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

Sponsor

Hennepin Healthcare Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02060760

Collaborator

Abbott Diagnostics Division (Industry), Hennepin County Medical Center, Minneapolis (Other)

2,000

Enrollment

Location

Duration (Months)

21.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Myocardial Infarction Troponin

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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]
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]
New diagnosis of Congestive Heart Failure [Up to 6 months after last enrollment]

Other Outcome Measures

Resource utilization [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.
Type 2 AMI Physiologic Assessment [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
Troponin in Angiography [Up to 6 months after last enrollment]
cTnI concentration changes will be analyzed among patients who underwent coronary angiography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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