Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes

Completed

• Conditions: Acute Coronary Syndrome; Myocardial Infarction; Troponin

• Registration Number: NCT02060760
• Lead Sponsor: Hennepin Healthcare Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-12
• Primary Completion: 2016-06
• Study Completion: 2021-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1927

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Acute Myocardial Infarction	Up to 6 months after last enrollment	Adjudicated diagnosis of acute myocardial infarction (AMI) to systematize the potentially earlier (0,3,6h) detection of AMI using the Abbott hs cTnI assay.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States