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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction
• Intervention / Treatment: Diagnostic test: Cardiac troponin testing

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Consecutive 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study population; 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.	Diagnostic test: Cardiac troponin testing; Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Any death	Up to 180-days
Cardiac death	Death due to cardiac reasons.	Up to 180-days
Unstable angina	Diagnosis of unstable angina per chart review up to 180-days	Up to 180-days
Acute myocardial infarction	Diagnosis of Acute myocardial infarction per chart review up to 180 days.	Up to 180-days
Revascularization	Coronary artery bypass graft surgery or percutaneous coronary intervention	Up to 180-days
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

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Collaborators: Abbott Diagnostics Division; Hennepin County Medical Center, Minneapolis
• Investigators: Principal Investigator: Fred S Apple, PhD, Hennepin County Medical Center and Minneapolis Medical Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: acute myocardial infarction; troponin; high-sensitivity cardiac troponin
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Myocardial Infarction; Infarction; Hypersensitivity; Acute Coronary Syndrome
• Other Study ID Numbers: CONTRAST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes