Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000687

Trial Description

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Title

biomarkers in cardiology BIC-7
creation of a database of biomaterials with blood samples of unselected internistic patients

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Trial Acronym

BIC-7

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is to improve treatment and care in emergency rooms. For this purpose, we research for new biomarkers (in blood indentifiable laboratory values), that may help to identify early risks for or the existence of diseases of the coronary arteries and cerebral vessels and their complications and sequelae. For this we use blood leftover in the regular decrease of blood in the emergency diagnosis and their associated disease-related datas in a pseudonym (randomly assigned code number).

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Brief Summary in Scientific Language

The aim of this study is to build a database of biomaterials with bloodsamples from 1000 unselected internal emergency patients.These materials are intended identification and evaluation of new, in emergency medicine relevant biomarkers which used forrisk stratifikation and the in- and exclusion diagnosis of cardiovascular and cerebrovascular diseases and related disorders and complications without its own extensive, prospective study for each marker must be planned and implemented.

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Organizational Data

  •   DRKS00000687
  •   2011/03/21
  •   [---]*
  •   yes
  •   Approved
  •   EA2/121/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1119-7564 
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Health Condition or Problem studied

  •   Examination of routine blood tests on biomarkers
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   blood draw as part of emergency care and management, no further study-related measures
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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

Main hospital diagnosis. The main hospital diagnosis (ICD-10 code) will be retrieved from the SAP hospital information system (HIS) of the Charité after recruitment is complete.

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Secondary Outcome

Other hospital diagnoses (ICD-10 codes), In-hospital mortalirty, ICU-care, Length of stay (in hospital, in ED). All data will be retrieved from the HIS after recruitment is complete.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/12/22
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

adult patients
patients in the emergency department of internal medicine of the Campus Virchow Klinikum and Campus Charité Mitte

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Exclusion Criteria

Dependency ratio by the study leader
Accommodation in an institution of judicial or administrative order
underaged patients

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Addresses

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    • Charité Berlin, Arbeitsbereich Notfallmedizin CVK und CCM
    • 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 Berlin Medizinische Klinik m.S. Kardiologie
    • Ms.  Dr.  Julia  Searle 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • BRAHMS/Thermofisher
    • Neuendorfer Straße 24
    • 16761  Henningsdorf
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/11/28
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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.