NCT04772157Completed
Safe Emergency Department DIscharGE Rate (SEIGE)
Evaluation of the Siemens POC HS CTn-I Test System
Source: ClinicalTrials.gov · Last updated 17 Dec 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1000 (actual)
- First submitted
- 23 Feb 2021
- Start date
- 13 Oct 2020
- Primary completion date
- 13 Oct 2021
- Lead sponsor
- Hennepin Healthcare Research Institute
- Diseases
- Coronary artery disease
- NCT number
- NCT04772157
What you commit to
- Study type: Observational
- Participants enrolled: 1000
- From 13 Oct 2020 to the primary completion date, 13 Oct 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Less than 21 years old
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hennepin Healthcare Research Institute / Hennepin County Medical Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.