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NCT02060760 · ClinicalTrials.gov registry record
Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes
A clinical trial, sponsored by Hennepin Healthcare Research Institute.
- Completed
- Registry status
- 1,927
- Enrollment target
NCT02060760: Completed study, sponsored by Hennepin Healthcare Research Institute.
NCT02060760 is a clinical trial that has completed, run by Hennepin Healthcare Research Institute. The registered enrollment target is 1,927 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02060760 has completed, sponsored by Hennepin Healthcare Research Institute.
- COMPLETED
- Registry status
- 1,927 participants
- Enrollment target
Study 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.
Primary Outcome
Adjudicated diagnosis of acute myocardial infarction (AMI) to systematize the potentially earlier (0,3,6h) detection of AMI using the Abbott hs cTnI assay.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,927 participants |
| Start Date | 2014-02 |
| Est. Completion | 2021-12 |
What the finished NCT02060760 record still lists
NCT02060760 is an observational study that tracks outcomes without assigning an intervention. Its 1,927 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT02060760 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02060760 about?
NCT02060760 is a clinical study titled "Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes". 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 t...
What is the current status of trial NCT02060760?
This trial is currently completed. The enrollment target is 1,927 participants. The study started on 2014-02. Estimated completion is 2021-12.
Who is sponsoring clinical trial NCT02060760?
This trial is sponsored by Hennepin Healthcare Research Institute, which has 63 total clinical trials registered on ClinicalTrials.gov.
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