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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Minneapolis Medical Research Foundation
Sponsor:
Collaborators:
Abbott Diagnostics Division
Hennepin County Medical Center, Minneapolis
Information provided by (Responsible Party):
Fred Apple, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT02060760
First received: February 5, 2014
Last updated: April 25, 2014
Last verified: April 2014
  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 Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • Incidence of Acute Myocardial Infarction [ Time Frame: Up to 6 months after last enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 180 day mortality [ Time Frame: Up to 6 months after last enrollment ] [ Designated as safety issue: No ]
  • Repeat Cardiac hospitalization [ Time Frame: Up to 6 months after last enrollment ] [ Designated as safety issue: No ]
  • Time to repeat cardiac hospitalization [ Time Frame: Up to 6 months after last enrollment ] [ Designated as safety issue: No ]
  • ACS Diagnosis [ Time Frame: Up to 6 months after last enrollment ] [ Designated as safety issue: No ]
  • Repeat revascularization (bypass surgery versus percutaneous revascularization) [ Time Frame: Up to 6 months after last enrollment ] [ Designated as safety issue: No ]
  • Emergency encounter for chest pain [ Time Frame: Up to 6 months after last enrollment ] [ Designated as safety issue: No ]
  • New diagnosis of Congestive Heart Failure [ Time Frame: Up to 6 months after last enrollment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Resource utilization [ Time Frame: Up to 6 months after last enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060760

Contacts
Contact: Karen Schulz, DC 612 -873-6893 kschulz@mmrf.org
Contact: MaryAnn Murakami 612- 873-6891 Maryann.Murakami@hcmed.org

Locations
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Karen Schulz    612-873-6893    kschulz@mmrf.org   
Sub-Investigator: Yader Sandoval, MD         
Sub-Investigator: Sarah E Thordsen, MD         
Sub-Investigator: Stephen W Smith, MD         
Sub-Investigator: Karen Schulz, DC         
Sub-Investigator: MaryAnn M Murakami         
Sub-Investigator: Sara Love, PhD         
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

No publications provided

Responsible Party: Fred Apple, PhD, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02060760     History of Changes
Other Study ID Numbers: HSR 13-3690
Study First Received: February 5, 2014
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014