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Case Study: How to send angiograms in DICOM format in investigator-initiated multicenter coronary stent study COMPARE 60/80 HBR

The collection of medical images often plays a vital role to analyze the efficiency of new treatment options researched in clinical studies. The safe and regulatory compliant transfer of DICOM images from the participating sites to the Corelab must be realized in a user-friendly manner. A special challenge is the typically small budgets available for investigator-initiated studies and still, a regulatory compliant way has to be found to get the medical images from A to B. The study management from the Cardio Research Department Maasstad Hospital, Rotterdam, of the COMPARE 60/80 HBR investigator initiated, multicenter, randomized clinical trial have chosen ClinFlows’ web based dicomdrop-solution to safely collect the angiograms from the 11 participating sites in the Netherlands enrolling 736 patients.

Client:

Cardio Research Department Maasstad Hospital, Rotterdam, the Netherlands supported by a grant of SMT (Sahajanand Medical Technologies Pvt. Ltd), a leading global developer and manufacturer of minimally invasive cardiovascular devices. The study is sponsored by the Research Maatschap Cardiologen Rotterdam Zuid, associated with the Maasstad Ziekenhuis Rotterdam, the Netherlands.

Project:

Investigator-initiated, multicenter, randomized controlled study, COMPARE 60/80 HBR: Comparison of the Supraflex Cruz 60 micron stent strut versus the Ultimaster Tansei 80 micron stent strut in a High Bleeding Risk PCI population.

Project Background:

In PCI patients at high bleeding risk (HBR), international guidelines recommend a shorter duration of dual antiplatelet therapy (DAPT). While this reduces the risk of bleeding, it may also increase the risk of stent thrombosis and ischemic events. The solution for PCI patients with HBR could be the use of ultrathin stent struts, as these may reduce ischemic events with a shorter duration of DAPT. COMPARE 60/80 HBR was initiated to investigate just this. From 2020 to 2023, under the leadership of Pieter Smits, M.D., Maasstad Ziekenhuis, Study Chairman and Principal Investigator, PCI use of the ultra-thin stent strut (60 µm) Supraflex Cruz will be compared with use of the thin strut (80 µm) Ultimaster Tansei among 736 patients with HBR. The study results may open new treatment options for PCI patients with HBR. Patients are followed for 12 months.

Challenge:

All angiograms of the index procedures, or any planned staged or unplanned procedures have to be sent to the Cardio Research Department in Rotterdam by the 11 participating sites. CERC Europe, Paris, France, will perform the analysis of the angiograms. The challenge was to find a very cost-effective and easy-to-use DICOM transfer tool, which provides an automated pseudonymization of DICOM tags and meets all GDPR requirements. 

Solution:

For the safe transfer of the DICOM images, the Cardio research team of Maasstad Hospital has chosen ClinFlows’ web-based solution dicomdrop since the start of the COMPARE 60/80 HBR study. With just a few clicks, the eleven participating sites can use the platform to send their angiograms in DICOM format to Rotterdam in a very uncomplicated, fast, and GDPR-compliant way thanks to the integrated pseudonymization options. The application allows the coordinator to create a project within dicomdrop and to invite the participating sites to join the project. The sites can enter a case reference which is automatically inserted in the uploaded DICOM tags, to assure clear subject identification. The coordination team in Rotterdam receives a download link to collect the data, which are only stored on ClinFlows high-end, high-security servers in Europe. All uploaded data are automatically deleted from the dicomdrop-servers after ten days to minimize the risk and assure a high-end data privacy protection. All the sites have to do is to register on dicomdrop once in order to upload DICOMs within the Compare 60/80 HBR project.

Result:

From 2020 until today, more than 700 patients have already been recruited in this study and around 800 angiographies have already been transferred via dicomdrop. 

Client feedback:

“For the success of our study, it is crucial to have a reliable and stable technology for online image transmission. Furthermore, the whole process has to be simple, fast and secure. dicomdrop fulfills exactly these points. We are happy to have relied on this tool from the very beginning of the study and thus to gain new insights for PCI patients with HBR as quickly as possible,” says Ria van Vliet, Project Manager at Cardio Research Department, Maasstad Ziekenhuis.

Want to learn more about how our clients benefit from our solutions in practice? Simply get in touch via info(at)clinflows.com or find out here, how a leading TAVI manufacturer manages case reviews and eligibility checks to serve clients and here, how to provide clinical decision support during post-training phase.

Image source: Freepik.com / pressefoto

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ClinFlows’ software helps children with heart disease across the globe

Congenital cardiac malformations are the main cause of death among children. Worldwide, more than 6 million children suffer from heart diseases, while 80 percent of newborns affected by these malformations do not survive in developing countries. Bambini Cardiopatici nel Mondo, an Italian nonprofit organization (NGO), works hard to change this condition. Along with other groups, the NGO leads medical missions abroad to visit, treat and operate on children affected by congenital heart diseases. Furthermore, it provides training and education to physicians and health personnel. 

Our platform supports global communication about children’s clinical cases

Our donation allows the NGO to use our web-based decidemedical online platform at no cost, benefiting children across the world. This software allows the NGO to share clinical data and medical images among various stakeholders involved in the treatment of children in various countries.

By using the platform, hospitals can submit cases with clinical information and medical images online. As soon as cases are uploaded, the medical team at Bambini Cardiopatici nel Mondo is notified, allowing the team to review and download the provided case information. With this information, case eligibility and treatment options can be discussed and advice provided – all centralized, remotely and quickly.

“This collaborative initiative allows us to further improve our activities aimed at treating and increasing life expectancy for children with heart diseases. At the same time, it helps us to develop distance learning and the real-time exchange of experience and training between doctors and healthcare professionals in developing countries where our association operates,” said Prof. Alessandro Frigiola, president of Bambini Cardiopatici nel Mondo. “The online application also improves the safety, accuracy and timeliness of diagnosis and follow-up for children who need our evaluation.” In total, as part of the donation for the NGO, up to 100 sites can participate and discuss 600 cases annually.

A real matter of the heart for us at ClinFlows

We are very impressed by the work done by the organization and its health professionals to help children with heart diseases around the world. In my first job, I worked as a perfusionist in the operating room, where I observed many children being operated on by skilled and passionate heart surgeons. Therefore, it is a real honor to contribute to this group’s efforts through the donation of our online solution to ease the work of Prof. Frigiola and these hard-working teams. In the truest sense of the word: this is a real matter of the heart for us.

About the author:

Uwe Gladbach is a biomedical engineer, who started his career as a perfusionist in open heart surgery back in the 90ties. In more than 25 years he gained experience in the medical device industry in various positions, covering clinical research, as well as sales and operations in global positions. Uwe is the CEO and founder of ClinFlows, which offers e-solutions for clinical workflows.