Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes (UTROPIA)
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|ClinicalTrials.gov Identifier: NCT02060760|
Recruitment Status : Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : August 30, 2017
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 or disease|
|Acute Coronary Syndrome Myocardial Infarction Troponin|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||180 Days|
|Official Title:||Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2019|
UTROPIA study cohort
At least two cTnI data points available (including baseline) with blood samples available for hs-cTnI testing. No intervention.
- 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.
- 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 ]
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060760
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Principal Investigator:||Fred Apple, PhD||Minneapolis Medical Research Foundation and Hennepin County Medical Center|