Clinical trial NCT05853042: MERITnI - Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon.
Official title: MERITnI - Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myocardial Infarction
Acute Coronary Syndrome
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
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Mindray Bio-Medical Electronics Co., Ltd.
First posted: 2023-05-10
Enrollment: 1500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: Day 1
measure: Examine Concordance
timeFrame: Day 1
measure: Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction.
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: Impact on the incidence of myocardial injury and myocardial infarction diagnoses.
timeFrame: Day 1
Secondary outcomes:
measure: All-cause mortality
timeFrame: up to 30 days
measure: Cardiac mortality
timeFrame: up to 30 days
measure: Adjudicated index acute myocardial infarction according to Fourth Universal Definition of Myocardial Infarction.
timeFrame: on admission
measure: Safety Outcomes
timeFrame: 30 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute / Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Fred S Apple, PhD
role: PRINCIPAL_INVESTIGATOR
References: