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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02060760
Other study ID # HSR 13-3690
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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