Trial document




drksid header

  DRKS00000276

Trial Description

start of 1:1-Block title

Title

Biomarkers in Cardiology (BIC) -8: The effect of integrating the biomarker Copeptin into the process of managing patients with suspected ACS

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

BIC-8

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Acute chest pain is commonly known to be the classic sign of a heart attack. Of the many patients which visit the Emergency Department because of chest pain, less than half do actually suffer from an acute heart attack or an acute narrowing of their coronary arteries, which - in an extreme case causes - the heart attack or myocardial infarction. In some patients the acute heart attack can be diagnosed immediately, either because of typical changes in their ECG or because of increased levels of the laboratory value Troponin in their blood. Troponin is currently the most important marker to diagnose acute coronary artery disease. Unfortunately we see a lot of patients with suspected acute coronary artery disease who 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 started on medical treatment until a second Troponin test after 6-9 hours is available.
We investigate a newly discovered biomarker, Copeptin. Copeptin has shown excellent results in clinical trials assessing its use in various acute diseases. There are two important trials showing the diagnostic use of Copeptin in patients with suspected acute coronary artery disease.
This trial compares two processes of managing patients with suspected acute coronary syndrome (ACS). 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 process).
We want to test Copeptin in patients with suspected acute coronary artery disease 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 cardiologists.Copeptin positive patients will be managed according to standard guidelines for the management of patients with ACS.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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 is a newly discovered biomarker which reflects the body's individual stress level. 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 personell) or an interventionell group (Copeptin testing, further management dependent on Copeptin result).
In this interventionell 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 controll group).
We 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. Our study design will not only assess the diagnostic use but also the clinical relevance of Copeptin testing in the ED/CPU.
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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000276
  •   2010/11/17
  •   2011/10/25
  •   yes
  •   Approved
  •   EA2/085/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1118-1665 
  •   NCT01498731  (ClinicalTrials.gov PRS)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I20 -  Angina pectoris
  •   I20-I25 -  Ischaemic heart diseases
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Experimental Arm:
    Patients who test negative for Copeptin at admission will be considered low-risk and will be discharged home without further interventions.
    To secure the patients safety they will be transferred into our co-operating network of resident cardiologists using the software "Praxis-connect" i.e. these patients will be discharged with an electronically booked appointment to see a cardiologist preferably the next day (but latest within the next three days). In case of any findings suggestive of acute coronary syndrome or worsening of the patient's condition, the patient will immediately be re-admitted to our Emergency Room.
    Patients who test positive for Copeptin will be treated as by standard practise.
  •   Control Arm:
    Patients will be managed as by standard practice abiding current guidelines for the management of patients with suspected ACS.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Safety effectivity endpoint: Proportion of MACE (all- cause death or survived sudden cardiac arrest, myocardial infarction, re-hospitalisation for acute coronary syndrome, acute unplanned PCI, coronary artery bypass grafting (CABG) and documented life-threatening arrhythmias (VF, VT, AV-block III)) within 30 days Copeptin vs. Control arm (non-inferiority).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Efficiency endpoint of proportion of patients in whom coronary angiography is performed copeptin vs. control arm.
Proportion of patients requiring PCI due to their findings in cardiac catheterization copeptin vs. control arm. (Assessment of Copeptin as a rule-in marker)
Further secondary endpoints evaluate efficacy, safety, cost effectiveness and patient satisfaction of the new process including length of stay in the hospital.
All-cause death, survived sudden cardiac arrest, myocardial infarction, re-hospitalisation for acute coronary syndrome, acute unplanned PCI, coronary artery bypass grafting (CABG) and documented life-threatening arrhythmias (VF, VT, AV-block III) at 30 and 90 days.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/04/13
  •   892
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Admission to the Emergency Department with symptoms consistent with ACS:
- Typical chest pain (with or without ECG-changes, but no ST-elevation) suggestive of unstable angina or non-ST-elevated myocardial infarction (NSTEMI)
- Troponin negative at admission according to the current clinical practice
Patient willing and able to give written informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients with ST-elevation myocardial infarction (STEMI)
Continuing chest pain or recurrent episodes of chest pain under therapy
High-risk patients with suspected ACS who need to be hospitalized for reasons independent of their initial troponin result
Patients who need to be hospitalized for other medical reasons
Patients in need of urgent life-saving interventions
Patients under 18 years of age
Patients with a life expectancy < 6 months
Patients with any condition that leads the treating physician to not consider the patient eligible for the trial

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Berlin, Arbeitsbereich Notfallmedizin CVK und CCM
    • Mr.  Prof.  Martin  Möckel 
    • Augustenburger Platz 1
    • 13353   Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Charité - Universitätsmedizin Berlin Campus Virchow Klinkum Med. Klinik m.S. Kardiologie Internistische Notaufnahme
    • Ms.  Dr. med.  Julia  Searle 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité - Universitätsmedizin Berlin Campus Virchow Klinikum Med. Klinik m.S. Kardiologie Internistische Notaufnahme
    • Ms.  Dr. med.  Julia  Searle 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • B.R.A.H.M.S.
    • Mr.  Dr.  Joern Ole  Vollert 
    • Neuendorfstrasse 25
    • 16761  Hennigsdorf
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/06/24
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.