Viewing Study NCT01608100

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-26 @ 12:16 PM
Ignite Modification Date: 2025-12-29 @ 6:53 PM
Study NCT ID: NCT01608100
Status: COMPLETED
Last Update Posted: 2015-03-17
First Post: 2012-05-21
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Evaluation of a New Cardiac Biomarker Assay
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karla.grasso@abbott.com', 'phone': '1 224-667-5602', 'title': 'Karla Grasso, Clinical Research Manager', 'organization': 'Abbott Diagnostics Division'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Some tube types and some time points may not have been obtained for each subject. Every attempt was made to collect all tube types within the time point windows described.'}}, 'adverseEventsModule': {'timeFrame': 'Duration of subject emergency department visit: 24 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'ARCHITECT STAT High Sensitive Troponin I Assay Testing', 'description': 'All subjects will have their blood tested by the investigational Troponin I assay.\n\nARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.\n\nResults obtained will be used to assess the prognosis of subjects with a troponin result for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.\n\nTroponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit.', 'otherNumAtRisk': 1101, 'otherNumAffected': 0, 'seriousNumAtRisk': 1101, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Performance - Area Under the Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1066', 'groupId': 'OG000'}, {'value': '1088', 'groupId': 'OG001'}, {'value': '1029', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Area Under the Curve in K2 EDTA', 'description': 'Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).'}, {'id': 'OG001', 'title': 'Area Under the Curve in Lithium Heparin Separator', 'description': 'Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).'}, {'id': 'OG002', 'title': 'Area Under the Curve in Serum Separator', 'description': 'Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).'}], 'classes': [{'title': 'Area Under the Curve: 0-2 hours', 'categories': [{'measurements': [{'value': '0.9326', 'groupId': 'OG000', 'lowerLimit': '0.9048', 'upperLimit': '0.9604'}, {'value': '0.9197', 'groupId': 'OG001', 'lowerLimit': '0.8914', 'upperLimit': '0.9480'}, {'value': '0.9412', 'groupId': 'OG002', 'lowerLimit': '0.9102', 'upperLimit': '0.9722'}]}]}, {'title': 'Area Under the Curve: 2-4 hours', 'categories': [{'measurements': [{'value': '0.9431', 'groupId': 'OG000', 'lowerLimit': '0.9081', 'upperLimit': '0.9782'}, {'value': '0.9349', 'groupId': 'OG001', 'lowerLimit': '0.8986', 'upperLimit': '0.9712'}, {'value': '0.9419', 'groupId': 'OG002', 'lowerLimit': '0.9041', 'upperLimit': '0.9796'}]}]}, {'title': 'Area Under the Curve: 4-9 hours', 'categories': [{'measurements': [{'value': '0.9503', 'groupId': 'OG000', 'lowerLimit': '0.9419', 'upperLimit': '0.9857'}, {'value': '0.9498', 'groupId': 'OG001', 'lowerLimit': '0.9190', 'upperLimit': '0.9805'}, {'value': '0.9449', 'groupId': 'OG002', 'lowerLimit': '0.9046', 'upperLimit': '0.9852'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Area Under the Curve', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9326', 'ciLowerLimit': '0.9048', 'ciUpperLimit': '0.9604', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Area Under the Curve', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9431', 'ciLowerLimit': '0.9081', 'ciUpperLimit': '0.9782', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Area Under the Curve', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9503', 'ciLowerLimit': '0.9419', 'ciUpperLimit': '0.9857', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Area Under the Curve', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9197', 'ciLowerLimit': '0.8914', 'ciUpperLimit': '0.9480', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Area Under the Curve', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9349', 'ciLowerLimit': '0.8986', 'ciUpperLimit': '0.9712', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Area Under the Curve', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9498', 'ciLowerLimit': '0.9190', 'ciUpperLimit': '0.9805', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Area Under the Curve', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9412', 'ciLowerLimit': '0.9102', 'ciUpperLimit': '0.9722', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Area Under the Curve', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9419', 'ciLowerLimit': '0.9041', 'ciUpperLimit': '0.9796', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Area Under the Curve', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9449', 'ciLowerLimit': '0.9046', 'ciUpperLimit': '0.9852', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department', 'description': "The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).", 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.'}, {'type': 'SECONDARY', 'title': 'Prognosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1064', 'groupId': 'OG000'}, {'value': '1064', 'groupId': 'OG001'}, {'value': '1085', 'groupId': 'OG002'}, {'value': '1085', 'groupId': 'OG003'}, {'value': '1027', 'groupId': 'OG004'}, {'value': '1027', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '30-day Prognosis for K2 EDTA Tube Type', 'description': 'The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.'