Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01498731
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2011-10-25
Brief Title:
Effect of the Biomarker Copeptin in Managing Patients With Suspected Acute Coronary Syndrome ACS
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
The Effect of Integrating the Biomarker Copeptin Into the Process of Managing Patients With Suspected ACS
Status:
COMPLETED
Status Verified Date:
2013-06
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:
BiC-8
Brief Summary:
Acute chest pain is commonly known to be the classic symptom of acute myocardial infarction Of the many patients which visit the Emergency Department because of chest pain less than half do actually suffer from an acute myocardial infarction or acute myocardial ischemia In some patients the acute myocardial infarction can be diagnosed at admission either because of typical changes in their ECG STEMI ST-elevation myocardial infarctionor because of increased levels of the laboratory value Troponin in their blood NSTEMI Non-ST-elevation myocardial infarction Troponin is currently the most important marker to diagnose acute myocardial infarction Unfortunately a lot of patients with suspected acute coronary syndrome do not show any ECG or Troponin changes These patients pose a major problem in emergency medicine as they need to precautionally be admitted to a chest pain unit and to be started on medical treatment until a second Troponin test after 6-9 hours is available
In this study we investigate the biomarker Copeptin Copeptin has shown excellent results in diagnostic clinical trials assessing its use in various acute diseases There are three important trials showing an excellent negative predictive value of Copeptin in combination with Troponin in patients with suspected acute coronary syndrome Reichlin et al JACC 2009 Keller et al JACC 2010 Giannitsis et al Clin Chem 2011
This trial compares two processes of managing patients with suspected acute coronary syndrome ACS the standard process according to current guidelines and the experimental process integrating copeptin as a rule-out marker for acute myocardial infarction into management decisions Main Hypothesis Patients with suspected ACS who test negative for Troponin and negative for Copeptin at their initial presentation to the ED can safely be discharged interventional process They will not experience more major cardiac adverse events than patients who were managed by standard practise control processwithin 30 days after admission
The Investigators want to test Copeptin in patients with suspected acute coronary syndrome in whom the ECG is unspecific and the initial Troponin test is negative Further patient care will be based on the Copeptin result Patients with a negative Copeptin will be discharged into the ambulant care of resident cardiologistsCopeptin positive patients will be managed according to standard guidelines for the management of patients with ACS
In this study we investigate the biomarker Copeptin Copeptin has shown excellent results in diagnostic clinical trials assessing its use in various acute diseases There are three important trials showing an excellent negative predictive value of Copeptin in combination with Troponin in patients with suspected acute coronary syndrome Reichlin et al JACC 2009 Keller et al JACC 2010 Giannitsis et al Clin Chem 2011
This trial compares two processes of managing patients with suspected acute coronary syndrome ACS the standard process according to current guidelines and the experimental process integrating copeptin as a rule-out marker for acute myocardial infarction into management decisions Main Hypothesis Patients with suspected ACS who test negative for Troponin and negative for Copeptin at their initial presentation to the ED can safely be discharged interventional process They will not experience more major cardiac adverse events than patients who were managed by standard practise control processwithin 30 days after admission
The Investigators want to test Copeptin in patients with suspected acute coronary syndrome in whom the ECG is unspecific and the initial Troponin test is negative Further patient care will be based on the Copeptin result Patients with a negative Copeptin will be discharged into the ambulant care of resident cardiologistsCopeptin positive patients will be managed according to standard guidelines for the management of patients with ACS
Detailed Description:
The management of patients with suspected Non-ST elevation acute coronary syndrome NSTEACS can be time-consuming and expensive Often patients need to be hospitalized for precautionary medical treatment and serial Troponin testing until further decisions can be made
Copeptin a 39 amino acid glycopeptide is the C-terminal portion of Pro-Vasopressin It is co-secreted from the posterior pituitary gland together with Vasopressin and mirrors the amount of Vasopressin in the circulation Vasopressin is primarily known as Anti-Diuretic Hormone ADH which acts in the kidney to regulate the bodys retention of water and in high concentration causes arterial vasoconstriction
Vasopressin is as a central hormone also a crucial part of the hypothalamo-pituitary-adrenal axis which responds to severe life-threatening stress inputs its levels reflect the bodys individual stress levelVasopressin itself has a half-life of 5-10 minutes and is therefore difficult to measure in-vivo Copeptin is secreted stoichiometrically with Vasopressin it remains stable for days after blood withdrawal and can therefore easily be measured Copeptin has been studied as a diagnostic and prognostic marker since 2006 In acute myocardial infarction Copeptin levels have been shown to increase early after the onset of symptoms 0-4 hours and start decreasing after 4-5 hours
