In the Europe-wide Cardioproof study, the cardiac center is opting for TrialComplete in order to be able to implement the study findings using effective processes. The web-based study portal TrialComplete allows researchers at the participating centers to enter and analyze study and image data, and to carry out quality assurance, regardless of location. Thanks to the Deutsche Telekom computing centers, access to the portal is easy and secure for all participants, while a professional team looks after data privacy.
TrialComplete allows the German Heart Center Berlin to maintain an infrastructure for its Cardioproof study, which supports the study process effectively.
Then comes the simple implementation of the study design with the option to test it in depth under real conditions ahead of actual implementation. During the course of the study, image data can be entered in the collection center, assigned to the relevant test subject session, and filed. A centralized quality assurance approves the image data before it is assessed in other centers using the integrated viewer or as an export in specific, sometimes experimental, software systems and the result is filed in the right context in TrialComplete. This ensures that not only is the entire study process consistently documented in a system but that the image documents belonging to the study are integrated. The correlation between image and other study data therefore remains even after the study has been concluded. Both are available for subsequent use, enabling further knowledge to be generated from the available data with little effort.
The portal solution TrialComplete is immediately available, scalable to meet requirements, and simple to use – this considerably simplifies the management of studies and once again allows me to dedicate myself to more substantive issues.
As a top-class medical center with international cooperation partners, the DHZB carries out a wide range of research activities. The DHZB is scientifically broad-based and covers the entire range of diagnostic and therapeutic procedures. The increasing importance and further development of imaging is a major focus here. Non-invasive imaging such as those used in the EU Cardioproof study are an important cornerstone of this. Cardioproof is being coordinated by DHZB and is being carried out with the participation of partners in the UK, France, Italy, and Austria.
The Cardioproof study investigates innovative imaging and evaluation technologies, whereby the images pass through different pathways from the collection center to the assessment. A key concern is to ensure that, after initial allocation to the test subject, the images are reliably processed further in their context without media interruptions thereby maintaining allocation of images to test subjects at all times. A further challenge was implementing a solution which is adequately able to capture and prepare the images and make them available in a decentralized manner such that the data exchange is designed to be simple and secure.
TrialComplete represents a platform for image-based clinical studies with the necessary functionalities such as role and rights concepts or audit trails. It allows a study design to be easily mapped in the user interface. TrialComplete takes the image material and integrates it into the right context within the study without media interruptions. Sophisticated split and merge functions also offer the option to prepare complex image data sets in a way that is suitable for the application before they are approved by an expert for further use. TrialComplete is therefore in a position to record DICOM data from a wide range of modalities and manufacturers, view it in the integrated DICOM viewer and measure it. After the study has finished, the image data is also reliably available in context for subsequent use.
The use of TrialComplete as Software as a Service, operated in the highly secure computing centers at Deutsche Telekom in Frankfurt, also relieves the DHZB of complex network adaptations which would require the secure exchange of image data between the participating external partners operating in an in-house computing center.
The German Heart Center Berlin (DHZB) was founded in 1986 as a foundation under civil law. In its charter, the DHZB aims “...to achieve exceptionally high quality in the field of cardiac surgery and cardiology and ensure state-of-the-art development”. Up to 3,500 open-heart operations are carried out every year using the heart-lung machine. In the three cardiac catheter laboratories, more than 4,000 cardiac catheter examinations are also carried out every year. Of these, more than 2,000 are highly complex interventions such as heart valve replacements using catheter technology. Two high-performance MRI machines, a CT scanner and a wide range of the latest echocardiogram devices are available for non-invasive specialized diagnostics.
An important focus of the DHZB is also congenital heart defects, for which all age groups are treated – from newborns to pensioners. With 400 operations per year and around 700 cardiac cardiac examinations, the clinic is up there with the best in Germany and Europe for congenital heart defects and pediatric cardiology. The German Heart Center Berlin is very well connected, both in Germany and internationally. There are now more than 50 cooperation agreements and similar arrangements with heart clinics, also abroad, predominantly in China but also in Eastern Europe and in the Asia-Pacific region.