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  • Northern Shanghai Study II: systematic assessment and management of early organ damage and its role in preventing and reducing cardiovascular risk—protocol of a prospective study

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Cardiovascular medicine
Protocol
Northern Shanghai Study II: systematic assessment and management of early organ damage and its role in preventing and reducing cardiovascular risk—protocol of a prospective study
  1. Jingjing Hou1,
  2. Moran Li1,
  3. Jun Han1,
  4. Shikai Yu1,
  5. Xinming Jia2,
  6. Fenyong Sun3,
  7. Yi Zhang1
  1. 1Department of Cardiology,Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China
  2. 2Clinical Medicine Scientific and Technical Innovation Center,Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China
  3. 3Department of Clinical Laboratory Medicine,Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China
  1. Correspondence to Dr Yi Zhang; yizshcn{at}gmail.com

Abstract

Introduction Cardiovascular diseases are the leading cause of death and disease burden in China. However, there is a lack of prospective cohort studies suitable for evaluating early organ damage and its role in preventing and reducing cardiovascular risk among Chinese residents. This study intends to establish the first database based on the phenotypes of all early structural and functional damage of cardiovascular organs in Chinese population. Moreover, a digital follow-up mechanism will be formed, a prospective population cohort will be established, a biological sample bank for early cardiovascular organ damage will be established, and an intervention and management system for early damage of cardiovascular organs will be explored.

Methods and analysis This study is a prospective cohort study built on the foundation of the Northern Shanghai Study I. People aged 18–75 years are enrolled. After the recruitment, first, corresponding physical measurements and clinical examinations are conducted to collect cardiovascular risk factors and establish the demographic baseline of the study population. Next, the latest equipment is used to evaluate early structural and functional cardiovascular organ damage including heart, macrovessels, microcirculation, renal function and fundus. Meanwhile, the blood, urine, faeces and other biological samples of participants are collected to establish the cardiometabolic and gut microbiota analysis databases. The population is followed up every 2 years. Comprehensive assessment of early organ damage will be used to predict cardiovascular risk, guide people to change lifestyles to achieve early prevention and provide corresponding treatment recommendations.

Ethics and dissemination This study was approved by the Shanghai Tenth People’s Hospital Institutional Review Board. All participants signed a written consent form. The results of this study will be disseminated in peer-reviewed journals. Ethics approval: SHYS-IEC-5.0/22k148/P01.

Trial registration number NCT05435898.

  • Coronary heart disease
  • Cardiac Epidemiology
  • Hypertension
  • Coronary intervention
  • Adult cardiology
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-2023-073423

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    Footnotes

    • Contributors JJH, ML, JH, SY and YZ acquired the original data for this study. JJH contributed to the drafting of the manuscript. ML and JH helped us with the writing and language review. SY provided formulated the methods. XJ, FS and YZ conceived of and designed the protocol. All authors have taken part in writing and revising the manuscript, and have given their approval for the final version to be published.

    • Funding This work was financially supported by the Science and Technology Commission of Shanghai Municipality (Grant No. 20dz1207200).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.

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

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.