Electrocardiogram, Valvular Heart DiseaseNCT06475157
Artificial Intelligence-enhanced Electrocardiogram Diagnoses and Predicts Future Regurgitant Valvular Heart Diseases
An observational study of Electrocardiogram, Valvular Heart Disease, run by Shanghai Zhongshan Hospital at 2 sites in 2 countries.
Trial summary
This is a retrospective study to establish models for the prediction of future valvular heart diseases with artificial intelligence-enhanced electrocardiogram (ECG). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electrocardiogram, Valvular Heart Disease
- How many people
- 500,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2024to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: An overall population.
Who may be able to join
- Subjects that received ECG and echocardiography tests during a date frame.
Who cannot join
- Subjects who is younger than 18 years of age.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Artificial Intelligence-enhanced Electrocardiogram Diagnoses and Predicts Future
This is a retrospective study to establish models for the prediction of future valvular heart diseases with artificial intelligence-enhanced electrocardiogram (ECG).
- Being tested
- No intervention
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention is applied.
| Study group | Role | What they receive |
|---|---|---|
| Patient group with progression of valvular heart diseases | Not described Receives: Other: No intervention | |
| Patient group without progression of valvular heart diseases | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Mar 2024
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrocardiogram, Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475157
- Sponsor's protocol ID
- AIECG_VHDP
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-enhanced Electrocardiogram Diagnoses and Predicts Future
- ClinicalTrials.gov ID
- NCT06475157
- Acronym / sponsor ID
- AIECG_VHDP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500,000 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective study to establish models for the prediction of future valvular heart diseases with artificial intelligence-enhanced electrocardiogram (ECG).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group with progression of valvular heart diseases | – | Other: No intervention |
| Patient group without progression of valvular heart diseases | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- An overall population.
Key inclusion criteria (1 listed)
- Subjects that received ECG and echocardiography tests during a date frame.
Key exclusion criteria (1 listed)
- Subjects who is younger than 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention is applied. | Other | Patient group with progression of valvular heart diseases, Patient group without progression of valvular heart diseases |
Primary outcome
Progression of valvular heart diseases
Time frame: 15 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrocardiogram, Valvular Heart Disease, run by Shanghai Zhongshan Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of valvular heart diseases (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.