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NCT07553650Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 9 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
12750 (estimated)
First submitted
13 Apr 2026
Start date
27 Jul 2026
Primary completion date
30 Jun 2030
Lead sponsor
Charite University, Berlin, Germany
Diseases
Stroke
NCT number
NCT07553650

What you commit to

  • Study type: Observational
  • Planned participants: 12750
  • From 27 Jul 2026 to the primary completion date, 30 Jun 2030
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • In-hospital stroke
  • Stroke as a complication of a medical procedure
  • Already enrolled in the SN STROKE base cohort

Other

  • TIA
  • SAH
  • Enrolment in a randomised placebo-controlled interventional trial

Who the study is looking for

  • Diagnosis of AIS or ICH; the AIS diagnosis may be diagnosed clinically or radiologically (i.e., focal neurological impairment of sudden onset, lasting more than 24 hours and of presumed vascular origin, or with proof of cerebral ischaemia corresponding to the clinical symptoms in neuroimaging); for ICH diagnosis requires clinical symptoms and radiological diagnosis of ICH
  • Hospital admission \<24h after symptom onset
  • Age 18+ years for the basic Modules AIS and ICH; age \<18 years for the basic Module paediatric stroke patients
  • Informed consent: Signed IC from patients capable of giving consent and understanding all content of the IC or IC of an appropriate patient representative or deferred consent, if patients are unable to consent themselves
  • Additional inclusion criteria are defined by the individual Modules

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charité University, Berlin, Germany
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BerlinGermanyUnknown status
Universität Bielefeld, Universitätsklinikum OWL, Evangelisches Klinikum Bethel gGmbH,
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BielefeldGermanyUnknown status
Universitätsklinikum Carl Gustav Carus Dresden
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DresdenGermanyUnknown status
Universitätsklinikum Erlangen
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ErlangenGermanyUnknown status
Universitätsklinikum Essen
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EssenGermanyUnknown status
Universitatsklinikum Hamburg-Eppendorf (UKE)
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HamburgGermanyUnknown status
Universitätsklinikum Heidelberg
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HeidelbergGermanyUnknown status
Universitatsklinikum Leipzig
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LeipzigGermanyUnknown status
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck
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LübeckGermanyUnknown status
Ludwig Maximilians Universität Klinikum
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MünchenGermanyUnknown status
Universitätsklinikum Tübingen
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TübingenGermanyUnknown status
Universitätsklinikum Würzburg
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WürzburgGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.