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Safe Emergency Department DIscharGE Rate (SEIGE)

NCT04772157 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-12-17

No results posted yet for this study

Summary

The Siemens POC High Sensitivity Troponin-I Test System is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTn-I) in fresh human capillary (fingerstick) whole blood, and lithium-heparinized venous whole blood or plasma, to be used by healthcare professionals at the point of care (POC) as well as in the clinical laboratory.

The Siemens POC High Sensitivity Troponin-I Test System is to be used as an aid in the diagnosis of myocardial infarction (MI).

Conditions

  • Acute Myocardial Infarction
  • Acute Coronary Syndrome

Interventions

DIAGNOSTIC_TEST

Cardiac Troponin Testing

Lithium heparin whole blood and plasma samples will be measured with Siemens POC High Sensitivity Troponin-I Test System.

Sponsors & Collaborators

Principal Investigators

  • Fred S Apple, PhD · Hennepin Healthcare Research Institute

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-13
Primary Completion
2021-10-13
Completion
2024-10-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04772157 on ClinicalTrials.gov