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

Completed

Conditions studied: Acute Myocardial Infarction, Acute Coronary Syndrome

In brief

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).

Key facts

Study ID

NCT05853042

Run by

Fred Apple

People needed

1559

Starts

2022-12-12

Expected to finish

2025-07-07

Last updated by the study team

2026-07-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Hennepin Healthcare Research Institute / Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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