}, {'id': 'OG001', 'title': '90-day Prognosis for K2 EDTA Tube Type', 'description': 'The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.'}, {'id': 'OG002', 'title': '30-day Prognosis for Lithium Heparin Separator Tube Type', 'description': 'The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.'}, {'id': 'OG003', 'title': '90-day Prognosis for Lithium Heparin Separator Tube Type', 'description': 'The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.'}, {'id': 'OG004', 'title': '30-day Prognosis for Serum Separator Tube Type', 'description': 'The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.'}, {'id': 'OG005', 'title': '90-day Prognosis for Serum Separator Tube Type', 'description': 'The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.'}], 'classes': [{'title': 'MACE/ACM with Troponin value </= cutoff', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}]}, {'title': 'No MACE/ACM (*Censored) with TnI value </= cutoff', 'categories': [{'measurements': [{'value': '802', 'groupId': 'OG000'}, {'value': '791', 'groupId': 'OG001'}, {'value': '803', 'groupId': 'OG002'}, {'value': '790', 'groupId': 'OG003'}, {'value': '796', 'groupId': 'OG004'}, {'value': '784', 'groupId': 'OG005'}]}]}, {'title': 'MACE/ACM with Troponin value > cutoff', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}, {'title': 'No MACE/ACM (*Censored) with TnI value > cutoff', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}, {'value': '201', 'groupId': 'OG004'}, {'value': '188', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.00', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG000'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.31', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0011', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.09', 'ciLowerLimit': '1.59', 'ciUpperLimit': '5.95', 'pValueComment': 'Likelihood Ratio', 'groupDescription': 'Hazard Ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '12.76', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.65', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.65', 'ciLowerLimit': '2.21', 'ciUpperLimit': '6.05', 'pValueComment': 'Likelihood Ratio', 'groupDescription': 'Hazard Ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.17', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.07', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.54', 'ciLowerLimit': '1.84', 'ciUpperLimit': '6.87', 'pValueComment': 'Likelihood Ratio', 'groupDescription': 'Hazard Ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '12.83', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.66', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.68', 'ciLowerLimit': '2.25', 'ciUpperLimit': '6.05', 'pValueComment': 'Likelihood Ratio', 'groupDescription': 'Hazard Ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0020', 'groupIds': ['OG004'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '6.07', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0020', 'groupIds': ['OG004'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.09', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0050', 'groupIds': ['OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.95', 'ciLowerLimit': '1.41', 'ciUpperLimit': '6.05', 'pValueComment': 'Likelihood Ratio', 'groupDescription': 'Hazard Ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG005'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '12.15', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG005'], 'paramType': 'Proportion Percentage', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.57', 'estimateComment': 'Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff', 'groupDescription': 'Kaplan-Meier', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG005'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.55', 'ciLowerLimit': '2.08', 'ciUpperLimit': '6.03', 'pValueComment': 'Likelihood Ratio', 'groupDescription': 'Hazard Ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30-day and 90-day follow-up', 'description': 'Specimens were collected at 11 EDs from 1,101 subjects presenting to the ED with symptoms consistent with ACS. All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care. ARCHITECT STAT High Sensitive Troponin I results were generated from subject specimens and evaluated for use as an aid in the assessment of prognosis. Analyses used the first available troponin result from multiple serial draw time points. Subjects were assessed for risk of all cause mortality (ACM) and major adverse cardiac event (MACE) at 30 day and 90 day time points after ED discharge. MACE consisted of myocardial infarction, urgent revascularization, and cardiac death. Subjects were followed-up for subsequent events by medical record review and/or subject/caregiver contact. Any ACM and MACE that occurred during the ED visit and on the same day as ED discharge were not included in the analyses.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '30 Day and 90-day prognosis (Kaplan Meier analysis) and Hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) are summarized. \\*Censored is defined as the subject has not experienced ACM/MACE at the indicated follow-up time point.'}, {'type': 'PRIMARY', 'title': 'Clinical Performance- Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1066', 'groupId': 'OG000'}, {'value': '1088', 'groupId': 'OG001'}, {'value': '1029', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensitivity in K2 EDTA', 'description': 'Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).'