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

Active, not recruiting

• Conditions: Acute Myocardial Infarction; Acute Coronary Syndrome
• Interventions: Diagnostic Test: Cardiac troponin testing

• Registration Number: NCT03214029
• Lead Sponsor: Hennepin Healthcare Research Institute

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

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Study Start: 2017-11-06
• Primary Completion: 2022-12-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Cardiac troponin testing	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All-cause mortality	Up to 180-days	Any death
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
Acute myocardial infarction	Up to 180-days	Diagnosis of Acute myocardial infarction per chart review up to 180 days.
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.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States