The ambulatory structured post-stroke care program – extended postinterventional follow up (SANO-EXTEND)

• Applicant: Professor Dr. Peter U. Heuschmann
• Subject Area: Clinical Neurology; Neurosurgery and Neuroradiology
• Term: since 2023
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 470538619

SANO-EXTEND is a post-interventional follow-up study of the recently finished Structured ambulatory post-stroke care program “(Strukturierte ambulante Nachsorge nach Schlaganfall (SANO)”) . The aim of SANO-EXTEND is to assess the long-term effect of the SANO-Study. SANO is a cluster-randomized trial running between 2018 and 2022 being funded by the Federal Joint Committee (G-BA) within the Innovation Fonds. From January 2019 to December 2020, 2791 participants have been successfully recruited to the SANO-Study in 30 participating centers across Germany. The study population consists of mild- to moderately affected primary ischemic stroke patients ≥ 18 years cognitively and physically able to follow the study intervention. Within the SANO-Study, the effect of a complex intervention consisting of the establishment of a regional cross-sectoral network of aftercare care providers and standardized follow-up visits for risk factor control and goal setting was assessed; the intervention was compared to usual care. After one year, all patients took part in a final assessment, during which the rate of the primary combined endpoint of recurrent stroke, myocardial infarction and death was assessed. However, several interventions of the SANO-Study, like statin therapy or dietary changes, are likely to have a long-term effect after the one-year intervention period regarding cardiovascular risk reduction. Therefore, in SANO-EXTEND a standardized structured telephone interview will take place after 4 years after the index event to assess the rate recurrent stroke, MI and death (primary endpoint) as well as the rate of rehospitalization, cardiovascular risk factor control according to predefined targets based on clinical guidelines and best available evidence, pharmaceutical treatment including prescription of antiplatelets or anti-coagulants, appropriate provision of assistive devices and therapy, quality of life, patient-reported outcome measures, event rates of transient ischemic attack as well as incidence and prevalence of stroke-related complications and their management according to guidelines (secondary endpoints). We hypothesize that the one-year intervention of the SANO-Study will have positive long-term effects in terms of decreasing the occurrence of recurrent stroke, myocardial infarction and early death as well as on reducing the frequency of complications after stroke up to 4 years after index stroke. The extension of the observational period to 4 years by the suggested observational trial SANO-EXTEND will thus overcome limitations of the original trial subject to the guidelines of the funding scheme and, therefore, yield more robust results.

• DFG Programme: Clinical Trials
• Co-Investigators: Dr. Azarakhsh Pankert; Dr. Christopher Schwarzbach