AzTrials
AzTrials

Acute Coronary SyndromeUTROPIANCT02060760

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

An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Hennepin Healthcare Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,927 participants
Where
1 siteUnited States
Study dates
Feb 2014to Dec 2021
How long will I take part?
180 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients presenting to Hennepin County Medical Center through the emergency department within the defined study period will be considered for inclusion.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

Other trials in United States

About this study

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).

Read more

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.

Keywords
Prospective cohort study, Diagnostic accuracy, High sensitivity versus contemporary troponin I assay, Gender, Renal Function
Medical subject headings
Acute Coronary Syndrome, Myocardial Infarction, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02060760
Study groupRoleWhat they receive
UTROPIA study cohortAt least two cTnI data points available (including baseline) with blood samples available for hs-cTnI testing. No intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 6 months after last enrollment

Secondary outcomes (8)

  1. In- hospital mortality

    Measured: Up to 6 months after last enrollment

  2. 180 day mortality

    Measured: Up to 6 months after last enrollment

  3. Repeat Cardiac hospitalization

    Measured: Up to 6 months after last enrollment

  4. Time to repeat cardiac hospitalization

    Measured: Up to 6 months after last enrollment

  5. ACS Diagnosis

    Measured: Up to 6 months after last enrollment

  6. Repeat revascularization (bypass surgery versus percutaneous revascularization)

    Measured: Up to 6 months after last enrollment

  7. Emergency encounter for chest pain

    Measured: Up to 6 months after last enrollment

  8. New diagnosis of Congestive Heart Failure

    Measured: Up to 6 months after last enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2016
  4. Study completionDec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,927 participants (actual)
Target duration
180 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT02060760
Sponsor's protocol ID
HSR 13-3690
Acronym
UTROPIA
Status last verified
Oct 2022
First submitted
5 Feb 2014
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37131096

  • 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.

    PubMed 30933618

  • 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.

    PubMed 30849383

  • 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.

    PubMed 30419227

  • 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.

    PubMed 29079658

  • 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.

    PubMed 28701316

  • 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.

    PubMed 27811203

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Hennepin Healthcare Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Acute Myocardial Infarction (time frame: Up to 6 months after last enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02060760, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in