MERITnI - Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon. (MERITnI)

March 12, 2024 updated by: Hennepin Healthcare Research Institute

The Mindray High Sensitivity Troponin-I Measurement System is an in vitro diagnostic test for the quantitative determination of high sensitivity cardiac troponin I (hs-cTnI) in human serum or plasma.

The Mindray High Sensitivity Troponin-I Measurement System is to be used as an aid in the diagnosis and rule out of acute myocardial infarction (AMI).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study purpose/objective:

  • Determine the sex-specific 99th percentile upper reference limits (URLs) for the Mindray hs-cTnI assay using the CL-1200i Instrument.
  • Method comparison across the dynamic range of cTnI concentrations between the Mindray hs-cTnI assay and the Abbott Alinity hs-TnI assay used in clinical practice at Hennepin Healthcare/Hennepin County Medical Center.
  • Evaluate the clinical performance of the Mindray hs- cTnI measuring system for the diagnosis of myocardial infarction (MI), for early rule out MI and myocardial injury, and assessment of 30-day safety outcomes in patients presenting to the emergency department (ED) in whom serial cTnI measurements (0h, 2h, 4h, 6h) are obtained on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN USA) to rule-in and rule-out MI.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Hennepin Healthcare Research Institute / Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients (goal, 1500 patients over 4 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.

Description

Inclusion Criteria:

  1. Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS/ischemic event.
  2. Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement.
  3. At least one 12-lead electrocardiogram

Exclusion Criteria:

  1. Less than 21 years old
  2. Pregnancy
  3. Trauma
  4. Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes
  5. Did not present through the ED
  6. Transferred from an outside hospital or clinic
  7. Has already been enrolled in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Study population: Prospective, observational cohort study of consecutive patients (goal, 1500 patients over 4 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.
Diagnostic test: high-sensitivity cardiac troponin testing
Lithium heparin plasma samples will be measured with Mindray Bio-Medical CL-1200i Chemiluminescence Immunoassay Analyzer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine the incidence of undetectable(<LoD), measurable (LoD - 99th percentile), and increased (>99th percentile) cTn concentrations for the Mindray Bio-Medical hs-cTnI assay using the CL-1200i analyzer.
Time Frame: Day 1
Examine the incidence of undetectable(<LoD), measurable (LoD - 99th percentile), and increased (>99th percentile) cTn concentrations for the Mindray Bio-Medical hs-cTnI assay using the CL-1200i analyzer in comparison to a high sensitivity cTnI assay (Abbott Alinity) to determine the potential impact on positivity rate, defined by sex-specific 99th percentiles.
Day 1
Examine Concordance
Time Frame: Day 1
Examine analytical and clinical concordance and discordance predicated on sex-specific 99th percentiles between Mindray hs-cTnI concentrations in comparison to the Abbott Alinity high sensitivity cTnI assay.
Day 1
Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction.
Time Frame: Day 1

Examine the diagnostic performance for a) acute myocardial injury and b) acute myocardial infarction based on various diagnostic strategies using hs-cTnI measurement(s), as follows:

  1. Single measurement rule out strategy

    1. Limit of detection (LoD)
    2. Derive an optimal rule-out (ng/L) hs-cTnI cutoff for the Mindray Bio-Medical hs-cTnI assay using the CL-1200i analyzer to meet an early rule out clinical need

  2. Accelerated serial sampling (0/2h protocol) rule out strategy

    a) Delta (absolute concentration serial change value, 0-2h) analysis

  3. Diagnosis performance predicated on sex-specific 99th percentile URLs
Day 1
Describe the incidence of MI and myocardial injury, clinical characteristics and 30-day safety outcomes risk of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs
Time Frame: Day 1
Describe the incidence of MI and myocardial injury, clinical characteristics and 30-day safety outcomes risk of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs, including patients categorized with acute myocardial injury and acute myocardial infarction, including type 1 and 2 myocardial infarction, following the 4th Universal Definition of Myocardial Infarction.
Day 1
Impact on the incidence of myocardial injury and myocardial infarction diagnoses.
Time Frame: Day 1
Examine the potential impact on the incidence of myocardial injury and myocardial infarction diagnoses using hs-cTnI upon clinical practice implementation with a comparison to the hospital's final ICD-10 code diagnosis of type 1 and type 2 MIs, and non-MI myocardial injury.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: up to 30 days
All cause death
up to 30 days
Cardiac mortality
Time Frame: up to 30 days
Death due to cardiac pathophysiology
up to 30 days
Adjudicated index acute myocardial infarction according to Fourth Universal Definition of Myocardial Infarction.
Time Frame: on admission
Acute myocardial infarction including all sub-types following the Fourth Universal Definition of Myocardial Infarction guidelines.
on admission
Safety Outcomes
Time Frame: 30 days
Determine major adverse cardiovascular events, including cardiac death, myocardial infarction, unplanned revascularization and all-cause death.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Collaborators

Mindray Bio-Medical Electronics Co., Ltd.

Investigators

  • Principal Investigator: Fred S Apple, PhD, Hennepin Healthcare Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 1, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MERITnI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on high-sensitivity cardiac troponin testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe