Clinical trial NCT03214029: COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial
Official title: COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myocardial Infarction
Acute Coronary Syndrome
Keywords: troponin
high-sensitivity cardiac troponin
acute myocardial infarction
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Abbott Diagnostics Division
name: Hennepin County Medical Center, Minneapolis
First posted: 2017-07-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive 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.

Brief summary: 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.

Detailed description: Background: Comparative studies addressing the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking.

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

Eligibility criteria: Inclusion Criteria:

1. Adult, defined as subject 18 years of age or older
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:

1. Currently pregnant
2. Trauma related admission
3. Cardiac arrest
4. Decline to participate
5. Did not present through the ED
6. Transferred from an outside hospital

Primary outcomes:
measure: Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.
timeFrame: on admission
Secondary outcomes:
measure: All-cause mortality
timeFrame: Up to 180-days
measure: Cardiac death
timeFrame: Up to 180-days
measure: Unstable angina
timeFrame: Up to 180-days
measure: Acute myocardial infarction
timeFrame: Up to 180-days
measure: Revascularization
timeFrame: Up to 180-days
measure: Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.
timeFrame: 30-days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center and Minneapolis Medical Research Foundation
name: Fred S Apple, PhD
role: PRINCIPAL_INVESTIGATOR
References: