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

Myocardial Infarction Clinical Trial

— UTROPIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060760
• Other study ID #: HSR 13-3690
• Status: Completed
• Start date: February 2014
• Est. completion date: December 2021

Study information

• Verified date: October 2022
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1927
• Est. completion date: December 2021
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Hypersensitivity
• Infarction
• Myocardial Infarction
• Syndrome
• Troponin

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	Abbott Diagnostics Division, Hennepin County Medical Center, Minneapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resource utilization	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
Other	Type 2 AMI Physiologic Assessment	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
Other	Troponin in Angiography	cTnI concentration changes will be analyzed among patients who underwent coronary angiography	Up to 6 months after last enrollment
Primary	Incidence of Acute Myocardial Infarction	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	In- hospital mortality		Up to 6 months after last enrollment
Secondary	180 day mortality		Up to 6 months after last enrollment
Secondary	Repeat Cardiac hospitalization		Up to 6 months after last enrollment
Secondary	Time to repeat cardiac hospitalization		Up to 6 months after last enrollment
Secondary	ACS Diagnosis		Up to 6 months after last enrollment
Secondary	Repeat revascularization (bypass surgery versus percutaneous revascularization)		Up to 6 months after last enrollment
Secondary	Emergency encounter for chest pain		Up to 6 months after last enrollment
Secondary	New diagnosis of Congestive Heart Failure		Up to 6 months after last enrollment