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

Acute Coronary Syndrome Clinical Trial

— CONTRAST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03214029
• Other study ID #: CONTRAST
• Status: Active, not recruiting
• Start date: November 6, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Hypersensitivity
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• Cardiac troponin testing
Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	Abbott Diagnostics Division, Hennepin County Medical Center, Minneapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.	Diagnostic performance of cardiac troponin assays for the diagnosis of acute myocardial injury and myocardial infarction	on admission
Secondary	All-cause mortality	Any death	Up to 180-days
Secondary	Cardiac death	Death due to cardiac reasons.	Up to 180-days
Secondary	Unstable angina	Diagnosis of unstable angina per chart review up to 180-days	Up to 180-days
Secondary	Acute myocardial infarction	Diagnosis of Acute myocardial infarction per chart review up to 180 days.	Up to 180-days
Secondary	Revascularization	Coronary artery bypass graft surgery or percutaneous coronary intervention	Up to 180-days
Secondary	Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.	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.	30-days