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NCT05853042 · ClinicalTrials.gov registry record
MERITnI - Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon.
A clinical trial of Acute Coronary Syndrome and Acute Myocardial Infarction, sponsored by Hennepin Healthcare Research Institute.
- Active
- Registry status
- 1,500
- Enrollment target
- 1
- Study location
NCT05853042: Active study of Acute Coronary Syndrome and Acute Myocardial Infarction, sponsored by Hennepin Healthcare Research Institute.
NCT05853042 is a study of Acute Coronary Syndrome and Acute Myocardial Infarction that is active but no longer recruiting, run by Hennepin Healthcare Research Institute. The registered enrollment target is 1,500 participants, below the 2,684-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05853042, a study of Acute Coronary Syndrome and Acute Myocardial Infarction, is active but no longer recruiting, sponsored by Hennepin Healthcare Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- 1,500 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST high-sensitivity cardiac troponin testing
Study Locations (1)
Minnesota
- Hennepin Healthcare Research Institute / Hennepin County Medical Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2022-12-12 |
| Est. Completion | 2025-05-15 |
What the registry record for NCT05853042 still lists
NCT05853042 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, below the 2,684-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (44% lower).
The record links to 2 conditions, with Acute Coronary Syndrome appearing as the primary indexed condition, and to 1 intervention - of which high-sensitivity cardiac troponin testing is the first listed.
NCT05853042 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05853042 about?
NCT05853042 is a clinical study titled "MERITnI - Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon.". 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...
What is the current status of trial NCT05853042?
This trial is currently active not recruiting. The enrollment target is 1,500 participants. The study started on 2022-12-12. Estimated completion is 2025-05-15.
What conditions does trial NCT05853042 study?
This clinical trial studies the following conditions: Acute Coronary Syndrome, Acute Myocardial Infarction.
What interventions are being tested in trial NCT05853042?
The interventions under investigation include: high-sensitivity cardiac troponin testing (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05853042?
This trial is sponsored by Hennepin Healthcare Research Institute, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05853042 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05853042's enrollment target sits among peer trials
1,500 13th of 40 higher than 28 of 40 other Acute Coronary Syndrome trials
participants (enrollment target), bucketed by value
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