Status:
COMPLETED
Li-Hep vs. Non-Li-Hep Coated Transfer Device
Lead Sponsor:
VieCuri Medical Centre
Collaborating Sponsors:
Siemens Corporation, Corporate Technology
Conditions:
Acute Coronary Syndrome
Chest Pain
Eligibility:
All Genders
18+ years
Brief Summary
This study is a prospective, diagnostic, cohort study within the standard care of acute coronary syndrome (ACS) patients. It compares the analytical performance of Siemens® point-of-care high sensitiv...
Detailed Description
In September 2019, the validation study 1.0 started, in which the cTnI result of the Siemens POC device on three sample types are compared. Interim analysis of the sample comparison was performed by r...
Eligibility Criteria
Inclusion
- Age 18 years or older.
- Referred to cardiac ED with chest pain suspected of ACS; inclusion at arrival (T=0) or one hour after arrival (T=1).
- Subacute STEMI or NSTEMI patients admitted at the CCU who have an indication for coronary angiography but do not need rescue/emergency PCI.
- STEMI patients who already underwent rescue/emergency PCI; inclusion post PCI.
Exclusion
- Out of hospital cardiac arrest.
- Patients with sudden onset tachycardia and a frequency of 110 bpm or higher (supraventricular or ventricular).
- Patients who are hemodynamically unstable or in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
- Patients recently already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site.
- Patients not willing or not able to provide informed consent due to their medical condition as judged by the physician.
Key Trial Info
Start Date :
June 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04458155
Start Date
June 18 2020
End Date
April 1 2021
Last Update
June 10 2022
Active Locations (1)
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1
Viecuri Medical Center
Venlo, Limburg, Netherlands, 5912 BL