Valvular Heart DiseasesNCT07573852
ECG and CXR for Predicting Cardiovascular Diseases
An observational study of Valvular Heart Diseases and Valvular Heart Disease Stenosis and Regurgitation, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This retrospective multicenter cohort study aims to develop and validate an artificial intelligence model integrating electrocardiography (ECG) and chest radiography (CXR) to predict future progression of regurgitant valvular heart disease (rVHD), including aortic, mitral, and tricuspid regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation, Regurgitation, Aortic Valve
- How many people
- 116,380 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2017to 31 Dec 2025
- 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: This study population was a retrospective multicenter, echo-phenotyped longitudinal cohort derived from routine clinical care. The development cohort was obtained from Zhongshan Hospital, Shanghai, China, and included consecutive adult patients receiving care between July 14, 2017 and December 31, 2023. An external validation cohort was obtained from a second center using the same eligibility framework. The cohort was anchored to routinely acquired ECG and CXR, with baseline echocardiography used to define prevalent valvular status and follow-up echocardiography used to determine progression to clinically significant regurgitant valvular heart disease.
Who may be able to join
- Adult patients aged ≥18 years. Underwent routine electrocardiography (ECG), chest radiography (CXR), and echocardiography within 60 days.
- Had subsequent follow-up echocardiographic data available for outcome ascertainment.
- Patients were identified from routine clinical practice in inpatient admission or outpatient evaluation settings.
Who cannot join
- Age below the adult threshold. Missing any of the required baseline examinations (ECG, CXR, or echocardiography within 60 days).
- No follow-up echocardiographic data available. For future-risk evaluation in the test cohort, samples with moderate or severe regurgitation at baseline were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Cohort Study of Multimodal Electrocardiography and Chest Radiography for Prediction of Progression to Moderate or Severe Regurgitant Valvular Heart Disease
This retrospective multicenter cohort study aims to develop and validate an artificial intelligence model integrating electrocardiography (ECG) and chest radiography (CXR) to predict future progression of regurgitant valvular heart disease (rVHD), including aortic, mitral, and tricuspid regurgitation. Adult patients with ECG, CXR, and echocardiography obtained within 60 days, together with follow-up echocardiographic data, are included. The primary objective is to determine whether multimodal ECG+CXR modeling improves prediction of progression to moderate or severe regurgitation beyond ECG-only or CXR-only models. Secondary objectives include evaluation of clinical utility, risk stratification, and model interpretability. This study is intended to assess whether routinely acquired ECG and CXR can be used to support surveillance echocardiography and risk-directed management in patients at risk of future rVHD progression.
- Conditions
- Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation, Regurgitation, Aortic Valve, Regurgitation, Mitral
- Medical subject headings
- Heart Valve Diseases, Gastroesophageal Reflux, Aortic Valve Insufficiency, Mitral Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Regurgitant Valvular Heart Disease
Incident regurgitant valvular heart disease was defined as new progression to moderate or severe aortic regurgitation, mitral regurgitation, or tricuspid regurgitation on follow-up echocardiography after the index ECG-CXR assessment. For each target valve, patients with no or mild regurgitation at baseline were considered at risk, and the first follow-up echocardiographic examination showing moderate or severe regurgitation was considered an incident event.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start14 Jul 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseasesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 116,380 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
- NCT07573852
- Sponsor's protocol ID
- B2024-497
- Status last verified
- Mar 2026
- First submitted
- 1 May 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study of Multimodal Electrocardiography and Chest Radiography for Prediction of Progression to Moderate or Severe Regurgitant Valvular Heart Disease
- ClinicalTrials.gov ID
- NCT07573852
- Acronym / sponsor ID
- B2024-497
- Conditions
- Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation, Regurgitation, Aortic Valve, Regurgitation, Mitral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116,380 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 May 2026 (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 retrospective multicenter cohort study aims to develop and validate an artificial intelligence model integrating electrocardiography (ECG) and chest radiography (CXR) to predict future progression of regurgitant valvular heart disease (rVHD), including aortic, mitral, and tricuspid regurgitation. Adult patients with ECG, CXR, and echocardiography obtained within 60 days, together with follow-up echocardiographic data, are included. The primary objective is to determine whether multimodal ECG+CXR modeling improves prediction of progression to moderate or severe regurgitation beyond ECG-only or CXR-only models. Secondary objectives include evaluation of clinical utility, risk stratification, and model interpretability. This study is intended to assess whether routinely acquired ECG and CXR can be used to support surveillance echocardiography and risk-directed management in patients at risk of future rVHD progression.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study population was a retrospective multicenter, echo-phenotyped longitudinal cohort derived from routine clinical care. The development cohort was obtained from Zhongshan Hospital, Shanghai, China, and included consecutive adult patients receiving care between July 14, 2017 and December 31, 2023. An external validation cohort was obtained from a second center using the same eligibility framework. The cohort was anchored to routinely acquired ECG and CXR, with baseline echocardiography used to define prevalent valvular status and follow-up echocardiography used to determine progression to clinically significant regurgitant valvular heart disease.
Key inclusion criteria (3 listed)
- Adult patients aged ≥18 years. Underwent routine electrocardiography (ECG), chest radiography (CXR), and echocardiography within 60 days.
- Had subsequent follow-up echocardiographic data available for outcome ascertainment.
- Patients were identified from routine clinical practice in inpatient admission or outpatient evaluation settings.
Key exclusion criteria (2 listed)
- Age below the adult threshold. Missing any of the required baseline examinations (ECG, CXR, or echocardiography within 60 days).
- No follow-up echocardiographic data available. For future-risk evaluation in the test cohort, samples with moderate or severe regurgitation at baseline were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident Regurgitant Valvular Heart Disease
Time frame: Up to 5 years
Incident regurgitant valvular heart disease was defined as new progression to moderate or severe aortic regurgitation, mitral regurgitation, or tricuspid regurgitation on follow-up echocardiography after the index ECG-CXR assessment. For each target valve, patients with no or mild regurgitation at baseline were considered at risk, and the first follow-up echocardiographic examination showing moderate or severe regurgitation was considered an incident event.
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 7 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Diseases and Valvular Heart Disease Stenosis and Regurgitation, run by Shanghai Zhongshan Hospital at 1 site in China.
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 3 inclusion and 2 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Incident Regurgitant Valvular Heart Disease (time frame: Up to 5 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 7 May 2026.