Clinical trial NCT06179849: Artificial Intelligence-enabled Large-scale Electrocardiogram Feature Extraction and Exploring Association Between the Extracted Features and Mortality, Stroke or Various Health Outcome of Interest
Official title: Artificial Intelligence-enabled Large-scale Electrocardiogram Feature Extraction and Exploring Association Between the Extracted Features and Mortality, Stroke or Various Health Outcome of Interest
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Health Status(Death, Stroke Etc)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 3000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients stored in the MUSE system after measuring a standard 12-guided electrocardiogram at Severance Health Checkup at Severance Hospital from November 1, 2005 to October 31, 2022

Brief summary: * In this study, large-scale ECG data (Electrocardiogram data of all patients stored in the MUSE system by measuring standard 12-guided ECG at Severance Health Checkup at Severance Hospital from November 1, 2005 to October 31, 2022) are combined with electronic medical records, National Health Insurance Corporation data, and National Statistical Office death cause data, and the artificial intelligence algorithm is used to extract ECG features to analyze the association between death, stroke, and various health conditions, and to conduct external verification or transfer learning using public databases (e.g., UK Biobank data).
* Intended to use a web-based artificial intelligence platform to distribute computational loads generated during large-scale data processing and improve analysis accuracy and efficiency.

Detailed description: * All patient IDs obtained from the main office are replaced by research IDs (de-identified IDs), so the actual ID is not exposed and other personal identification information (name, resident registration number) is not collected.
* Research Methods:

  1. Electrocardiogram extraction based on the criteria of subjects.
  2. Combined with extracted ECG data and National Insurance Corporation data (+ National Statistical Office cause of death data).
  3. Health out of interest (HOI) definition. Includes death, stroke, etc.
  4. The defined HOI can be extracted from Yonsei Medical Center data or from National Insurance Service data or Statistics Korea's cause of death data.
  5. Artificial intelligence model training with electrocardiogram (and clinical information diagram if necessary) as input, utilizing supervised deep learning algorithms if there is a label and unsupervised learning algorithms if there is no label.
  6. Performance evaluation for supervised learning artificial intelligence models.
  7. In the case of unsupervised learning artificial intelligence models, the association/correlation between extracted features and HOI or predictability/detectability analysis.
  8. Transfer learning can be performed by adding external verification or dielectric data to the learned model using public databases.
  9. External verification can be performed using external additional data by mounting the learned model on a web-based artificial intelligence platform.
  10. Considering large-scale data, computing workloads can be distributed using web-based artificial intelligence platforms.
  11. The analysis results can be anonymized and the analysis results can be provided to researchers through a web-based artificial intelligence platform.

Eligibility criteria: Inclusion Criteria:

All patients stored in the MUSE system after measuring a standard 12-guided electrocardiogram at Severance Health Checkup at Severance Hospital from November 1, 2005 to October 31, 2022

Primary outcomes:
measure: Number of patients with Mortality
timeFrame: 2 years
measure: Number of patients with Stroke, Atrial Fibrillation, Dementia
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
Study officials:
affiliation: Yonsei University
name: Hui-Nam Pak
role: PRINCIPAL_INVESTIGATOR
References: