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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03214029

Acronym

CONTRAST

Enrollment

2000

Registered

2017-07-11

Start date

2017-11-06

Completion date

2025-12-31

Last updated

2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Acute Myocardial Infarction

Keywords

troponin, high-sensitivity cardiac troponin, 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

Interventions

DIAGNOSTIC_TESTCardiac troponin testing

Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.	on admission	Diagnostic performance of cardiac troponin assays for the diagnosis of acute myocardial injury and myocardial infarction

Secondary

Measure	Time frame	Description
Cardiac death	Up to 180-days	Death due to cardiac reasons.
Unstable angina	Up to 180-days	Diagnosis of unstable angina per chart review up to 180-days
All-cause mortality	Up to 180-days	Any death
Revascularization	Up to 180-days	Coronary artery bypass graft surgery or percutaneous coronary intervention
Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.	30-days	Safety outcome for tested diagnostic strategies will be defined at 30-days, including index hospitalization events for MACE - Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.
Acute myocardial infarction	Up to 180-days	Diagnosis of Acute myocardial infarction per chart review up to 180 days.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026