Clinical trial NCT02060760: Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes
Official title: Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Troponin
Keywords: Prospective cohort study
Diagnostic accuracy
High sensitivity versus contemporary troponin I assay
Gender
Renal Function
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Abbott Diagnostics Division
name: Hennepin County Medical Center, Minneapolis
First posted: 2014-02-12
Enrollment: 1927
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to Hennepin County Medical Center through the emergency department within the defined study period will be considered for inclusion.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Acute Myocardial Infarction
timeFrame: Up to 6 months after last enrollment
Secondary outcomes:
measure: In- hospital mortality
timeFrame: Up to 6 months after last enrollment
measure: 180 day mortality
timeFrame: Up to 6 months after last enrollment
measure: Repeat Cardiac hospitalization
timeFrame: Up to 6 months after last enrollment
measure: Time to repeat cardiac hospitalization
timeFrame: Up to 6 months after last enrollment
measure: ACS Diagnosis
timeFrame: Up to 6 months after last enrollment
measure: Repeat revascularization (bypass surgery versus percutaneous revascularization)
timeFrame: Up to 6 months after last enrollment
measure: Emergency encounter for chest pain
timeFrame: Up to 6 months after last enrollment
measure: New diagnosis of Congestive Heart Failure
timeFrame: Up to 6 months after last enrollment
Other outcomes:
measure: Resource utilization
timeFrame: Up to 6 months after last enrollment
measure: Type 2 AMI Physiologic Assessment
timeFrame: Up to 6 months after last enrollment
measure: Troponin in Angiography
timeFrame: Up to 6 months after last enrollment
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis Medical Research Foundation and Hennepin County Medical Center
name: Fred Apple, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandoval Y, Smith SW, Sexter A, Gunsolus IL, Schulz K, Apple FS. Clinical Features and Outcomes of Emergency Department Patients With High-Sensitivity Cardiac Troponin I Concentrations Within Sex-Specific Reference Intervals. Circulation. 2019 Apr 2;139(14):1753-1755. doi: 10.1161/CIRCULATIONAHA.118.038284. No abstract available.
citation: Sandoval Y, Gunsolus IL, Smith SW, Sexter A, Thordsen SE, Carlson MD, Johnson BK, Bruen CA, Dodd KW, Driver BE, Jacoby K, Love SA, Moore JC, Scott NL, Schulz K, Apple FS. Appropriateness of Cardiac Troponin Testing: Insights from the Use of TROPonin In Acute coronary syndromes (UTROPIA) Study. Am J Med. 2019 Jul;132(7):869-874. doi: 10.1016/j.amjmed.2019.01.043. Epub 2019 Mar 5.
citation: Cediel G, Sandoval Y, Sexter A, Carrasquer A, Gonzalez-Del-Hoyo M, Bonet G, Boque C, Schulz K, Smith SW, Bayes-Genis A, Apple FS, Bardaji A. Risk Estimation in Type 2 Myocardial Infarction and Myocardial Injury: The TARRACO Risk Score. Am J Med. 2019 Feb;132(2):217-226. doi: 10.1016/j.amjmed.2018.10.022. Epub 2018 Nov 9.
citation: Gunsolus I, Sandoval Y, Smith SW, Sexter A, Schulz K, Herzog CA, Apple FS. Renal Dysfunction Influences the Diagnostic and Prognostic Performance of High-Sensitivity Cardiac Troponin I. J Am Soc Nephrol. 2018 Feb;29(2):636-643. doi: 10.1681/ASN.2017030341. Epub 2017 Oct 27.
citation: Sandoval Y, Smith SW, Thordsen SE, Bruen CA, Carlson MD, Dodd KW, Driver BE, Jacoby K, Johnson BK, Love SA, Moore JC, Sexter A, Schulz K, Scott NL, Nicholson J, Apple FS. Diagnostic Performance of High Sensitivity Compared with Contemporary Cardiac Troponin I for the Diagnosis of Acute Myocardial Infarction. Clin Chem. 2017 Oct;63(10):1594-1604. doi: 10.1373/clinchem.2017.272930. Epub 2017 Jul 12.
citation: Sandoval Y, Smith SW, Shah AS, Anand A, Chapman AR, Love SA, Schulz K, Cao J, Mills NL, Apple FS. Rapid Rule-Out of Acute Myocardial Injury Using a Single High-Sensitivity Cardiac Troponin I Measurement. Clin Chem. 2017 Jan;63(1):369-376. doi: 10.1373/clinchem.2016.264523. Epub 2016 Nov 3.