Abstract
Introduction: In Germany, stroke is the third leading cause of death, with more than 60,000 fatalities out of approximately 260,000 cases (first-ever and recurrent strokes) each year. So far, there are only a few long-term studies investigating determinants of the natural course of the disease, especially in the era of mechanical thrombectomy. Materials and Methods: The prospective single-center stroke cohort Augsburg (SCHANA) study will include about 1000 patients treated for stroke in the University Hospital of Augsburg. Patients aged 18 years or older with a confirmed diagnosis of ischemic or hemorrhagic stroke are included in the study. Information on demographic characteristics, onset of symptoms, etiologic factors, comorbidities, quality of life, invasive and non-invasive treatment, complications, and laboratory parameters are collected during a personal interview conducted during the patients’ hospital stay and via a medical chart review. About 30 mL of blood is collected from each patient, and after processing and aliquoting, all blood specimens are frozen at −80° C. The study participants will be followed-up via postal questionnaires at three and 12 months after discharge from the hospital. Furthermore, mortality follow-ups will be conducted. Cox-regression analysis will be used to estimate relative risks. Conclusion: The SCHANA study will generate comprehensive data on the long-term course of the disease. In addition to the main outcomes, recurrent events and survival, patient-oriented outcomes such as health-related quality of life and depression are the focus of the study.
Highlights
In Germany, stroke is the third leading cause of death, with more than60,000 fatalities out of approximately 260,000 cases each year.So far, there are only a few long-term studies investigating determinants of the natural course of the disease, especially in the era of mechanical thrombectomy
Baseline characteristics will be presented as mean ± standard deviation (SD) or as a median and Information on deaths occurring in the study sample during follow-up will be collected by interquartile range for continuous variables; categorical variables will be given as percentages
The protocol for a long-term prospective observational cohort study, including patients with acute stroke treated in a hospital, is presented
Summary
According to the World Health Organization (WHO), approximately 15 million people suffer a stroke every year. The current study can help to examine this in more detail in terms of long-term processes and may contribute to exploring bridging therapy in addition to advanced imaging-based approaches to select appropriate patients Both thrombolysis and mechanical thrombectomy result in an overall benefit regarding living without disability, but they do not improve survival [8,9]. A portion of patients develop complications after thrombolysis or thrombectomy [10,11], and the neurological recovery is dependent on the patient’s baseline functional status, as well as the status of the brain tissue, as assessed by brain imaging. Subgroup differences regarding treatment effects and patient outcomes such as long-term survival and recurrent events will be assessed. To estimate the impact of thrombolysis, mechanical thrombectomy and drug treatment, comorbidity, treatment-related complications on stroke-related long-term survival, and to examine the frequency and time point of recurrent events; to examine interaction effects between thrombolysis, mechanical thrombectomy and drug treatment on the outcome
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