NCT06924580

Early ECG Prediction of Multi-system Disease Cohort Establishment and Follow Up

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500,000 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This registered multicenter study aims to investigate the diagnostic efficacy of artificial intelligence-enhanced electrocardiography (AI-ECG) in detecting multi-system diseases. The research will utilize prospectively collected data from inpatient, emergency, and outpatient populations to develop ECG-based diagnostic, screening, and predictive models for multi-system diseases.

Detailed description

Recent advances in artificial intelligence (AI) have expanded the diagnostic capabilities of electrocardiography (ECG) beyond cardiovascular diseases. Emerging evidence demonstrates that AI-enhanced ECG analysis can provide valuable insights into age, gender, mortality risk, cardiac function, and systemic conditions such as electrolyte imbalances, renal dysfunction, and thyroid disorders. These findings position ECG as a promising tool for the identification and prediction of a broad spectrum of diseases. To further investigate the underlying mechanisms linking ECG abnormalities with multi-system diseases and to develop ECG-based diagnostic, screening, and predictive models, we initiated a multi-center, prospective, observational registry study involving patients undergoing ECG examinations. The goals of the project are as follows: 1\. AI-ECG Foundation Model Development 1. Diagnosis of traditional cardiovascular diseases (e.g., arrhythmias, myocardial infarction). 2. Screening of multi-system disorders, including: Circulatory, digestive, respiratory, and nervous system diseases, Endocrine/metabolic disorders, urogenital diseases, hematologic conditions, Neoplasms and mental health disorders. 3. Prediction of new-onset conditions (e.g., atrial fibrillation, heart failure, valvular diseases, NSTEMI, ventricular tachycardia) and 1-year mortality risk. 2\. Clinical Utility \& Implementation Leveraging the portability, cost-effectiveness, and non-invasiveness of ECG, our AI foundation model enables: 1. Rapid, large-scale screening in outpatient, inpatient, emergency, and community settings. 2. Early detection of multi-system diseases, guiding targeted diagnostic workups. 3\. Mechanistic \& Interpretability Research Elucidating the diagnostic, predictive, and risk-stratification logic of AI-ECG foundation models.

Conditions

• Public Health
• Public Health System Research
• Multi-system Disease Diagnosis

Interventions

Type	Name	Description
OTHER	ECG screening	Each subject is subjected to ECG assessment.

Timeline

• Start date: 2017-01-18
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2025-04-11
• Last updated: 2025-04-11

Locations

1 site across 1 country: China