NCT05853042Completed

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

Source: ClinicalTrials.gov · Last updated 28 Jul 2026

Brief summary (registry, in English)

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 (registry): Completed
Study type: Observational
Enrollment: 1559 (actual)
First submitted: 1 May 2023
Start date: 12 Dec 2022
Primary completion date: 7 Jul 2025
Lead sponsor: Fred Apple
Diseases: Coronary artery disease
NCT number: NCT05853042

What you commit to

Study type: Observational
Participants enrolled: 1559
From 12 Dec 2022 to the primary completion date, 7 Jul 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

Less than 21 years old

Other

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

Who the study is looking for

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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Hennepin Healthcare Research Institute / Hennepin County Medical Center Coordinator of this site? Confirm its status	Minneapolis	United States	Unknown status

Related publications

Distinguishing Acute Myocardial Infarction from Other Forms of Cardiac Injury with the Cardiac Troponin Long-T ITC Complex and High-Sensitivity Troponin I and T in Patients with Suspected Acute Coronary Syndrome: MERITnI Substudy.Clin Chem · 2026 · PMID 42621672

This page is information, not medical advice. Discuss any trial with your doctor.