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

NCT02060760 | Completed

• 1 other identifier: HSR 13-3690
• Study Type: observational
• Target: 1,927
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Troponin

Keywords

Prospective cohort study; Diagnostic accuracy; High sensitivity versus contemporary troponin I assay; Gender; Renal Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Time to repeat cardiac hospitalization

  Up to 6 months after last enrollment

• ACS Diagnosis

  Up to 6 months after last enrollment

Other Outcomes (3)

• Resource utilization

  Up to 6 months after last enrollment

• Type 2 AMI Physiologic Assessment

  Up to 6 months after last enrollment

• Troponin in Angiography

  Up to 6 months after last enrollment

Study Arms (1)

UTROPIA study cohort

At least two cTnI data points available (including baseline) with blood samples available for hs-cTnI testing. No intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Two or more cTnI values ordered for any clinical indication with specimen available for hs cTnI assay
• years of age or older
• EKG done on admission / presentation
• Agree to research disclosure

You may not qualify if:

• Admission through any venue other an emergency department
• Repeat admission for the same patient, only primary admission will be assessed
• Pregnancy

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• Abbott Diagnostics Division: collaborator
• Hennepin County Medical Center, Minneapolis: collaborator

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (7)

• Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S; ARTEMIS study group. Personalized diagnosis in suspected myocardial infarction. Clin Res Cardiol. 2023 Sep;112(9):1288-1301. doi: 10.1007/s00392-023-02206-3. Epub 2023 May 2.

  PMID: 37131096 DERIVED

• 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.

  PMID: 30933618 DERIVED

• 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.

  PMID: 30849383 DERIVED

• 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.

  PMID: 30419227 DERIVED

• 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.

  PMID: 29079658 DERIVED

• 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.

  PMID: 28701316 DERIVED

• 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.

  PMID: 27811203 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Excess blood is biobanked as EDTA-plasma and heparin samples after being used for the clinical cTnI assay according to IRB approval HSR # 07-2854

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Coitus

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Sexual Behavior; Behavior

Study Officials

• Fred Apple, PhD

  Minneapolis Medical Research Foundation and Hennepin County Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 180 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 12, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2021
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

US (1)