CompletedNot Applicable

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

United States1,559 participantsStarted 2022-12-12

Plain-language 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).

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Less than 21 years old
. Pregnancy
. Trauma
. Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Examine Concordance

Timeframe: Day 1

Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction.

Timeframe: 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

Timeframe: Day 1

Impact on the incidence of myocardial injury and myocardial infarction diagnoses.

Timeframe: Day 1

Trial details

NCT IDNCT05853042

SponsorFred Apple

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-07

View on ClinicalTrials.gov More Acute Myocardial Infarction trials

Plain-language summary

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Less than 21 years old
. Pregnancy
. Trauma
. Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes

What they're measuring

Timeframe: Day 1

Examine Concordance

Timeframe: Day 1

Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction.

Timeframe: 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

Timeframe: Day 1

Impact on the incidence of myocardial injury and myocardial infarction diagnoses.

Timeframe: Day 1