Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-28 @ 8:43 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:
Hennepin Healthcare Research Institute
Organization:
Study Overview
Official Title:
Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UTROPIA
Brief Summary:
Hypothesis: High sensitivity cTnI assays will have improved diagnostic accuracy for type 1 MI compared to contemporary cTnI assays.
The 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).
The 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).
Investigators 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.
Lastly, 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.
The 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).
The 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).
Investigators 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.
Lastly, 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: