Status:
COMPLETED
Safe Emergency Department DIscharGE Rate (SEIGE)
Lead Sponsor:
Hennepin Healthcare Research Institute
Collaborating Sponsors:
Siemens Healthineers
Conditions:
Acute Myocardial Infarction
Acute Coronary Syndrome
Eligibility:
All Genders
21+ years
Brief 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...
Detailed Description
Study purpose/objective: * Evaluate the clinical performance of the Siemens POC HS cTn-I test system for the diagnosis and rule out of AMI in patients presenting to the emergency department in whom s...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS event.
- Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement.
- At least one 12-lead electrocardiogram
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
October 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 13 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04772157
Start Date
October 13 2020
End Date
October 13 2024
Last Update
December 17 2024
Active Locations (1)
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1
Hennepin Healthcare Research Institute / Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55404