Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/13/2019 |
| Start Date: | February 2014 |
| End Date: | December 2019 |
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.
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.
Inclusion Criteria:
- Two or more cTnI values ordered for any clinical indication with specimen available
for hs cTnI assay
- 18 years of age or older
- EKG done on admission / presentation
- Agree to research disclosure
Exclusion Criteria:
- Admission through any venue other an emergency department
- Repeat admission for the same patient, only primary admission will be assessed
- Pregnancy
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