Pivotal trial of a deep-learning-based retinal biomarker (Reti-CVD) in the prediction of cardiovascular disease: data from CMERC-HI.

Journal: Journal of the American Medical Informatics Association : JAMIA
PMID:

Abstract

OBJECTIVE: The potential of using retinal images as a biomarker of cardiovascular disease (CVD) risk has gained significant attention, but regulatory approval of such artificial intelligence (AI) algorithms is lacking. In this regulated pivotal trial, we validated the efficacy of Reti-CVD, an AI-Software as a Medical Device (AI-SaMD), that utilizes retinal images to stratify CVD risk.

Authors

  • Chan Joo Lee
    Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.
  • Tyler Hyungtaek Rim
    Department of Ocular Epidemiology, Singapore Eye Research Institute, Singapore, Singapore.
  • Hyun Goo Kang
    Division of Retina, Severance Eye Hospital, Yonsei University College of Medicine, Seoul 03722, South Korea.
  • Joseph Keunhong Yi
    Department of Ophthalmology and Visual Science, University of Texas Health Science Center at Houston, Houston, TX 77030, USA.
  • Geunyoung Lee
    MediWhale, Seoul, South Korea.
  • Marco Yu
    Singapore Eye Research Institute, Singapore National Eye Centre, Singapore.
  • Soo-Hyun Park
    Food Functionality Research Division, Korea Food Research Institute, Wanju 55365, South Korea.
  • Jin-Taek Hwang
    Food Functionality Research Division, Korea Food Research Institute, Wanju 55365, South Korea.
  • Yih-Chung Tham
    Singapore Eye Research Institute, Singapore National Eye Centre, Singapore; Ophthalmology and Visual Sciences Academic Clinical Program (Eye ACP), Duke-NUS Medical School, Singapore.
  • Tien Yin Wong
    Singapore National Eye Center, Duke-National University of Singapore Medical School, Singapore 168751, Singapore; National Institutes of Health Research Biomedical Research Centre Biomedical Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
  • Ching-Yu Cheng
    Singapore National Eye Centre, Singapore Eye Research Institute, Singapore, Singapore.
  • Dong Wook Kim
    3 Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • Sung Soo Kim
    The Heart Center of Chonnam National University Hospital, 42 Jaebongro, Dong-gu, Gwangju 501-757, South Korea.
  • Sungha Park
    Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea; Integrated Research Center for Cerebrovascular and Cardiovascular Disease, Yonsei University College of Medicine, Seoul, South Korea.