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| Name | Class |
|---|---|
| Mindray Bio-Medical Electronics Co., Ltd. | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-sensitivity cardiac troponin testing | Diagnostic Test | Lithium heparin plasma samples will be measured with Mindray Bio-Medical CL-1200i Chemiluminescence Immunoassay Analyzer. |
| 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. | 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 | 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. | 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:
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All cause death | up to 30 days |
| Cardiac mortality | Death due to cardiac pathophysiology | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Fred S Apple, PhD | Hennepin Healthcare Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare Research Institute / Hennepin County Medical Center | Minneapolis | Minnesota | 55404 | United States |
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Plasma samples tested on the Mindray Bio-Medical CL-1200i Chemiluminescence Immunoassay Analyzer.
| Day 1 |
| 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. | Day 1 |
| 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. | on admission |
| Safety Outcomes | Determine major adverse cardiovascular events, including cardiac death, myocardial infarction, unplanned revascularization and all-cause death. | 30 days |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| C567654 | Cardiomyopathy, Dilated, 1FF |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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