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NCT03214029 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design

Related Conditions & MeSH terms

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
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