Protocol for Multi-modality MEdical imaging sTudy bAsed on KaiLuan Study (META-KLS): rationale, design and database building

INTRODUCTION: Multi-modality medical imaging study, especially brain MRI, greatly facilitates the research on subclinical brain disease. However, there is still a lack of such studies with a wider age span of participants. The Multi-modality MEdical imaging sTudy bAsed on KaiLuan Study (META-KLS) was designed to address this issue with a large sample size population. METHODS AND ANALYSIS: We aim to enrol at least 1000 subjects in META-KLS. All the participants without contraindications will perform multi-modality medical imaging, including brain MRI, retinal fundus photograph, fundus optical coherence tomography (OCT) and ultrasonography of the internal carotid artery (ICA) every 2–4 years. The acquired medical imaging will be further processed with a standardised and validated workflow. The clinical data at baseline and follow-up will be collected from the KaiLuan Study. The associations between multiple risk factors and subclinical brain disease are able to be fully investigated. Researches based on META-KLS will provide a series of state-of-the-art evidence for the prevention of neurological diseases and common chronic diseases. ETHICS AND DISSEMINATION: The Kailuan Study and META-KLS have been approved by the Medical Ethics Committee of Kailuan General Hospital (IRB number: 2008 No. 1 and 2021002, respectively). Written informed consent will be acquired from each participant. Results are expected to be published in professional peer-reviewed journals beginning in 2023. TRIAL REGISTRATION NUMBER: NCT05453877.