}, {'id': 'OG001', 'title': 'Sensitivity in Lithium Heparin Separator', 'description': 'Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).'}, {'id': 'OG002', 'title': 'Sensitivity in Serum Separator', 'description': 'Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).'}], 'classes': [{'title': '% Sensitivity: 0-2 hours', 'categories': [{'measurements': [{'value': '84.44', 'groupId': 'OG000', 'lowerLimit': '75.28', 'upperLimit': '91.23'}, {'value': '85.26', 'groupId': 'OG001', 'lowerLimit': '76.51', 'upperLimit': '91.70'}, {'value': '87.32', 'groupId': 'OG002', 'lowerLimit': '77.30', 'upperLimit': '94.04'}]}]}, {'title': '% Sensitivity: 2-4 hours', 'categories': [{'measurements': [{'value': '92.21', 'groupId': 'OG000', 'lowerLimit': '83.81', 'upperLimit': '97.09'}, {'value': '91.86', 'groupId': 'OG001', 'lowerLimit': '83.95', 'upperLimit': '96.66'}, {'value': '92.00', 'groupId': 'OG002', 'lowerLimit': '83.40', 'upperLimit': '97.01'}]}]}, {'title': '% Sensitivity: 4-9 hours', 'categories': [{'measurements': [{'value': '93.90', 'groupId': 'OG000', 'lowerLimit': '86.34', 'upperLimit': '97.99'}, {'value': '94.95', 'groupId': 'OG001', 'lowerLimit': '88.61', 'upperLimit': '98.34'}, {'value': '93.15', 'groupId': 'OG002', 'lowerLimit': '84.74', 'upperLimit': '97.74'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percent Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '84.44', 'ciLowerLimit': '75.28', 'ciUpperLimit': '91.23', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Percent Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '83.81', 'paramValue': '92.21', 'ciLowerLimit': '83.81', 'ciUpperLimit': '97.09', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Percent Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.90', 'ciLowerLimit': '86.34', 'ciUpperLimit': '97.99', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percent Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '85.26', 'ciLowerLimit': '76.51', 'ciUpperLimit': '91.70', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percent Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '91.86', 'ciLowerLimit': '83.95', 'ciUpperLimit': '96.66', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percent Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '94.95', 'ciLowerLimit': '88.61', 'ciUpperLimit': '98.34', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Percent Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '87.32', 'ciLowerLimit': '77.30', 'ciUpperLimit': '94.04', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Percent Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '92.00', 'ciLowerLimit': '83.40', 'ciUpperLimit': '97.01', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Percent Sensitivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.15', 'ciLowerLimit': '84.74', 'ciUpperLimit': '97.74', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department', 'description': "The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Sensitivity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).", 'unitOfMeasure': 'percentage MI withTnI >cutoff vs all MI', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.'}, {'type': 'PRIMARY', 'title': 'Clinical Performance- Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1066', 'groupId': 'OG000'}, {'value': '1088', 'groupId': 'OG001'}, {'value': '1029', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Specificity in K2 EDTA', 'description': 'Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).'}, {'id': 'OG001', 'title': 'Specificity in Lithium Heparin Separator', 'description': 'Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).'}, {'id': 'OG002', 'title': 'Specificity in Serum Separator', 'description': 'Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).'}], 'classes': [{'title': '% Specificity: 0-2 hours', 'categories': [{'measurements': [{'value': '85.73', 'groupId': 'OG000', 'lowerLimit': '83.18', 'upperLimit': '88.03'}, {'value': '83.76', 'groupId': 'OG001', 'lowerLimit': '81.12', 'upperLimit': '86.17'}, {'value': '86.35', 'groupId': 'OG002', 'lowerLimit': '83.79', 'upperLimit': '88.63'}]}]}, {'title': '% Specificity: 2-4 hours', 'categories': [{'measurements': [{'value': '85.20', 'groupId': 'OG000', 'lowerLimit': '82.66', 'upperLimit': '87.50'}, {'value': '83.72', 'groupId': 'OG001', 'lowerLimit': '81.09', 'upperLimit': '86.11'}, {'value': '85.81', 'groupId': 'OG002', 'lowerLimit': '83.31', 'upperLimit': '88.07'}]}]}, {'title': '% Specificity: 4-9 hours', 'categories': [{'measurements': [{'value': '82.82', 'groupId': 'OG000', 'lowerLimit': '79.99', 'upperLimit': '85.40'}, {'value': '80.72', 'groupId': 'OG001', 'lowerLimit': '77.82', 'upperLimit': '83.39'}, {'value': '84.05', 'groupId': 'OG002', 'lowerLimit': '81.31', 'upperLimit': '86.54'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percent Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '85.73', 'ciLowerLimit': '83.18', 'ciUpperLimit': '88.03', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Percent Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '85.20', 'ciLowerLimit': '82.66', 'ciUpperLimit': '87.50', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Percent Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '82.82', 'ciLowerLimit': '79.99', 'ciUpperLimit': '85.40', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percent Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '83.76', 'ciLowerLimit': '81.12', 'ciUpperLimit': '86.17', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percent Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '83.72', 