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Acute Myocardial InfarctionMERITnINCT05853042

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

An observational study of Acute Myocardial Infarction and Acute Coronary Syndrome, run by Fred Apple at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
high-sensitivity cardiac troponin testing
How many people
1,559 participants
Where
1 siteUnited States
Study dates
12 Dec 2022to 7 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hennepin Healthcare Research Institute / Hennepin County Medical Center

    Minneapolis, Minnesota, 55404

Other trials in United States

About this study

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).

Read the 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.
Being tested
high-sensitivity cardiac troponin testing
Keywords
cardiac troponin, acute myocardial injury, acute myocardial infarction, high-sensitivity cardiac troponin I, Mindray, Mindray Bio-medical, Cardiac troponin I, Reference range, Abbott Alinity, Type 1 myocardial infarction, Type 2 myocardial infarction, Risk outcomes assessment
Medical subject headings
Acute Coronary Syndrome, Cardiomyopathy, Dilated, 1FF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-sensitivity cardiac troponin testingDiagnostic test

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

Study groups in NCT05853042
Study groupRoleWhat they receive
CohortStudy 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.
Receives: Diagnostic Test: high-sensitivity cardiac troponin testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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.

    Measured: Day 1

  2. Examine Concordance

    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.

    Measured: Day 1

  3. Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction.

    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
    2. Limit of detection (LoD)
    3. 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
    4. Accelerated serial sampling (0/2h protocol) rule out strategy
    5. Delta (absolute concentration serial change value, 0-2h) analysis
    6. Diagnosis performance predicated on sex-specific 99th percentile URLs

    Measured: Day 1

  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

    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.

    Measured: Day 1

  5. Impact on the incidence of myocardial injury and myocardial infarction diagnoses.

    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.

    Measured: Day 1

Secondary outcomes (4)

  1. All-cause mortality

    All cause death

    Measured: up to 30 days

  2. Cardiac mortality

    Death due to cardiac pathophysiology

    Measured: up to 30 days

  3. Adjudicated index acute myocardial infarction according to Fourth Universal Definition of Myocardial Infarction.

    Acute myocardial infarction including all sub-types following the Fourth Universal Definition of Myocardial Infarction guidelines.

    Measured: on admission

  4. Safety Outcomes

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start12 Dec 2022
  3. Primary completion7 Jul 2025
  4. Study completion7 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05853042
Sponsor's protocol ID
MERITnI
Acronym
MERITnI
Status last verified
Jul 2026
First submitted
1 May 2023
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Apple FS, Buda KG, Wagner BP, Sandoval Y, Smith SW, Brown HM, Miller JR, Sexter A, Schulz K, Jaffe AS. Distinguishing Acute Myocardial Infarction from Other Forms of Cardiac Injury with the Cardiac Troponin Long-T ITC Complex and High-Sensitivity Troponin I and T in Patients with Suspected Acute Coronary Syndrome: MERITnI Substudy. Clin Chem. 2026 Aug 20:hvag098. doi: 10.1093/clinchem/hvag098. Online ahead of print.

    PubMed 42621672

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction and Acute Coronary Syndrome, run by Fred Apple at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05853042, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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