COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial (CONTRAST)

Hennepin Healthcare

Status: Active, not recruiting

Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction

Treatments: Diagnostic Test: Cardiac troponin testing

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03214029

CONTRAST

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

Study population

Description:

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.

Treatment:

Diagnostic Test: Cardiac troponin testing