'ciLowerLimit': '81.09', 'ciUpperLimit': '86.11', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percent Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '80.72', 'ciLowerLimit': '77.82', 'ciUpperLimit': '83.39', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Percent Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '86.35', 'ciLowerLimit': '83.79', 'ciUpperLimit': '88.63', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Percent Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '85.81', 'ciLowerLimit': '83.31', 'ciUpperLimit': '88.07', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Percent Specificity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '84.05', 'ciLowerLimit': '81.31', 'ciUpperLimit': '86.54', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.', 'description': "The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Specificity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).", 'unitOfMeasure': '% nonMI with TnI </= cutoff vs all nonMI', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.'}, {'type': 'PRIMARY', 'title': 'Clinical Performance- Negative Predictive Value (NPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1066', 'groupId': 'OG000'}, {'value': '1088', 'groupId': 'OG001'}, {'value': '1029', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Predictive Value in K2 EDTA', 'description': 'Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).'}, {'id': 'OG001', 'title': 'Negative Predictive Value in Lithium Heparin Separator', 'description': 'Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).'}, {'id': 'OG002', 'title': 'Negative Predictive Value in Serum Separator', 'description': 'Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).'}], 'classes': [{'title': '% NPV: 0-2 hours', 'categories': [{'measurements': [{'value': '98.10', 'groupId': 'OG000', 'lowerLimit': '96.82', 'upperLimit': '98.95'}, {'value': '98.08', 'groupId': 'OG001', 'lowerLimit': '96.81', 'upperLimit': '98.95'}, {'value': '98.73', 'groupId': 'OG002', 'lowerLimit': '97.61', 'upperLimit': '99.42'}]}]}, {'title': '% NPV: 2-4 hours', 'categories': [{'measurements': [{'value': '99.19', 'groupId': 'OG000', 'lowerLimit': '98.25', 'upperLimit': '99.70'}, {'value': '99.05', 'groupId': 'OG001', 'lowerLimit': '98.05', 'upperLimit': '99.62'}, {'value': '99.20', 'groupId': 'OG002', 'lowerLimit': '98.27', 'upperLimit': '99.71'}]}]}, {'title': '% NPV: 4-9 hours', 'categories': [{'measurements': [{'value': '99.23', 'groupId': 'OG000', 'lowerLimit': '98.22', 'upperLimit': '99.75'}, {'value': '99.24', 'groupId': 'OG001', 'lowerLimit': '98.22', 'upperLimit': '99.75'}, {'value': '99.25', 'groupId': 'OG002', 'lowerLimit': '98.26', 'upperLimit': '99.76'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Negative Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.10', 'ciLowerLimit': '96.82', 'ciUpperLimit': '98.95', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Negative Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.19', 'ciLowerLimit': '98.25', 'ciUpperLimit': '99.70', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Negative Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.23', 'ciLowerLimit': '98.22', 'ciUpperLimit': '99.75', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Negative Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.08', 'ciLowerLimit': '96.81', 'ciUpperLimit': '98.95', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Negative Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.05', 'ciLowerLimit': '98.05', 'ciUpperLimit': '99.62', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Negative Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.24', 'ciLowerLimit': '98.22', 'ciUpperLimit': '99.75', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Negative Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.73', 'ciLowerLimit': '97.61', 'ciUpperLimit': '99.42', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Negative Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.20', 'ciLowerLimit': '98.27', 'ciUpperLimit': '99.71', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Negative Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.25', 'ciLowerLimit': '98.26', 'ciUpperLimit': '99.76', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.', 'description': "The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Negative Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).", 'unitOfMeasure': '%nonMI,TnI</=cutoff vs all TnI</=cutoff', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.'}, {'type': 'PRIMARY', 'title': 'Clinical Performance- Positive Predictive Value (PPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1066', 'groupId': 'OG000'}, {'value': '1088', 'groupId': 'OG001'}, {'value': '1029', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Predictive Value in K2 EDTA', 'description': 'Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).'}, {'id': 'OG001', 'title': 'Positive Predictive Value in Lithium Heparin Separator', 'description': 'Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).'}, {'id': 'OG002', 'title': 'Positive Predictive Value in Serum Separator', 'description': 'Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).'}], 'classes': [{'title': '% PPV: 0-2 hours', 'categories': [{'measurements': [{'value': '38.78', 'groupId': 'OG000', 'lowerLimit': '31.92', 'upperLimit': '45.98'}, {'value': '36.82', 'groupId': 'OG001', 'lowerLimit': '30.43', 'upperLimit': '43.56'}, {'value': '35.84', 'groupId': 'OG002', 'lowerLimit': '28.70', 'upperLimit': '43.47'}]}]}, {'title': '% PPV: 2-4 hours', 'categories': [{'measurements': [{'value': '35.68', 'groupId': 'OG000', 'lowerLimit': '29.03', 'upperLimit': '42.76'}, {'value': '35.75', 'groupId': 'OG001', 'lowerLimit': '29.43', 'upperLimit': '42.45'}, {'value': '35.94', 'groupId': 'OG002', 'lowerLimit': '29.16', 'upperLimit': '43.16'}]}]}, {'title': '% PPV: 4-9 hours', 'categories': [{'measurements': [{'value': '36.49', 'groupId': 'OG000', 'lowerLimit': '29.99', 'upperLimit': '43.38'}, {'value': '37.75', 'groupId': 'OG001', 'lowerLimit': '31.71', 'upperLimit': '44.09'}, {'value': '35.05', 'groupId': 'OG002', 'lowerLimit': '28.36', 'upperLimit': '42.21'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Positive Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.78', 'ciLowerLimit': '31.92', 'ciUpperLimit': '45.98', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Positive Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.68', 'ciLowerLimit': '29.03', 'ciUpperLimit': '42.76', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Positive Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.49', 'ciLowerLimit': '29.99', 'ciUpperLimit': '43.38', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Positive Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.82', 'ciLowerLimit': '30.43', 'ciUpperLimit': '43.56', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Positive Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.75', 'ciLowerLimit': '29.43', 'ciUpperLimit': '42.45', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Positive Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.75', 'ciLowerLimit': '31.71', 'ciUpperLimit': '44.09', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Positive Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.84', 'ciLowerLimit': '28.70', 'ciUpperLimit': '43.47', 'groupDescription': 'Time point: 0-2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Positive Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.94', 'ciLowerLimit': '29.16', 'ciUpperLimit': '43.16', 'groupDescription': 'Time point: 2-4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Positive Predictive Value', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.05', 'ciLowerLimit': '28.36', 'ciUpperLimit': '42.21', 'groupDescription': 'Time point: 4-9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.', 'description': "The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Positive Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).", 'unitOfMeasure': '%MI,TnI >cutoff vs all TnI > cutoff', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ARCHITECT STAT High Sensitive Troponin I Assay Testing', 'description': 'All subjects will have their blood tested by the investigational Troponin I assay.\n\nARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.\n\nResults obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.\n\nTroponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ARCHITECT STAT High Sensitive Troponin I Assay Testing', 'description': 'All subjects will have their blood tested by the investigational ARCHITECT STAT High Sensitive Troponin I assay. Specimens were collected at 11 emergency departments from 1,101 subjects presenting to the emergency department with symptoms consistent with acute coronary syndrome (ACS). All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '746', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '355', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '482', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '619', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '692', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Observed Myocardial Infarction Prevalence', 'classes': [{'title': 'Number Participants with Myocardial Infarction', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}]}]}, {'title': 'Number Participants without Myocardial Infarction', 'categories': [{'measurements': [{'value': '971', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2012-05-21', 'resultsFirstSubmitDate': '2014-12-03', 'studyFirstSubmitQcDate': '2012-05-29', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-04', 'studyFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Performance - Area Under the Curve', 'timeFrame': 'Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department', 'description': "The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator)."}, {'measure': 'Clinical Performance- Sensitivity', 'timeFrame': 'Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department', 'description': "The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Sensitivity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator)."}, {'measure': 'Clinical Performance- Specificity', 'timeFrame': 'Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.', 'description': "The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Specificity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator)."}, {'measure': 'Clinical Performance- Negative Predictive Value (NPV)', 'timeFrame': 'Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.', 'description': "The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Negative Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator)."}, {'measure': 'Clinical Performance- Positive Predictive Value (PPV)', 'timeFrame': 'Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.', 'description': "The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Positive Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator)."