An observational study in Acute Coronary Syndrome, Myocardial Infarction and Troponin, sponsored by Hennepin Healthcare Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-12.
Sponsored by Hennepin Healthcare Research Institute · Observational
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 1,927 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Hennepin Healthcare Research Institute is the lead sponsor of 69 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients presenting to Hennepin County Medical Center through the emergency department within the defined study period will be considered for inclusion.
Exclusion Criteria:
At least two cTnI data points available (including baseline) with blood samples available for hs-cTnI testing. No intervention.
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.
Time frame: Up to 6 months after last enrollment
In- hospital mortality
Time frame: Up to 6 months after last enrollment
180 day mortality
Time frame: Up to 6 months after last enrollment
Repeat Cardiac hospitalization
Time frame: Up to 6 months after last enrollment
Time to repeat cardiac hospitalization
Time frame: Up to 6 months after last enrollment
ACS Diagnosis
Time frame: Up to 6 months after last enrollment
Repeat revascularization (bypass surgery versus percutaneous revascularization)
Time frame: Up to 6 months after last enrollment
Emergency encounter for chest pain
Time frame: Up to 6 months after last enrollment
New diagnosis of Congestive Heart Failure
Time frame: Up to 6 months after last enrollment
Resource utilization
Resource utilization rates including medications (sorted by class), cardiac evaluation procedures(e.g. echocardiogram, angiography, interventions) and speciality consultations will be assessed.
Time frame: Up to 6 months after last enrollment
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
Time frame: Up to 6 months after last enrollment
Troponin in Angiography
cTnI concentration changes will be analyzed among patients who underwent coronary angiography
Time frame: Up to 6 months after last enrollment
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Hennepin Healthcare Research Institute