Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05484544
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2022-07-31
Brief Title:
Safety and Efficacy of Hs-cTnT Protocols
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
Safety and Efficacy of Hs-cTnT Protocols
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chest pain is a common presenting complaint among patients in the emergency department ED A large portion of patients with chest pain undergo lengthy assessment in the ED or are admitted to rule out acute oronary syndrome ACS often with stress testing creating a substantial health care burden The new high-sensitivity cardiac troponin assays allow use of shorter time intervals for repeated blood samples and may improve care for chest pain patients The aim of this cohort is to evaluate high-sentivity troponin based protocols for ruling out and ruling in ACS in the ED
Detailed Description:
This is a prospective observational study conducted at Skåne University Hospital Lund Sweden Patients presenting with non-traumatic chest pain and for whom hs-cTnT testing was ordered at presentation will be enrolled between february 2013 to April 2014 after providing written informed consent Patients with STEMI during index visit and those with severe communication barriers will not be enrolled Enrolled patients will have a second blood sample for hs-cTnT analyzed 1 h after the first sample Patients with hemolysis with a hemoglobin concentration 01 gdl H-index 100 in either the 0- or
1-h sample will be excluded Clinical data and 1-h high sensitivity troponin T samples will be collected by research assistants Further diagnostic testing and treatment will be performed as in routine care at the discretion of the responsible physician
1-h sample will be excluded Clinical data and 1-h high sensitivity troponin T samples will be collected by research assistants Further diagnostic testing and treatment will be performed as in routine care at the discretion of the responsible physician
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None