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

NCT03214029 | Active Not Recruiting FDA Device

• 1 other identifier: CONTRAST
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction; Acute Coronary Syndrome

Keywords

troponin; high-sensitivity cardiac troponin; acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• All-cause mortality

  Up to 180-days

• Cardiac death

  Up to 180-days

• Unstable angina

  Up to 180-days

• Acute myocardial infarction

  Up to 180-days

• Revascularization

  Up to 180-days

Study Arms (1)

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

Interventions

Cardiac troponin testing DIAGNOSTIC_TEST

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

Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult, defined as subject 18 years of age or older
• Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial cTnI measurement.
• At least one 12-lead electrocardiogram

You may not qualify if:

• Currently pregnant
• Trauma related admission
• Cardiac arrest
• Decline to participate
• Did not present through the ED
• Transferred from an outside hospital

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• Abbott Diagnostics Division: collaborator
• Hennepin County Medical Center, Minneapolis: collaborator

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Excess blood is biobanked as EDTA-plasma and heparin samples after being used for the clinical cTnI assay

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Fred S Apple, PhD

  Hennepin County Medical Center and Minneapolis Medical Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 11, 2017
• Study Start: November 6, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

US (1)