Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT02060760
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2014-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Excess blood is biobanked as EDTA-plasma and heparin samples after being used for the clinical cTnI assay according to IRB approval HSR # 07-2854'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1927}, 'targetDuration': '180 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2014-02-11', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resource utilization', 'timeFrame': 'Up to 6 months after last enrollment', 'description': 'Resource utilization rates including medications (sorted by class), cardiac evaluation procedures(e.g. echocardiogram, angiography, interventions) and speciality consultations will be assessed.'}, {'measure': 'Type 2 AMI Physiologic Assessment', 'timeFrame': 'Up to 6 months after last enrollment', 'description': 'Expert adjudication of the cause of decreased oxygen supply or increased myocardial oxygen demand resulting in positive cTnI measured by both hs-cTnI and contemporary cTnI assays based on pre-specified subtypes, including:\n\n* Decreased Supply\n* Increased Demand\n* Multifactorial of Indeterminate myocardial injury'}, {'measure': 'Troponin in Angiography', 'timeFrame': 'Up to 6 months after last enrollment', 'description': 'cTnI concentration changes will be analyzed among patients who underwent coronary angiography'}], 'primaryOutcomes': [{'measure': 'Incidence of Acute Myocardial Infarction', 'timeFrame': 'Up to 6 months after last enrollment', 'description': 'Adjudicated diagnosis of acute myocardial infarction (AMI) to systematize the potentially earlier (0,3,6h) detection of AMI using the Abbott hs cTnI assay.'}], 'secondaryOutcomes': [{'measure': 'In- hospital mortality', 'timeFrame': 'Up to 6 months after last enrollment'}, {'measure': '180 day mortality', 'timeFrame': 'Up to 6 months after last enrollment'}, {'measure': 'Repeat Cardiac hospitalization', 'timeFrame': 'Up to 6 months after last enrollment'}, {'measure': 'Time to repeat cardiac hospitalization', 'timeFrame': 'Up to 6 months after last enrollment'}, {'measure': 'ACS Diagnosis', 'timeFrame': 'Up to 6 months after last enrollment'}, {'measure': 'Repeat revascularization (bypass surgery versus percutaneous revascularization)', 'timeFrame': 'Up to 6 months after last enrollment'}, {'measure': 'Emergency encounter for chest pain', 'timeFrame': 'Up to 6 months after last enrollment'}, {'measure': 'New diagnosis of Congestive Heart Failure', 'timeFrame': 'Up to 6 months after last enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prospective cohort study', 'Diagnostic accuracy', 'High sensitivity versus contemporary troponin I assay', 'Gender', 'Renal Function'], 'conditions': ['Acute Coronary Syndrome', 'Myocardial Infarction', 'Troponin']}, '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': '30933618', 'type': 'DERIVED', 'citation': 'Sandoval Y, Smith SW, Sexter A, Gunsolus IL, Schulz K, Apple FS. Clinical Features and Outcomes of Emergency Department Patients With High-Sensitivity Cardiac Troponin I Concentrations Within Sex-Specific Reference Intervals. Circulation. 2019 Apr 2;139(14):1753-1755. doi: 10.1161/CIRCULATIONAHA.118.038284. No abstract available.'}, {'pmid': '30849383', 'type': 'DERIVED', 'citation': 'Sandoval Y, Gunsolus IL, Smith SW, Sexter A, Thordsen SE, Carlson MD, Johnson BK, Bruen CA, Dodd KW, Driver BE, Jacoby K, Love SA, Moore JC, Scott NL, Schulz K, Apple FS. Appropriateness of Cardiac Troponin Testing: Insights from the Use of TROPonin In Acute coronary syndromes (UTROPIA) Study. Am J Med. 2019 Jul;132(7):869-874. doi: 10.1016/j.amjmed.2019.01.043. Epub 2019 Mar 5.'}, {'pmid': '30419227', 'type': 'DERIVED', 'citation': 'Cediel G, Sandoval Y, Sexter A, Carrasquer A, Gonzalez-Del-Hoyo M, Bonet G, Boque C, Schulz K, Smith SW, Bayes-Genis A, Apple FS, Bardaji A. Risk Estimation in Type 2 Myocardial Infarction and Myocardial Injury: The TARRACO Risk Score. Am J Med. 2019 Feb;132(2):217-226. doi: 10.1016/j.amjmed.2018.10.022. Epub 2018 Nov 9.'