Overview

This trial is active, not recruiting.

Conditions acute coronary syndrome, myocardial infarction, troponin
Sponsor Minneapolis Medical Research Foundation
Collaborator Abbott Diagnostics Division
Start date February 2014
End date June 2016
Trial size 2000 participants
Trial identifier NCT02060760, HSR 13-3690

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
At least two cTnI data points available (including baseline) with blood samples available for hs-cTnI testing. No intervention.

Primary Outcomes

Measure
Incidence of Acute Myocardial Infarction
time frame: Up to 6 months after last enrollment

Secondary Outcomes

Measure
In- hospital mortality
time frame: Up to 6 months after last enrollment
180 day mortality
time frame: Up to 6 months after last enrollment
Repeat Cardiac hospitalization
time frame: Up to 6 months after last enrollment
Time to repeat cardiac hospitalization
time frame: Up to 6 months after last enrollment
ACS Diagnosis
time frame: Up to 6 months after last enrollment
Repeat revascularization (bypass surgery versus percutaneous revascularization)
time frame: Up to 6 months after last enrollment
Emergency encounter for chest pain
time frame: Up to 6 months after last enrollment
New diagnosis of Congestive Heart Failure
time frame: Up to 6 months after last enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes
Principal investigator Fred Apple, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Minneapolis Medical Research Foundation.