Clinical treatment outcomes of acute ischemic stroke: protocol for a registry ambispective cohort study

Background and objectives: Many types of neuroprotective agents and traditional Chinese medicines are commonly used for the clinical treatment of ischemic stroke in China. However, there is no high-quality randomized controlled trial assessing efficacy and safety, and these medicines have not been recommended in the guidelines. Therefore, in this study, we will analyze the treatment outcomes of acute ischemic stroke in the clinic. Design: This is a registry, single-center, ambispective cohort study. Methods: The study will be conducted at the Shengjing Hospital of China Medical University, China. Data for 600 cases of acute ischemic stroke from October 2016 to November 2017 were retrospectively collected for trend analysis in January 2018. Furthermore, data for 1400 cases of acute ischemic stroke have been prospectively collected since February 2018. Stroke patients will be visited five times: on admission (baseline assessment, visit 1), during medication and treatment in the hospital (visit 2), at discharge (visit 3), 90 ± 14 days after treatment (outpatient clinic or telephone follow-up, visit 4), and 360 ± 28 days after treatment (telephone follow-up, visit 5). Outcome measures: Outcome measures will include vital signs, electrocardiogram, laboratory findings and imaging findings, Glasgow Coma Scale, Essen Stroke Risk Score, National Institutes of Health Stroke Scale, modified Rankin Scale, and adverse events. National Institutes of Health Stroke Scale score at discharge (visit 3) will be the primary outcome measure; the remainder will be secondary outcome measures. Discussion: This study of the clinical treatment and outcomes of acute ischemic stroke should help in optimizing clinical diagnosis and treatment. Ethics and dissemination: This trial was designed in October 2017. This trial has been approved by the Ethics Committee of Shengjing Hospital of China Medical University of China in December 2017 (approval number: 2017PS40K). This trial was registered in December 2017. Subjects with acute ischemic stroke from October 2016 to November 2017 were retrospectively recruited for trend analysis in January 2018. Other subjects began to be prospectively recruited from February 2018, and prospective collection will be finished within 36 months. Each subject will be followed up for 360 days. The follow-up will be completed in November 2021. Data analysis will be finished in November 2022. The results of the trial will be disseminated in a peer-reviewed journal. Trial registration: This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-OOC-17013773). Protocol version (1.0).