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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02060760
First Posted: February 12, 2014
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Abbott Diagnostics Division
Hennepin County Medical Center, Minneapolis
Information provided by (Responsible Party):
Fred Apple, Minneapolis Medical Research Foundation
  Purpose

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.


Condition
Acute Coronary Syndrome Myocardial Infarction Troponin

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 180 Days
Official Title: Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes

Resource links provided by NLM:


Further study details as provided by Fred Apple, Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • In- hospital mortality [ Time Frame: Up to 6 months after last enrollment ]
  • 180 day mortality [ Time Frame: Up to 6 months after last enrollment ]
  • Repeat Cardiac hospitalization [ Time Frame: Up to 6 months after last enrollment ]
  • Time to repeat cardiac hospitalization [ Time Frame: Up to 6 months after last enrollment ]
  • ACS Diagnosis [ Time Frame: Up to 6 months after last enrollment ]
  • Repeat revascularization (bypass surgery versus percutaneous revascularization) [ Time Frame: Up to 6 months after last enrollment ]
  • Emergency encounter for chest pain [ Time Frame: Up to 6 months after last enrollment ]
  • New diagnosis of Congestive Heart Failure [ Time Frame: Up to 6 months after last enrollment ]

Other Outcome Measures:
  • 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.

  • 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

  • Troponin in Angiography [ Time Frame: Up to 6 months after last enrollment ]
    cTnI concentration changes will be analyzed among patients who underwent coronary angiography


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

Estimated Enrollment: 2000
Study Start Date: February 2014
Estimated Study Completion Date: December 2019
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
UTROPIA study cohort
At least two cTnI data points available (including baseline) with blood samples available for hs-cTnI testing. No intervention.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060760


Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Abbott Diagnostics Division
Hennepin County Medical Center, Minneapolis
Investigators
Principal Investigator: Fred Apple, PhD Minneapolis Medical Research Foundation and Hennepin County Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fred Apple, PhD, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02060760     History of Changes
Other Study ID Numbers: HSR 13-3690
First Submitted: February 5, 2014
First Posted: February 12, 2014
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Fred Apple, Minneapolis Medical Research Foundation:
Prospective cohort study
Diagnostic accuracy
High sensitivity versus contemporary troponin I assay
Gender
Renal Function

Additional relevant MeSH terms:
Syndrome
Infarction
Myocardial Infarction
Hypersensitivity
Acute Coronary Syndrome
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Immune System Diseases