Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02490969
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2015-06-25
Brief Title:
Copeptin Registry proCORE Biomarkers in Cardiology BIC-19
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Copeptin Registry proCORE Biomarkers in Cardiology BIC-19
Status:
COMPLETED
Status Verified Date:
2017-05
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:
proCORE
Brief Summary:
Registry of an interventional Study-proved Strategy BIC-8 using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction AMI in Patients with Suspected Acute Coronary Syndrome ACS and a low-to intermediate risk profile
Detailed Description:
Registry of an interventional Study-proved Strategy BIC-8 using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction AMI in Patients with Suspected Acute Coronary Syndrome ACS and a low-to intermediate risk profile
Primary objective
To monitor the safety of the early rule-out strategy using combined testing of copeptin and troponin at admission of patients with signs and symptoms suggestive of ACS and a low- to intermediate risk profile who are discharged or moved to another hospital after testing copeptin and troponin negative defined as copeptin below 10 pmoll and cardiac troponin below 99th percentile URL
Secondary objectives
To monitor routine application of the early rule-out strategy patient characteristics risk profile of all patients tested for copeptin and troponin at admission irrespective of their biomarker test result
To monitor diagnoses clinical course and outcome of all patients tested for copeptin and troponin at admission
Primary objective
To monitor the safety of the early rule-out strategy using combined testing of copeptin and troponin at admission of patients with signs and symptoms suggestive of ACS and a low- to intermediate risk profile who are discharged or moved to another hospital after testing copeptin and troponin negative defined as copeptin below 10 pmoll and cardiac troponin below 99th percentile URL
Secondary objectives
To monitor routine application of the early rule-out strategy patient characteristics risk profile of all patients tested for copeptin and troponin at admission irrespective of their biomarker test result
To monitor diagnoses clinical course and outcome of all patients tested for copeptin and troponin at admission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None