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OpenTrials
Completed

NCT Number: NCT02060760

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

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.

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Key information

Conditions

Acute Coronary Syndrome Behavior Cardiovascular Diseases Coitus Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior Troponin Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Acute Myocardial Infarction

    Time frame: 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 outcomes

  1. In- hospital mortality

    Time frame: Up to 6 months after last enrollment

  2. 180 day mortality

    Time frame: Up to 6 months after last enrollment

  3. Repeat Cardiac hospitalization

    Time frame: Up to 6 months after last enrollment

  4. Time to repeat cardiac hospitalization

    Time frame: Up to 6 months after last enrollment

  5. ACS Diagnosis

    Time frame: Up to 6 months after last enrollment

  6. Repeat revascularization (bypass surgery versus percutaneous revascularization)

    Time frame: Up to 6 months after last enrollment

  7. Emergency encounter for chest pain

    Time frame: Up to 6 months after last enrollment

  8. New diagnosis of Congestive Heart Failure

    Time frame: Up to 6 months after last enrollment

Other outcomes

  1. Resource utilization

    Time frame: 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.

  2. Type 2 AMI Physiologic Assessment

    Time frame: 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

  3. Troponin in Angiography

    Time frame: Up to 6 months after last enrollment

    cTnI concentration changes will be analyzed among patients who underwent coronary angiography

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • Abbott Diagnostics Division
  • Hennepin County Medical Center, Minneapolis

Registry information

Acronym: UTROPIA

Important dates

Study start
2014
Primary completion
2016
Study completion
2021
First posted
Feb 12, 2014
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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