COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial
NCT ID: NCT03214029
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2000 participants
OBSERVATIONAL
2017-11-06
2025-12-31
Brief Summary
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Detailed Description
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Study objective: Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
Null Hypothesis: hs-cTnI and or hs-cTnT assays will offer comparable diagnostic performance for acute myocardial injury and acute myocardial
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study population
Prospective, observational cohort study of consecutives patients (goal, 2000 patients over 5 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.
Cardiac troponin testing
Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.
Interventions
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Cardiac troponin testing
Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.
Eligibility Criteria
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Inclusion Criteria
2. Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial cTnI measurement.
3. At least one 12-lead electrocardiogram
Exclusion Criteria
2. Trauma related admission
3. Cardiac arrest
4. Decline to participate
5. Did not present through the ED
6. Transferred from an outside hospital
18 Years
ALL
No
Sponsors
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Abbott Diagnostics Division
INDUSTRY
Hennepin County Medical Center, Minneapolis
OTHER
Hennepin Healthcare Research Institute
OTHER
Responsible Party
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Principal Investigators
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Fred S Apple, PhD
Role: PRINCIPAL_INVESTIGATOR
Hennepin County Medical Center and Minneapolis Medical Research Foundation
Locations
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Hennepin County Medical Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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CONTRAST
Identifier Type: -
Identifier Source: org_study_id
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