Early monitoring of intravenous thrombolysis in acute ischaemic stroke using wearable intelligent vital sign devices: protocol for a prospective, multicentre, observational registry cohort study

Abstract

Introduction Continuous monitoring of vital signs during and after ischaemic stroke was recommended by the ‘Guidelines for the Early Management of Patients with Acute Ischaemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischaemic Stroke’. Vital sign data can be associated with disease conditions and prognosis, while there is limited evidence regarding continuous monitoring of vital signs during and after acute ischaemic stroke. The wearable intelligent vital sign monitoring device is small and lightweight and constantly monitors the health status during daily activities. However, wearable intelligent vital sign monitoring devices have not been widely used in clinical practice so far. Therefore, we will investigate the effectiveness and safety of wearable intelligent vital sign monitoring devices in early in-hospital management and monitoring programmes for patients with acute ischaemic stroke. This paper presents the study protocol.Methods and design This study is a prospective, multicentre, observational registry study starting from 20 March 2023 to 20 March 2025. A total of 5740 patients with acute ischaemic stroke from 10 Chinese hospitals are planned to be enrolled. Continuous vital sign data, demographics, medical history, medication history, treatments, laboratory tests, imaging scans and follow-up data will be collected. Follow-up time points were 30 days after discharge, 30 days after intravenous thrombolysis, 3 months after intravenous thrombolysis and 12 months after intravenous thrombolysis (until March 2026). The primary outcome included the evaluation of the modified Rankin Scale at 3 months, as well as the assessment of the rate of symptomatic and asymptomatic intracranial haemorrhage throughout the hospitalisation period.Ethics and dissemination This study has been approved by the Medical Ethics Committee of Xuanwu Hospital, Capital Medical University ([2022] 203). We plan to disseminate the research findings through publication in peer-reviewed scientific journals and presentations at international conferences.Trial registration number ChiCTR2300069512.