Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05902117
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-05-11
Brief Title:
Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST ACS
Sponsor:
Hôpital NOVO
Organization:
Hôpital NOVO
Study Overview
Official Title:
Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST ACS in the Management of Pre-hospital and In-hospital Non-traumatic Chest Pain in Adults
Status:
RECRUITING
Status Verified Date:
2024-06
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:
CopSCA
Brief Summary:
The aim of this study is to demonstrate that a combined troponin and copeptin assay can exclude non-ST ACS in patients with chest pain less than 6 hours old
Detailed Description:
Chest pain accounts for about 10 of emergency service visits which represents between 6 and 8 million visits per year in the United States and 15 million in Europe Depending on the series coronary etiology is found in 10 to 50 of cases
Two types of coronary syndrome are distinguished according to the existence of a pathological change in the electrocardiogram
ST acute coronary syndrome is a diagnosis based on the association of chest pain associated with an electrocardiogram change in the form of ST-segment elevation in a systemic territory corresponding to the complete obstruction of an artery of the coronary network
Non-ST coronary syndrome is more difficult to diagnose as the ECG is not pathological or cannot be interpreted due to the presence of conduction disorders The diagnosis is currently based on the pathological increase of a specific myocardial biomarker in the blood troponin
If the pain is recent less than six hours the troponin measured on arrival may be falsely negative and therefore requires a second measurement 3 hours after the first one this is the troponin cycle This second test therefore leads to a longer stay for patients requiring it and contributes to the saturation of the emergency service
Copeptin is an endogenous stress biomarker that rises immediately during a myocardial infarction and decreases rapidly Unlike troponin this marker is not myocardial specific and its level can rise in the blood for many reasons which is why this marker cannot be used alone in the diagnosis of non-ST acute coronary syndrome non-ST ACS or ST- ACS
The hypothesis would be that the association of a copeptin assay with the initial troponin assay could if both markers are below pathological thresholds Troponin 16ngdL eliminate the diagnosis of acute coronary syndrome from the first assays and thus avoid the second troponin assay 3 hours after the first The patient would reduce the time spent in the emergency and would thus reduce the number of patients in the emergency service
Two types of coronary syndrome are distinguished according to the existence of a pathological change in the electrocardiogram
ST acute coronary syndrome is a diagnosis based on the association of chest pain associated with an electrocardiogram change in the form of ST-segment elevation in a systemic territory corresponding to the complete obstruction of an artery of the coronary network
Non-ST coronary syndrome is more difficult to diagnose as the ECG is not pathological or cannot be interpreted due to the presence of conduction disorders The diagnosis is currently based on the pathological increase of a specific myocardial biomarker in the blood troponin
If the pain is recent less than six hours the troponin measured on arrival may be falsely negative and therefore requires a second measurement 3 hours after the first one this is the troponin cycle This second test therefore leads to a longer stay for patients requiring it and contributes to the saturation of the emergency service
Copeptin is an endogenous stress biomarker that rises immediately during a myocardial infarction and decreases rapidly Unlike troponin this marker is not myocardial specific and its level can rise in the blood for many reasons which is why this marker cannot be used alone in the diagnosis of non-ST acute coronary syndrome non-ST ACS or ST- ACS
The hypothesis would be that the association of a copeptin assay with the initial troponin assay could if both markers are below pathological thresholds Troponin 16ngdL eliminate the diagnosis of acute coronary syndrome from the first assays and thus avoid the second troponin assay 3 hours after the first The patient would reduce the time spent in the emergency and would thus reduce the number of patients in the emergency service
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