Ignite Creation Date:
2024-05-06 @ 2:05 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01962506
Status:
UNKNOWN
Last Update Posted:
2013-10-14
First Post:
2013-10-10
Brief Title:
Diagnostic Utility of Copeptin in Addition to High-sensitivity Cardiac Troponin for the Early Diagnosis of NSTE-ACS
Sponsor:
G dAnnunzio University
Organization:
G dAnnunzio University
Study Overview
Official Title:
Diagnostic Utility of Copeptin in Addition to High-sensitivity Cardiac Troponin for the Early Diagnosis of Non-ST-Elevation Acute Coronary Syndromes - The COPACS Study
Status:
UNKNOWN
Status Verified Date:
2013-10
Last Known Status:
RECRUITING
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:
COPACS
Brief Summary:
Rapid and reliable exclusion of acute myocardial infarction AMI during an emergency department ED triage is a major unmet clinical need We aimed at verifying the non-inferiority of a single-sampling strategy of hs-cTn and copeptin compared with the dual hs-cTn sampling for the early diagnosis of Non-ST-Elevation Acute Coronary Syndromes NSTE-ACS versus Non Coronary Chest Pain NCCP in a selected cohort of consecutive patients admitted at the Emergency Department
Detailed Description:
The evaluation of chest pain patients in the emergency department remains a costly and difficult challenge because a large proportion of them do not suffer from an acute coronary syndrome ACS The adequate ruling out of ACS in patients with chest pain is crucial as the erroneous discharge of a patient with ACS is associated with a high risk of cardiac events Rapid assessment of these patients is critical to direct further diagnostic and therapeutic strategies Electrocardiography ECG and cardiac troponin cTn are the current diagnostic cornerstones and complement clinical assessment in current AMI guidelines1 They allow to rule in an acute myocardial infarction AMI within the first 3 hours after presentation in the majority of patients and offer the opportunity to initiate appropriate evidence-based treatment The vast majority of patients presenting to the Emergency Department ED with suspected AMI however finally prove not to have AMI The current process of ruling out AMI is time-consuming and expensive One fourth to one-third of patients with AMI present without significant ECG changes indicative of acute ischemia therefore the ECG is of little help to rule out AMI especially in the setting of non-ST elevation ACS NSTE-ACS High-sensitivity hs-cTn assays have been developed recently enabling measurements of concentrations that are 10-fold lower than those previously measurable Recent studies have confirmed the increased accuracy of these high-sensitivity assays compared with conventional assays in the early detection of AMI and in the safely ruling in or out of coronary causes of chest pain However concerns have been raised about a possible specificity deficit with these new assays In addition a second measurement of hs-cTn may be warranted in order to increase the accuracy of the assay
Copeptin the C-terminal part of the vasopressin pro-hormone and a marker of acute endogenous stress has been demonstrated to be useful for a more rapid ruling out of acute myocardial infarction Current evidence for the diagnostic validity and performance of a combination of high sensitivity-cardiac troponin and copeptin is limited and controversial A Bayesian probabilistic approach is likely to be the correct way to evaluate the possible incremental value of copeptin in the detection of ACS Thus we aim at prospectively evaluating the diagnostic accuracy of copeptin hs-cTn CK-MB and myoglobin alone or in combination with hs-cTn for the early diagnosis and ruling out of Non-ST-Elevation NSTE ACS versus non-cardiac causes of chest pain in a selected cohort of Emergency Department ED chest pain patients according to their pre-test probability as assessed through a combination of two validated clinical risk score systems ie Chest Pain Score and TIMI Risk Score
Copeptin the C-terminal part of the vasopressin pro-hormone and a marker of acute endogenous stress has been demonstrated to be useful for a more rapid ruling out of acute myocardial infarction Current evidence for the diagnostic validity and performance of a combination of high sensitivity-cardiac troponin and copeptin is limited and controversial A Bayesian probabilistic approach is likely to be the correct way to evaluate the possible incremental value of copeptin in the detection of ACS Thus we aim at prospectively evaluating the diagnostic accuracy of copeptin hs-cTn CK-MB and myoglobin alone or in combination with hs-cTn for the early diagnosis and ruling out of Non-ST-Elevation NSTE ACS versus non-cardiac causes of chest pain in a selected cohort of Emergency Department ED chest pain patients according to their pre-test probability as assessed through a combination of two validated clinical risk score systems ie Chest Pain Score and TIMI Risk Score
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