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

NCT05853042 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2024-10-09

No results posted yet for this 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).

Conditions

  • Acute Myocardial Infarction
  • Acute Coronary Syndrome

Interventions

DIAGNOSTIC_TEST

high-sensitivity cardiac troponin testing

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

Sponsors & Collaborators

  • Mindray Bio-Medical Electronics Co., Ltd.

    collaborator UNKNOWN

  • Hennepin Healthcare Research Institute

    lead OTHER

Principal Investigators

  • Fred S Apple, PhD · Hennepin Healthcare Research Institute

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2025-03-15
Completion
2025-05-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05853042 on ClinicalTrials.gov