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ECG and CXR for Predicting Cardiovascular Diseases

A Retrospective Cohort Study of Multimodal Electrocardiography and Chest Radiography for Prediction of Progression to Moderate or Severe Regurgitant Valvular Heart Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07573852
Enrollment
116380
Registered
2026-05-07
Start date
2017-07-14
Completion date
2025-12-31
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regurgitation, Aortic Valve, Regurgitation, Mitral, Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation

Brief 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. 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.

Interventions

None listed

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Incident Regurgitant Valvular Heart DiseaseUp to 5 yearsIncident 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026