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

N/AActive Not RecruitingNCT05853042

Hennepin Healthcare Research Institute1,500 enrolled

Overview

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 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

1,500

Conditions

Acute Myocardial Infarction Acute Coronary Syndrome

Interventions

high-sensitivity cardiac troponin testingDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Hennepin Healthcare Research Institute / Hennepin County Medical Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 1

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.

Time frame: Day 1

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 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

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

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.

Data from ClinicalTrials.gov

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Secondary Outcomes

All-cause mortality

All cause death

Time frame: up to 30 days

Cardiac mortality

Death due to cardiac pathophysiology

Time frame: up to 30 days

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.

Time frame: on admission

Safety Outcomes

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

Time frame: 30 days