ECG and CXR for Predicting Cardiovascular Diseases

NCT07573852 | Completed

• 1 other identifier: B2024-497
• Study Type: observational
• Target: 116,380
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Heart Valve Diseases; Gastroesophageal Reflux; Aortic Valve Insufficiency; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Aortic Valve Disease

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: July 14, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-03

Locations

CN (1)