Acute Coronary Syndrome, Myocardial Infarction, Troponin
Conditions
Keywords
Prospective cohort study, Diagnostic accuracy, High sensitivity versus contemporary troponin I assay, Gender, Renal Function
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.
Interventions
None listed
Sponsors
Abbott Diagnostics Division
Hennepin County Medical Center, Minneapolis
Hennepin Healthcare Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time to repeat cardiac hospitalization | 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 |
| 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 |
| ACS Diagnosis | Up to 6 months after last enrollment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Troponin in Angiography | Up to 6 months after last enrollment | cTnI concentration changes will be analyzed among patients who underwent coronary angiography |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed