Acute Coronary Syndrome Clinical Trial
— MERITnIOfficial title:
MERITnI - Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon.
Verified date | March 2024 |
Source | Hennepin Healthcare Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Active, not recruiting |
Enrollment | 1500 |
Est. completion date | May 15, 2024 |
Est. primary completion date | March 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Hennepin Healthcare Research Institute / Hennepin County Medical Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Hennepin Healthcare Research Institute | Mindray Bio-Medical Electronics Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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(Day 1 |
| |
Primary | 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 | |
Primary | 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:
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 |
Day 1 | |
Primary | 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. | Day 1 | |
Primary | 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 | |
Secondary | All-cause mortality | All cause death | up to 30 days | |
Secondary | Cardiac mortality | Death due to cardiac pathophysiology | up to 30 days | |
Secondary | 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 | |
Secondary | Safety Outcomes | Determine major adverse cardiovascular events, including cardiac death, myocardial infarction, unplanned revascularization and all-cause death. | 30 days |
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