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CompletedNCT06475157Updated Jul 5, 2024

Artificial Intelligence-enhanced Electrocardiogram Diagnoses and Predicts Future Regurgitant Valvular Heart Diseases

An observational study in Electrocardiogram, Valvular Heart Disease, sponsored by Shanghai Zhongshan Hospital. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Shanghai Zhongshan Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
500,000
Ages
18 Years and older
Sex
All
01

Study summary

This is a retrospective study to establish models for the prediction of future valvular heart diseases with artificial intelligence-enhanced electrocardiogram (ECG).

02

Conditions studied

  • Electrocardiogram, Valvular Heart Disease
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 500,000 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 638 studies on the registry; 285 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

An overall population.

Inclusion criteria

  • Subjects that received ECG and echocardiography tests during a date frame.

Exclusion criteria

Exclusion Criteria:

  • Subjects who is younger than 18 years of age.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
500,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Patient group with progression of valvular heart diseases

    Other: No intervention

  • Patient group without progression of valvular heart diseases

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention is applied.

06

What researchers measure

Primary outcomes

  1. Progression of valvular heart diseases

    There would be echo records of subjectes of the study during follow-up. So for subjects with baseline none or mild valvular heart diseases, including mitral regurgitation, aortic regurgitation, and tricuspid regurgitation, there might be some with progression to moderate or severe valvular heart diseases, and some other without this progression. The primary outcome of the study would be the progression of valvular heart diseases from none or mild to moderateor severe, as assessed by echocardiography.

    Time frame: 15 years

07

Study locations

2 sites
  • 180 Fenglin Road
    Shanghai, 200032, China
  • Hammersmiths Hospital
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06475157
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Mar 1, 2024
Primary completion
May 30, 2024
Completion
May 30, 2024
Last update
Jul 5, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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