CULPRIT-SHOCK

CULPRIT-SHOCK Advisory Boards

CULPRIT-SHOCK is supported by three advisory boards – the Scientific Advisory Board, the Data and Safety Monitoring Board (DSMB) & Ethical Advisory Board  and  Clinical Event Committee (CEC). These boards shall not only ensure the highest standard of research and monitor the progress of the project by taking part in the annual meetings, but will also ensure the compliance with all necessary ethical regulations. Whenever appropriate, they will consult the consortium and make recommendations on how to best improve project performance.

 

Scientific Advisory Board (SAB)

Members: The Scientific Advisory Board consists of 4 experts:

  • Prof. Dr. Christopher Granger, USA
  • Prof. Dr. E. Magnus Ohman, USA
  • Prof. Dr. Harvey D. White, New Zealand
  • Prof. Dr. Steen Dalby Christensen, Denmark

representing the key aspects of activities of the project, as indicated by the WP. As such, the Scientific Advisory Board Members represent leaders in the field of cardiogenic shock and the treatment of acute coronary syndromes.

 

Tasks: The Scientific Advisory Board will ensure a high standard of research and monitor the progress of the project.

 

 

 

Data and Safety Monitoring Board (DSMB) & Ethical Advisory Board

Members: For the overall CULPRIT-SHOCK project there is an established European Data Safety Monitoring Board (DSMB) with confirmed participation by an independent statistician and two experienced cardiologists in the field of cardiogenic shock treatment. The DSMB will also serve as ethical advisory board given their extensive expertise in cardiogenic shock treatment.

 

Tasks: The DSMB will ensure a high standard of research and monitor all safety aspects of the trial and will also check for the progress of the project. Safety assessment mainly includes bleeding, occurrence of stroke and the primary outcome with respect to mortality and severe renal failure. In addition, the DSMB will critically assess the results of the interim analysis for the primary study endpoint as well as for safety endpoints.

 

Clinical Event Committee (CEC)

Independent trial oversight will be performed by an established and confirmed clinical event committee. It is intended that the CEC meets four times to assess the clinical endpoints; once after the first interim analysis, after the finalization of the trial to assess the 30-day follow-up, after 6-month follow-up is completed and after 12-month follow-up is completed. Clinical endpoint adjudication will be performed using treatment arm blinded source data that are provided by the IHF to the CEC.

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