}], 'secondaryOutcomes': [{'measure': 'Prognosis', 'timeFrame': '30-day and 90-day follow-up', 'description': 'Specimens were collected at 11 EDs from 1,101 subjects presenting to the ED with symptoms consistent with ACS. All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care. ARCHITECT STAT High Sensitive Troponin I results were generated from subject specimens and evaluated for use as an aid in the assessment of prognosis. Analyses used the first available troponin result from multiple serial draw time points. Subjects were assessed for risk of all cause mortality (ACM) and major adverse cardiac event (MACE) at 30 day and 90 day time points after ED discharge. MACE consisted of myocardial infarction, urgent revascularization, and cardiac death. Subjects were followed-up for subsequent events by medical record review and/or subject/caregiver contact. Any ACM and MACE that occurred during the ED visit and on the same day as ED discharge were not included in the analyses.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome', 'Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, Troponin I, in an intended use population. Blood specimens will be tested using the new investigational test that detects the level of Troponin I. Results will be compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.', 'detailedDescription': 'The purpose of the cardiac biomarker Troponin I is to aid in the diagnosis of myocardial infarction.The assay is also intended to assist in the prognosis relative risk to all cause mortality (ACM) and major adverse cardiac events (MACE) consisting of myocardial infarction, revascularization, and cardiac death in patients who present with symptoms suggestive of acute coronary syndrome (ACS) without a diagnosis of myocardial infarction.\n\nAll specimens were collected under a separate specimen collection protocol (Protocol No, 7B5-02-09A01-01: Clinical Specimen Procurement for Biomarker Evaluation of Suspected ACS). The specimens that will be tested include approximately 8300 specimens collected from 1101 subjects presenting to Emergency Departments with signs and symptoms of Acute Coronary Syndrome and will be provided to the clinical sites performing investigational Troponin I testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.\n* an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS).\n* greater than 18 years of age.\n* not known to be pregnant.\n* agreement to the follow-up required by the study.\n\nExclusion Criteria:\n\n* prior participation in this study.\n* require dialysis for end stage renal disease.\n* history of a previous heart transplant.\n* coexisting disorder associated with limited life expectancy.\n* currently participating in another investigational device or drug study.'}, 'identificationModule': {'nctId': 'NCT01608100', 'briefTitle': 'Evaluation of a New Cardiac Biomarker Assay', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Diagnostics Division'}, 'officialTitle': 'Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay', 'orgStudyIdInfo': {'id': '7B5-02-10A01-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARCHITECT STAT High Sensitive Troponin I Assay testing', 'description': 'All subjects will have their blood tested by the investigational ARCHITECT STAT High SensitiveTroponin I assay.', 'interventionNames': ['Device: ARCHITECT STAT High Sensitive Troponin I Assay']}], 'interventions': [{'name': 'ARCHITECT STAT High Sensitive Troponin I Assay', 'type': 'DEVICE', 'description': 'Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay. Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the timeframes (30 days and 90 days) after the Emergency Department visit.\n\nTroponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit.', 'armGroupLabels': ['ARCHITECT STAT High Sensitive Troponin I Assay testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Chandler Regional Medical Center', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Emergency Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '33309', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Nationwide Laboratory Services', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '11777', 'city': 'Port Jefferson', 'state': 'New York', 'country': 'United States', 'facility': 'John T Mather Memorial Hospital', 'geoPoint': {'lat': 40.94649, 'lon': -73.06927}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania State University- Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78752', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Hospital Physicians in Clinical Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77802', 'city': 'Bryan', 'state': 'Texas', 'country': 'United States', 'facility': 'Hospital Physicians in Clinical Research', 'geoPoint': {'lat': 30.67436, 'lon': -96.36996}}, {'zip': '22908-2877', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Dept of Emergency Medicine University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98225', 'city': 'Bellingham', 'state': 'Washington', 'country': 'United States', 'facility': 'St Joseph Hospital', 'geoPoint': {'lat': 48.75955, 'lon': -122.48822}}], 'overallOfficials': [{'name': 'Fred S Apple, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hennepin Healthcare Research Institute'}, {'name': 'Frank Peacock, MD', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Diagnostics Division', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}