In acute myocardial infarction AMI Copeptin levels increase early after the onset of symptoms In patients with suspected ACS Copeptin levels were significantly higher in patients with AMI than in patients with other diagnoses Copeptin in conjunction with Troponin T was particularly useful as a rule-out marker of AMI
This is a randomized controlled diagnostic trial to quantify the benefit of integrating Copeptin into the management process of patients with NSTEACS and a negative baseline Troponin I test result in the Chest Pain Unit CPU Patient management will depend on Copeptin rather than serial Troponin results Patients will be randomized in either a standard group management according to current guidelines on managing patients with ACS Copeptin will be tested but result will not be revealed to treating personnel or an interventional group Copeptin testing further management dependent on Copeptin result
In this interventional group patients with a negative baseline Copeptin will be discharged into the ambulant care of co-operating resident cardiologists Patients with a positive Copeptin result will be treated as by standard care like patients in the control group
The investigators will assess the efficacy and safety of the new process as compared to the standard process Secondary endpoints will assess patient satisfaction and length of hospital stay This study design will not only assess the diagnostic use but also the clinical relevance of Copeptin testing in the EDCPU
Consecutive N-STEACS patients of the Chest Pain Unit with a negative Troponin I at admission will be invited to participate Troponin I is tested as part of the standard management of patients with suspected acute coronary syndrome on a point of care test device POCT
Patients who give their written informed consent will then be randomized into one of two study arms experimental and standard management where further management depends on their Copeptin result at admission
Copeptin a 39 amino acid glycopeptide is the C-terminal portion of Pro-Vasopressin It is co-secreted from the posterior pituitary gland together with Vasopressin and mirrors the amount of Vasopressin in the circulation Vasopressin is primarily known as Anti-Diuretic Hormone ADH which acts in the kidney to regulate the bodys retention of water and in high concentration causes arterial vasoconstriction
Vasopressin is as a central hormone also a crucial part of the hypothalamo-pituitary-adrenal axis which responds to severe life-threatening stress inputs its levels reflect the bodys individual stress levelVasopressin itself has a half-life of 5-10 minutes and is therefore difficult to measure in-vivo Copeptin is secreted stoichiometrically with Vasopressin it remains stable for days after blood withdrawal and can therefore easily be measured Copeptin has been studied as a diagnostic and prognostic marker since 2006 In acute myocardial infarction Copeptin levels have been shown to increase early after the onset of symptoms 0-4 hours and start decreasing after 4-5 hours
In acute myocardial infarction AMI Copeptin levels increase early after the onset of symptoms In patients with suspected ACS Copeptin levels were significantly higher in patients with AMI than in patients with other diagnoses Copeptin in conjunction with Troponin T was particularly useful as a rule-out marker of AMI
This is a randomized controlled diagnostic trial to quantify the benefit of integrating Copeptin into the management process of patients with NSTEACS and a negative baseline Troponin I test result in the Chest Pain Unit CPU Patient management will depend on Copeptin rather than serial Troponin results Patients will be randomized in either a standard group management according to current guidelines on managing patients with ACS Copeptin will be tested but result will not be revealed to treating personnel or an interventional group Copeptin testing further management dependent on Copeptin result
In this interventional group patients with a negative baseline Copeptin will be discharged into the ambulant care of co-operating resident cardiologists Patients with a positive Copeptin result will be treated as by standard care like patients in the control group
The investigators will assess the efficacy and safety of the new process as compared to the standard process Secondary endpoints will assess patient satisfaction and length of hospital stay This study design will not only assess the diagnostic use but also the clinical relevance of Copeptin testing in the EDCPU
Consecutive N-STEACS patients of the Chest Pain Unit with a negative Troponin I at admission will be invited to participate Troponin I is tested as part of the standard management of patients with suspected acute coronary syndrome on a point of care test device POCT
Patients who give their written informed consent will then be randomized into one of two study arms experimental and standard management where further management depends on their Copeptin result 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1118-1665 | REGISTRY | International Clinical Trials Registry Platform | None |
| DRKS00000276 | OTHER | None | None |