Clinical Research Directory

Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke)(Stroke-CORE)

The Stroke-CORE cohort aims to provide a comprehensive and up-to-date understanding of stroke care in Germany. To achieve this, patients are followed along the entire continuum of care-from initial management before hospital admission, through acute treatment, rehabilitation, and follow-up care, to the prevention of recurrent strokes. Strokes occurring in childhood are also included in this cohort study. In addition, the study seeks to establish effective structures for the early identification and inclusion of patients in clinical research (screening). In this context, structured screening processes are being implemented across all levels of care at participating sites within the Network University Medicine (NUM), a collaboration of German university hospitals. At the same time, the cohort serves as a platform within this network to systematically address open research questions in various areas of stroke care and to support the targeted planning and conduct of future clinical studies. The study includes patients with ischemic stroke (caused by a blocked blood vessel) or intracerebral hemorrhage (bleeding within the brain). Participation takes place in different thematic modules, each focusing on specific aspects of the disease course and its management. These modules address, among other topics, acute hospital treatment, measures to prevent recurrent strokes (secondary prevention), possible complications, pre-hospital care, rehabilitation, follow-up care, and long-term outcomes such as physical recovery, independence in daily life, and cognitive functions including memory and concentration. As part of the study, a range of data is collected. This includes sociodemographic information (such as age and living situation) as well as medical data, for example on prior conditions, diagnoses, treatments, and comorbidities. In addition, patients' health status is assessed at multiple time points in order to better understand the course of the disease. Depending on the level of participation, data collection may be complemented by the collection of biological samples, such as blood. These are obtained either during routine clinical procedures or through simple, minimally burdensome (non-invasive) methods. The study is structured into several levels that differ in the scope and depth of data collection. The basic level includes essential information, while higher levels involve more detailed assessments. In addition, some levels include the collection of biological samples, and there are optional supplementary modules in which patients may participate voluntarily. This tiered approach allows participation to be flexibly adapted to the individual situation while contributing to a nuanced and comprehensive understanding of stroke care.

High Dose Steroids in Children With Stroke

This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition. Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease. Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this. Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment. The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone. This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.