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

NCT05853042 | Active Not Recruiting DMC

• 1 other identifier: MERITnI
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (5)

• 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: 1. Single measurement rule out strategy 1. Limit of detection (LoD) 2. 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 2. Accelerated serial sampling (0/2h protocol) rule out strategy a) Delta (absolute concentration serial change value, 0-2h) analysis 3. Diagnosis performance predicated on 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

  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

• 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 Outcomes (4)

• All-cause mortality

  up to 30 days

• Cardiac mortality

  up to 30 days

• Adjudicated index acute myocardial infarction according to Fourth Universal Definition of Myocardial Infarction.

  on admission

• Safety Outcomes

  30 days

Study Arms (1)

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

Interventions

high-sensitivity cardiac troponin testing DIAGNOSTIC_TEST

Lithium heparin plasma samples will be measured with Mindray Bio-Medical CL-1200i Chemiluminescence Immunoassay Analyzer.

Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS/ischemic event.
• Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement.
• At least one 12-lead electrocardiogram

You may not qualify if:

• Less than 21 years old
• Pregnancy
• Trauma
• Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes
• Did not present through the ED
• Transferred from an outside hospital or clinic
• Has already been enrolled in the study

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• Mindray Bio-Medical Electronics Co., Ltd.: collaborator

Study Sites (1)

Hennepin Healthcare Research Institute / Hennepin County Medical Center

Minneapolis, Minnesota, 55404, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples tested on the Mindray Bio-Medical CL-1200i Chemiluminescence Immunoassay Analyzer.

MeSH Terms

Conditions

Acute Coronary Syndrome; Cardiomyopathy, Dilated, 1FF

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Fred S Apple, PhD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 10, 2023
• Study Start: December 12, 2022
• Primary Completion: March 15, 2025
• Study Completion: May 15, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

US (1)