MERITnI - Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon.
Study Details
Study Description
Brief 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.
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Study purpose/objective:
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Determine the sex-specific 99th percentile upper reference limits (URLs) for the Mindray hs-cTnI assay using the CL-1200i Instrument.
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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.
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- 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. [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.
- Examine Concordance [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.
- Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction. [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
- 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 [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.
- Impact on the incidence of myocardial injury and myocardial infarction diagnoses. [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 Outcome Measures
- All-cause mortality [up to 30 days]
All cause death
- Cardiac mortality [up to 30 days]
Death due to cardiac pathophysiology
- Adjudicated index acute myocardial infarction according to Fourth Universal Definition of Myocardial Infarction. [on admission]
Acute myocardial infarction including all sub-types following the Fourth Universal Definition of Myocardial Infarction guidelines.
- Safety Outcomes [30 days]
Determine major adverse cardiovascular events, including cardiac death, myocardial infarction, unplanned revascularization and all-cause death.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS/ischemic event.
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Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement.
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At least one 12-lead electrocardiogram
Exclusion Criteria:
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Less than 21 years old
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Pregnancy
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Trauma
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Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes
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Did not present through the ED
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Transferred from an outside hospital or clinic
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Has already been enrolled in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hennepin Healthcare Research Institute / Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55404 |
Sponsors and Collaborators
- Hennepin Healthcare Research Institute
- Mindray Bio-Medical Electronics Co., Ltd.
Investigators
- Principal Investigator: Fred S Apple, PhD, Hennepin Healthcare Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MERITnI