myocardial injury and b) acute myocardial infarction based on various diagnostic strategies using hs-cTnI measurement(s), as follows:\n\n1. Single measurement strategies\n\n 1. Limit of detection (LoD)\n 2. Concentration threshold tailored to meet a clinical need: Derive an optimal rule-out ng/L cutoff for Siemens POC HS cTn-I Test System.\n2. Accelerated serial sampling (0/2h protocol)\n\n 1. Using the both sex-specific and overall 99th percentiles\n 2. Delta (absolute concentration serial change value, 0-2h) analysis'}, {'measure': 'Describe the incidence, clinical characteristics and outcomes of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs', 'timeFrame': 'Day 1', 'description': 'Describe the incidence, clinical characteristics and outcomes of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs, including patients categorized with acute myocardial injury and acute myocardial infarction, including type 1 and 2 myocardial infarction following the 4th Universal Definition of Myocardial Infarction.'}, {'measure': 'Impact on the incidence of myocardial injury and myocardial infarction diagnoses.', 'timeFrame': 'Day 1', 'description': "Examine the potential impact on the incidence of myocardial injury and myocardial infarction diagnoses using hs-cTnI upon clinical practice implementation with a comparison to the hospital's final ICD-10 code diagnosis of type 1 and type 2 MIs."}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'up to 30 days', 'description': 'any death'}, {'measure': 'Cardiac mortality', 'timeFrame': 'up to 30 days', 'description': 'death due to cardiac reasons'}, {'measure': 'Adjudicated index acute myocardial infarction according to 4th UDMI', 'timeFrame': 'on admission', 'description': 'acute myocardial infarction, including sub-types following the Fourth Universal Definition of Myocardial Infarction'}, {'measure': 'Safety Outcome - MACE', 'timeFrame': '30 days', 'description': 'Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Troponin', 'acute myocardial injury', 'acute myocardial infarction', 'Siemens POC', 'Siemens POC Atellica® VTLi', 'Siemens POC HS cTn-I'], 'conditions': ['Acute Myocardial Infarction', 'Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '37131096', 'type': 'DERIVED', 'citation': 'Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S; ARTEMIS study group. Personalized diagnosis in suspected myocardial infarction. Clin Res Cardiol. 2023 Sep;112(9):1288-1301. doi: 10.1007/s00392-023-02206-3. Epub 2023 May 2.'}, {'pmid': '36314160', 'type': 'DERIVED', 'citation': 'Apple FS, Smith SW, Greenslade JH, Sandoval Y, Parsonage W, Ranasinghe I, Gaikwad N, Schulz K, Stephensen L, Schmidt CW, Okeson B, Cullen L; SAMIE Investigators. Single High-Sensitivity Point-of-Care Whole-Blood Cardiac Troponin I Measurement to Rule Out Acute Myocardial Infarction at Low Risk. Circulation. 2022 Dec 20;146(25):1918-1929. doi: 10.1161/CIRCULATIONAHA.122.061148. Epub 2022 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'The Siemens POC High Sensitivity Troponin-I Test System is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTn-I) in fresh human capillary (fingerstick) whole blood, and lithium-heparinized venous whole blood or plasma, to be used by healthcare professionals at the point of care (POC) as well as in the clinical laboratory.\n\nThe Siemens POC High Sensitivity Troponin-I Test System is to be used as an aid in the diagnosis of myocardial infarction (MI).', 'detailedDescription': 'Study purpose/objective:\n\n* Evaluate the clinical performance of the Siemens POC HS cTn-I test system for the diagnosis and rule out of AMI in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.\n* Correlate the blood and plasma outcomes on the Siemens POC HS cTn-I test system as function of the corresponding hematocrit (Hct) values.\n\nHypothesis: The Siemens POC HS cTn-I Test System will offer an excellent diagnostic performance for acute myocardial injury and acute myocardial infarction, as well as expedite the risk stratification of patients for early discharge from the emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients (goal, 1000 patients over 4 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS event.\n2. Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement.\n3. At least one 12-lead electrocardiogram\n\nExclusion Criteria\n\n1. Less than 21 years old\n2. Pregnancy\n3. Trauma\n4. Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes\n5. Did not present through the ED\n6. Transferred from an outside hospital or clinic.'}, 'identificationModule': {'nctId': 'NCT04772157', 'acronym': 'SEIGE', 'briefTitle': 'Safe Emergency Department DIscharGE Rate (SEIGE)', 'organization': {'class': 'OTHER', 'fullName': 'Hennepin Healthcare Research Institute'}, 'officialTitle': 'Evaluation of the Siemens POC HS CTn-I Test System', 'orgStudyIdInfo': {'id': 'SEIGE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort', 'description': 'Study population: Prospective, observational cohort study of consecutives patients (goal, 1000 patients over 4 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.', 'interventionNames': ['Diagnostic Test: Cardiac Troponin Testing']}], 'interventions': [{'name': 'Cardiac Troponin Testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lithium heparin whole blood and plasma samples will be measured with Siemens POC High Sensitivity Troponin-I Test System.', 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin Healthcare Research Institute / Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Fred S Apple, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hennepin Healthcare Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hennepin Healthcare Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Siemens Healthineers', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}