NCT06924580

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Jan 2017Dec 2026

Study Start

First participant enrolled

January 18, 2017

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 11, 2025

Status Verified

December 1, 2024

Enrollment Period

10 years

First QC Date

April 6, 2025

Last Update Submit

April 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Multi-system disease predicting based on ECG

    Evaluating the effectiveness of ECG in predicting diseases across various systems, such as circulatory system diseases, respiratory system diseases, digestive system diseases, nervous system diseases, urogenital system diseases, endocrine and nutritional/metabolic system diseases, hematological diseases, infectious and parasitic diseases, tumors, and mental and behavioral disorders. This study initially uses the ICD-10 coding system for preliminary screening of target diseases. Subsequently, a committee of multidisciplinary clinical experts conducts a systematic review of candidate diseases based on the ICD-10 coding system framework, including the applicability of diagnostic criteria, the accuracy of ICD-10 classification, the reasonableness of exclusion criteria, and the assessment of the level of evidence.

    1 month

Interventions

Each subject is subjected to ECG assessment.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing ECG examinations

You may qualify if:

  • Patients who visited the study hospital.
  • Patients included should have both ECG data and discharge diagnosis codes (ICD-10) for inpatients and emergency patients.

You may not qualify if:

  • \. Patients who declined participation, cases with incomplete or missing clinical data, and pregnant individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2025

First Posted

April 11, 2025

Study Start

January 18, 2017

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 11, 2025

Record last verified: 2024-12

Locations