Trial document





This trial has been registered retrospectively.
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  DRKS00000274

Trial Description

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Title

Biomarkers in Cardiology (BIC) -4: The influence of cardiac biomarker testing on the sensitivity and specificity of stress ECG-testing in patients with coronary artery disease

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Trial Acronym

BIC-4

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URL of the Trial

http://www.charite.de/kardiologie/KCVK-Studien/

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Brief Summary in Lay Language

We test patients with suspected coronary artery disease (CAD) who undergo a bicycle stress ECG for various new cardiac laboratory parameters (biomarkers), which have shown promising results in clinical trials evaluating their diagnostic and prognostic use in CAD. Blood samples are drawn just before the stress ECG, 30 minutes after and 8-24 hours after the stress ECG. The aim of the trial is to investigate whether cardiac biomarkers can enhance the validity of stress ECG testing in order to diagnose CAD more accurately.

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Brief Summary in Scientific Language

We investigate whether the testing for new cardiac biomarkers enhances the validity of stress ECG testing. The hypothesis is that single cardiac biomarkers or biomarker profiles will enhance the sensitivity and/or specificity of stress ECG testing (ergometry), so that the diagnosis of cardiac ischemia due to coronary artery disease can be confirmed quickly and non-invasively. Patients could thereby directly be transferred to appropriate treatment, avoiding additional, often invasive diagnostic tests. The following biomarkers will be tested: Whole blood Choline, Plasmacholine, Copeptin, Myeloperoxidase (MPO) and sensitive Troponin I. Additionally we will collect retain samples to test for new, promising and yet unknown biomarkers.
The ergometry is a non-invasive, cost-effective and therefore widely-used method for the initial diagnostic investigation in patients with suspected coronary ischemia and is also used for clinical monitoring and therapy control. The validity of ergometry is not optimal, 20-30% of patients show false negative or false positive test results. For health economic (cost-effective) as well as patient-related (non-invasive) reasons it would be desirable to enhance the validity of the ergometry. We believe that it is possible to achieve this goal with additional testing for cardiac biomarkers or biomarker profiles.
All patients who are transferred to the study site for ergometry within the estimated 18 months study period will be registered. We will enroll all patients with suspected cardiac ischemia due to typical symptoms or a typical risk profile. Patients will have a blood draw of 20 mL just before the ergometry and 30 minutes and 8-24 hours after the ergometry. Relevant clinical data will be recorded in a special case report form. In patients who undergo coronary angiography after a positive or uncertain test result the angiography result will be documented. Patients will have a telephone follow-up after 6 months investigating survival and re-hospitalisation.
All blood samples will be processed within 2 hours and will be frozen at -70°C for later use.

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Organizational Data

  •   DRKS00000274
  •   2009/12/17
  •   [---]*
  •   yes
  •   Approved
  •   EA2/042/08, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1112-8738 
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Health Condition or Problem studied

  •   I20 -  Angina pectoris
  •   I25 -  Chronic ischaemic heart disease
  •   I24 -  Other acute ischaemic heart diseases
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Interventions/Observational Groups

  •   Bicycle stress-test because of a justified suspicion of cardiac ischemia is the non study-related test which qualifies patients for the trial and is carried out according to current guidelines of the German Society of Cardiology. Patients are transferred to the study site by their GP. Blood sampling just before, 30 minutes after and 8-24 hours after ergometry. Blood samples are frozen for later biomarker testing.
    Amount of blood per sample: 19 ml (2ml EDTA-wholeblood, 8.5ml Lithium-Heparin Plasma, 8.5ml EDTA-Plasma)
    Telephone Follow-up after 6 months to assess "survival" and re-hospitalisation. In case of re-hospitalization further data will be retrieved from the patient file.
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Characteristics

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

Proof of a coronaryx stenosis in which treatment is rquired. This will be assessed by obtaining the report of the coronary angiography in case that in the follow-up the patient reports coronary angiography following the result of his stress test. Information about a coronary angiography will also be obtained via the patients GP.

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Secondary Outcome

MACE at 90 days
Cardiovascular death
Re-hospitalisation for suspected acute coronary syndrome or congestive heart failure
Acute Myocardial Infarction (AMI)
Acute unplanned PCI
CABG
Documented life-saving arrhythmias or survived sudden cardiac arrest
Assessment in 6 months-follow-up, in case of re-hospitalization patient documents will be requested || Development of Choline levels before ans after stress test (Whole blood and plasma choline). Blood sampling immediately before stress test, 30 minutes after the stress test and 8-24 hours after the stress test. For whole blood choline whole blood samples remain at room temperature for 30 minutes after withdrawal and are then frozen at -20°C, within a maximum of 14 days at -80°C. For plasma choline plasma is stored on ice immediately after withdrawal and is processed within a maximum time of 2 hours until freezing. All samples are analyzed en bloc after the whole trial data set has been completed. The test assay will be chosen after the data set is complete. || Development of Copeptin levels before and after stress test. Time points for the blood draws see above. For Copeptin analysis EDTA plasma is stored on ice immediately after withdrawal and is processed within a maximum time of 2 hours until freezing. Samples are frozen at -20°C, within a maximum of 14 days at -80°C. All samples are analyzed en bloc after the whole trial data set has been completed. Copeptin will be measured using the BRAHMS sandwich immune-luminometric assay. || Development of sensitive Troponin I levels before and after stress test. Time points for the blood draws see above. For sensitive Troponin EDTA plasma is stored on ice immediately after withdrawal and is processed within a maximum time of 2 hours until freezing. Samples are then frozen at -20°C, within a maximum of 14 days at -80°C. All samples are analyzed en bloc after the whole trial data set has been completed. An appropiate assay for the analysis will be chosen after the data set is complete. || Development of Myeloperoxidase-levels before and after stress test. Time points for the blood draws see above.Processing of blood samples as described above.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/06/24
  •   300
  •   Multicenter 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 is willing and able to give written informed consent
-Indication for ergometry for the diagnosis of cardiac ischemia:
Coronary artery disease-specific signs and symptoms and/or at least to of the following risk factors for coronary artery disease:
-Diabetes mellitus
-Arterial hypertension
-Hyperlipidemia
-Smoking
-positive family history of CAD

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Exclusion Criteria

Patient is not able to conduct the study due to his/her health status
Ergometry indicated for non-CAD related reasons
Detention by law

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Addresses

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    • Charité - Universitätsmedizin Berlin Campus Virchow Klinikum Med. Klinik m. S. Kardiologie
    • Mr.  Prof. Dr.  Martin  Möckel 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin Campus Virchow Klinikum Medizinische Klinik m.S. Kardiologie
    • Ms.  Dr. med.  Julia  Searle 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Facharztpraxis für Innere Medizin
    • Mr.  Dieter  Gälke 
    • Dorfstrasse 33
    • 16227  Eberswalde
    • Germany
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    •   0049 (0)3334 355634
    •   0049 (0)3334 355636
    •   Chilai at t-online.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Charité - Universitätsmedizin Berlin Campus Virchow Klinikum Med. Klinik m.S. Kardiologie
    • Mr.  Prof. Dr.  Martin  Möckel 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.