Partner 7 - ACTION
CULPRIT-SHOCK Team ACTION
Mrs. Karine Brochard
Clinical Trial Manager
ACTION is an Academic Research Organization, funded in 2007 by Prof. Dr. Gilles Montalescot (Intensive Care Unit and Cardiology Director and INSERM research unit on thrombosis; Director), Prof. Dr. Eric Vicaut (Clinical Research Unit Director) and Christophe Misse (DRCD director). Its main goal is to lead and conduct clinical trials to answer questions relevant to patients and physicians and which may help to better understand disease states
and/or impact clinical practice. ACTION provides extensive expertise in the fields of: global trial management, trial leadership, national and international clinical trials, biostatistics and data management, clinical event committees, data monitoring committees, central ECG, angiographic and genetic core laboratory and patient education.
ACTION has also served as an organization assisting clinical trials led by other groups. ACTION has established partnerships with many pharmaceutical industry companies and clinical centers in France and Europe. Over the last 4 years, ACTION has managed more than 15 projects (industry and investigator driven clinical trials) in the field of coronary artery disease, atherothrombosis and applied pharmacology. All projects have been performed on time successfully.
ACTION’s core laboratory has a strong experience in angiographic studies of national and international projects in the field of cardiovascular diseases. ACTION has managed for example the ATOLL core laboratory substudy.
ACTION’s knowledge and many years of experience in the cardiovascular field and its dedicated team will guarantee a top quality management for the angiographic substudy. The Core Laboratory is equipped with the infrastructure, personnel, and experience to meet the goals for any type of angiographic study.
ACTION will independently and blindly assess angiographic data of the CULPRIT-SHOCK trial. Angiogram acquisition will be performed according to “Angiographic Guidelines for optimal myocardial perfusion assessment”. All participating centers will be provided with a specific binder including transmittal forms, labels, and imaging acquisition guidelines. Centers will be asked to perform a quality test run at start to ensure acquisition guidelines are followed properly. All coronary angiograms will be blindly reviewed by two senior analysts of the ACTION Core Laboratory. Angiograms will be read using the Global Imaging DICOM viewer. CDs are archived in a dedicated place. Core lab analyses results are anonymized and stored in an electronic dedicated database sent to the data management centre.