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

Acute Coronary Syndrome Clinical Trial

— MERITnI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05853042
• Other study ID #: MERITnI
• Status: Active, not recruiting
• Start date: December 12, 2022
• Est. completion date: May 15, 2024

Study information

• Verified date: March 2024
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• high-sensitivity cardiac troponin testing
Lithium heparin plasma samples will be measured with Mindray Bio-Medical CL-1200i Chemiluminescence Immunoassay Analyzer.

Locations

Country	Name	City	State
United States	Hennepin Healthcare Research Institute / Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	Mindray Bio-Medical Electronics Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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