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  • Development of cognition decline in non-acute symptomatic patients with cerebral small vessel disease: Non-Acute Symptomatic Cerebral Ischemia Registration study (NASCIR)—rationale and protocol for a prospective multicentre observational study

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Neurology
Protocol
Development of cognition decline in non-acute symptomatic patients with cerebral small vessel disease: Non-Acute Symptomatic Cerebral Ischemia Registration study (NASCIR)—rationale and protocol for a prospective multicentre observational study
  1. Shuting Zhang1,
  2. Zhetao Wang2,
  3. Peng Liu3,
  4. Qingzhang Tuo4,
  5. Yajun Cheng1,
  6. Mangmang Xu1,
  7. Qian Wu1,
  8. Peng Lei1,4,
  9. Lunzhi Dai4,
  10. William Robert Kwapong1,
  11. Mingying Tan5,
  12. Ming Liu1
  1. 1Department of Neurology, Sichuan University West China Hospital, Chengdu, Sichuan, China
  2. 2Department of Radiology, Sichuan University West China Hospital, Chengdu, Sichuan, China
  3. 3Department of Emergency, Sichuan University West China Hospital, Chengdu, Sichuan, China
  4. 4State Key Laboratory of Biotherapy, Sichuan University West China Hospital, Chengdu, Sichuan, China
  5. 5Outpatient Department, Sichuan University West China Hospital, Chengdu, Sichuan, China
  1. Correspondence to Professor Ming Liu; wyplmh{at}hotmail.com; Ms Mingying Tan; 1923602646{at}qq.com

Abstract

Introduction Headaches, dizziness and memory loss of unspecific causes are the most common non-acute ischemia symptoms in the ageing population, which are often associated with cerebral small vessel disease (CSVD) imaging markers; however, there is insufficient evidence concerning their association with the development of cognitive decline. This study aims to investigate risk factors, clinical course, cerebral and retinal imaging changes, proteomics features of non-symptomatic ischaemia symptomatic patients with cognitive decline.

Methods and analysis The Non-Acute Symptomatic Cerebral Ischemia Registration study is a multicentre, registry-based, prospective observational study, is designed to investigate the cognitive decline in non-acute ischaemia symptomatic patients. We will recruit 500 non-acute ischaemia symptomatic patients from four tertiary hospitals in China. For this study, non-acute ischaemia symptoms will be defined as headaches, dizziness and memory loss. Patients with headaches, dizziness or memory loss over 50 years of age will be included. Clinical features, cognitive assessment, cerebral and retinal imaging data, and a blood sample will be collected after recruitment. Patients will be followed up by structured telephone interviews at 1, 2, 3, 4, 5 years after recruitment. This study will improve our knowledge of the development of cognitive decline in non-acute ischaemia symptomatic patients and factors affecting the cognitive outcomes, which will eventually elucidate underlying pathways and mechanisms of cognitive decline in these patients and facilitate the optimisation of individualised interventions for its prevention and treatment.

Ethics and dissemination Ethics approval is obtained from The Biomedical Research Ethics Committee of West China Hospital, Sichuan University (Reference No. 2016 (335)). We will present our findings at national and international conferences and peer-reviewed journals in stroke and neurology.

Trial registration number ChiCTR-COC-17013056.

  • stroke
  • dementia
  • neuroradiology
  • neuro-ophthalmology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2021-050294

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    Footnotes

    • SZ, ZW and PL contributed equally.

    • Contributors ML and MT are the guarantor of the article. ML, MT, SZ design and conduct the cohort and wrote the paper. ML, MT and SZ are the grant holders. ML, SZ and MT conceive and design the study. SZ, ZW and PLiu conduct a systematic review of literature. SZ, ZW, PLiu, QT, YC, MX, QW, PLei, LD and WRK collect the data and construct the database. SZ, ZW and PLiu analysed the interpreted the data. All authors critically appraised the protocol. All authors have read and approved the final manuscript.

    • Funding This study was funded by the National Natural Science Foundation of China (81870859, 92049115), the National Key Research and Development Programme of China of the Ministry of Science and Technology of China (2016YFC1300500-505 and 2018YFC1312300-303), the 1.3.5 project for disciplines of excellence, West China Hospital, Sichuan University (ZYG D18009) and the Science & Technology Department of Sichuan Province (2018hhs-54, 2019YFS0385).

    • Disclaimer Study sponsors and funders play no role in the design and management of the study, collection, analysis and interpretation of data, writing of the report, or the decision on submitting the report for publication.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.