Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000309

Trial Description

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Title

Biomarkers in Cardiology
BIC-2

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Trial Acronym

BIC-2

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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). This part of the trial (BIC-2) involves the collection of blood samples and data of emergency patients with cardiovascular cardinal symptoms (chest pain and shortness of breath)

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Brief Summary in Scientific Language

We want to establish a database of healthy patients (BIC-1) as well as patients of emergency with the cardiological principal signs of dyspnea and chest pain (BIC-2). Those blood samples can be used 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

  •   DRKS00000309
  •   2011/03/21
  •   [---]*
  •   yes
  •   Approved
  •   EA2/030/07, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1119-7533 
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Health Condition or Problem studied

  •   I20-I25 -  Ischaemic heart diseases
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Interventions/Observational Groups

  •   Blood draw during emergency care/management.
    Dyspnea patients: 1 blood draw within 24h after admission.
    Chest pain: Blood draw within 2 hours after admission and again 6-10 hours after admission. Follow-up after 3 months with respect to mortality and re-hospitalization.
    No other study-related measures.
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Characteristics

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

The aim is the diagnostic and prognostic evaluation of biomarkers in cardiovascular diseases.
Primary endpoint for diagnosis is the main hospital diagnosis as documented in the final discharge letter (documentation in the eCRF)
Primary endpoint for prognosis is the 3 months mortality and re-hospitalization.

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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
  •   2008/02/18
  •   500
  •   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

- Patient of full age, able to sign informed consent and was inpatient for elective PTCA
- Patient has frequented emergency room due to leading symptoms chest pain and/or dyspnea

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Exclusion Criteria

- Redemption of consent
- Anemia < 10 g/dL
- Life expectancy < 6 months
- state of shock or acute disease patterrn
- age under 18 years
- Hospitalization according to official or judicial order

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Addresses

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    • Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Medizinische Klinik m.S. Kardiologie Internistische Notaufnahme
    • Mr.  Prof. Dr. med.  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 Universitätsmedizin Berlin Campus Virchow Klinikum Med. 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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    • Charité Berlin, Arbeitsbereich Notfallmedizin CVK und CCM, Medizinische Klinik m.S. Kardiologie
    • Mr.  Martin  Möckel 
    • Augustenburger Platz 1
    • 13353   Berlin
    • Germany
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    •   0049 (0)30 450 553472
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/12/31
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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.