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

October 10, 2022 updated by: Fred Apple, Hennepin Healthcare Research Institute

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1927

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients presenting to Hennepin County Medical Center through the emergency department within the defined study period will be considered for inclusion.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
UTROPIA study cohort
At least two cTnI data points available (including baseline) with blood samples available for hs-cTnI testing. No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Acute Myocardial Infarction
Time Frame: 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.
Up to 6 months after last enrollment

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resource utilization
Time Frame: Up to 6 months after last enrollment
Resource utilization rates including medications (sorted by class), cardiac evaluation procedures(e.g. echocardiogram, angiography, interventions) and speciality consultations will be assessed.
Up to 6 months after last enrollment
Type 2 AMI Physiologic Assessment
Time Frame: Up to 6 months after last enrollment

Expert adjudication of the cause of decreased oxygen supply or increased myocardial oxygen demand resulting in positive cTnI measured by both hs-cTnI and contemporary cTnI assays based on pre-specified subtypes, including:

  • Decreased Supply
  • Increased Demand
  • Multifactorial of Indeterminate myocardial injury
Up to 6 months after last enrollment
Troponin in Angiography
Time Frame: Up to 6 months after last enrollment
cTnI concentration changes will be analyzed among patients who underwent coronary angiography
Up to 6 months after last enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Collaborators

Abbott Diagnostics Division
Hennepin County Medical Center, Minneapolis

Investigators

  • Principal Investigator: Fred Apple, PhD, Minneapolis Medical Research Foundation and Hennepin County Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR 13-3690

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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