}, {'pmid': '29079658', 'type': 'DERIVED', 'citation': 'Gunsolus I, Sandoval Y, Smith SW, Sexter A, Schulz K, Herzog CA, Apple FS. Renal Dysfunction Influences the Diagnostic and Prognostic Performance of High-Sensitivity Cardiac Troponin I. J Am Soc Nephrol. 2018 Feb;29(2):636-643. doi: 10.1681/ASN.2017030341. Epub 2017 Oct 27.'}, {'pmid': '28701316', 'type': 'DERIVED', 'citation': 'Sandoval Y, Smith SW, Thordsen SE, Bruen CA, Carlson MD, Dodd KW, Driver BE, Jacoby K, Johnson BK, Love SA, Moore JC, Sexter A, Schulz K, Scott NL, Nicholson J, Apple FS. Diagnostic Performance of High Sensitivity Compared with Contemporary Cardiac Troponin I for the Diagnosis of Acute Myocardial Infarction. Clin Chem. 2017 Oct;63(10):1594-1604. doi: 10.1373/clinchem.2017.272930. Epub 2017 Jul 12.'}, {'pmid': '27811203', 'type': 'DERIVED', 'citation': 'Sandoval Y, Smith SW, Shah AS, Anand A, Chapman AR, Love SA, Schulz K, Cao J, Mills NL, Apple FS. Rapid Rule-Out of Acute Myocardial Injury Using a Single High-Sensitivity Cardiac Troponin I Measurement. Clin Chem. 2017 Jan;63(1):369-376. doi: 10.1373/clinchem.2016.264523. Epub 2016 Nov 3.'}]}, 'descriptionModule': {'briefSummary': "Hypothesis: High sensitivity cTnI assays will have improved diagnostic accuracy for type 1 MI compared to contemporary cTnI assays.\n\nThe primary objective of the study is to determine the performance of a high sensitivity cardiac troponin I (hs-cTnI) assay compared to a contemporary cTnI assay for the diagnostic accuracy of type 1 acute myocardial infarction (AMI).\n\nThe diagnostic performance of Abbott's hs-cTnI assay will be evaluated. Investigators will assess the assay's ability to diagnose AMI earlier and to rule out AMI earlier. The sensitivity, specificity, positive predictive value and negative predictive value of the hs-cTnI assay will be evaluated with both a universal cut off as well as with gender and potentially age derived 99th percentile upper reference limits (URL).\n\nInvestigators will evaluate delta hs-cTnI values (pre-specified absolute concentration and percent changes over time) for their ability to contribute to the negative predictive value and hence potentially lead to an earlier rule out of AMI (improved specificity). Additionally, investigators will assess delta changes of the hs-cTnI assay for their potential contribution to the clinical differentiation of type 1 and type 2 (supply demand mismatch) MIs.\n\nLastly, investigators will compare the diagnosis of AMI based on the currently used contemporary assay to the hs-assay, to assess both the incidence of AMI as well as for the time to diagnosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting to Hennepin County Medical Center through the emergency department within the defined study period will be considered for inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Two or more cTnI values ordered for any clinical indication with specimen available for hs cTnI assay\n* 18 years of age or older\n* EKG done on admission / presentation\n* Agree to research disclosure\n\nExclusion Criteria:\n\n* Admission through any venue other an emergency department\n* Repeat admission for the same patient, only primary admission will be assessed\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02060760', 'acronym': 'UTROPIA', 'briefTitle': 'Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Hennepin Healthcare Research Institute'}, 'officialTitle': 'Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes', 'orgStudyIdInfo': {'id': 'HSR 13-3690'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'UTROPIA study cohort', 'description': 'At least two cTnI data points available (including baseline) with blood samples available for hs-cTnI testing. No intervention.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Fred Apple, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis Medical Research Foundation and Hennepin County Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hennepin Healthcare Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Diagnostics Division', 'class': 'INDUSTRY'}, {'name': 'Hennepin County Medical Center, Minneapolis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Fred Apple', 'investigatorAffiliation': 'Hennepin Healthcare Research Institute'}}}}