Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000310

Trial Description

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Title

Biomarkers in Cardiology
BIC-1

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Trial Acronym

BIC-1

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We want to establish a database with blood samples of healthy patients (BIC-1) as well as blood samples of patients with functional heart disorder (BIC-2). We will use those blood samples to find new biomarkers, like enzymes and messengers, and to figure out, if those biomarkers can help to advance risk analysis, diagnostic and hence also therapy of chronical heart diseases (cardiac insufficiency and cardiac infarction).
BIC-1 involves the collection of blood samples and data of 300 supposedly healthy Charité members of staff.

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Brief Summary in Scientific Language

Primary objecitve of this study is the establishment of a database with blood samples from healthy patients (BIC-1) as well as patients of the emergency department with the cardinal symptoms of cardiological diseases: dyspnea and chest pain (BIC-2). Those blood samples will be analyzed to identify and evaluate new relevant biomarkers for risk analysis and diagnostic in cardiology.
Beneath others we will evaluate the following biomarkers:
Myoeloperoxidaxe, Plexental Growth Factor (PIGF), whole blood choline, hight sensitivity Troponine I.

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Organizational Data

  •   DRKS00000310
  •   2011/03/23
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  •   yes
  •   Approved
  •   EA2/030/07, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1119-7510 
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Health Condition or Problem studied

  •   I21 -  Acute myocardial infarction
  •   I50 -  Heart failure
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Interventions/Observational Groups

  •   Blood draw (50 mL), vital signs, assessment cardiovascular risk factors
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
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Primary Outcome

/

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2007/06/06
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Patient full of age, healthy and able to sign informing consent

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Exclusion Criteria

- cardiovacular and metabolic diseases
- no adequate employment agreement (e.g. trainee, student)
- dependency from director of studies
- Hospitalization according to official or judicial order

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Addresses

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    • Charité Berlin, Arbeitsbereich Notfallmedizin CVK und CCM, Medizinische Klinik m.S. Kardiologie
    • Mr.  Prof.  Martin  Möckel 
    • Augustenburger Platz 1
    • 13353   Berlin
    • Germany
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    • Charité Berlin Medizinische Klinik m.S. Kardiologie
    • Ms.  Dr.  Julia  Searle 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Campus Virchow Klinikum Medizinische Klinik m. S. Kardiologie Internistische Notaufnahme
    • Ms.  Dr. med.  Julia  Searle 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Abbott Deutschland
    • Max-Planck-Ring 2
    • 65205  Wies­baden
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2007/11/29
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.