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NCT Number: NCT05853042

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

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).

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Key information

Conditions

Acute Myocardial Infarction Acute Coronary Syndrome Cardiomyopathy, Dilated, 1FF Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hennepin Healthcare Research Institute / Hennepin County Medical Center

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

high-sensitivity cardiac troponin testing

Diagnostic Test

Lithium heparin plasma samples will be measured with Mindray Bio-Medical CL-1200i Chemiluminescence Immunoassay Analyzer.

Primary outcomes

  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.

    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.

  2. 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.

  3. 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:

    • Single measurement rule out strategy
    • Limit of detection (LoD)
    • 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
    • Accelerated serial sampling (0/2h protocol) rule out strategy

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

    • Diagnosis performance predicated on sex-specific 99th percentile URLs

  4. 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.

  5. 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.

Secondary outcomes

  1. All-cause mortality

    Time frame: up to 30 days

    All cause death

  2. Cardiac mortality

    Time frame: up to 30 days

    Death due to cardiac pathophysiology

  3. 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.

  4. Safety Outcomes

    Time frame: 30 days

    Determine major adverse cardiovascular events, including cardiac death, myocardial infarction, unplanned revascularization and all-cause death.

Sponsors and collaborators

Lead sponsor

Fred Apple

Other

Collaborators

  • Mindray Bio-Medical Electronics Co., Ltd.

Registry information

Acronym: MERITnI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 10, 2023
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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