Diagnostic Study of Structural Heart Disease Based on Cardiac Electromechanical Signals

Study participants will be prospectively recruited from consecutive outpatient and inpatient populations presenting to the Cardiology and Cardiac Surgery Departments of the following participating institutions: The First Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Xi'an Jiaotong University, and [add additional participating institutions as applicable].

Study Overview

• Status: Not yet recruiting
• Conditions: Valvular Heart Disease
• Intervention / Treatment: Diagnostic test: Transthoracic Echocardiography

• Study Type: Observational
• Enrollment (Estimated): 1300

Contacts and Locations

• Study Contact: Name: Hui Yi Xiao, MD; Phone Number: +86-029-85323816; Email: sbw_514@163.cpom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study sample will be recruited from outpatient and inpatient populations in the cardiology and cardiac surgery departments of multiple participating centers, covering patients with valvular heart disease of various types and severity levels, as well as healthy individuals or those undergoing routine health check-ups as controls. Specifically, the case group consists of patients aged ≥ 18 years with valvular lesions confirmed by transthoracic echocardiography and who can complete speckle tracking echocardiography, while the control group includes individuals with normal cardiac valves and no other cardiovascular diseases confirmed by echocardiography.

Description

Inclusion Criteria:

• - Aged ≥ 18 years.
• For the case group: Presence of valvular lesions confirmed by transthoracic echocardiography.
• For the control group: Normal cardiac valves and no evidence of other cardiovascular diseases confirmed by transthoracic echocardiography.
• Ability to undergo and complete speckle tracking echocardiography.

Exclusion Criteria:

• Patients who are unwilling to participate in this study.
• Patients with a known allergy to the electrode patches or medical adhesive tapes used in this study.
• Patients who are unable to cooperate with the completion of required examinations.
• Patients with incomplete clinical or imaging data that cannot be supplemented.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Valvular Lesions; Case Group	Diagnostic test: Transthoracic Echocardiography; All patients in the case group undergo transthoracic echocardiography to assess valvular structure and function, which is the core diagnostic intervention for valvular lesions.
Case Group (Valvular Lesions); This group consists of 960 cases covering 24 valvular lesion subtypes (40 cases per subtype), designed for exploratory comparative analysis of each subtype.	Diagnostic test: Transthoracic Echocardiography; All patients in the case group undergo transthoracic echocardiography to assess valvular structure and function, which is the core diagnostic intervention for valvular lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy (Sensitivity and Specificity) of the Novel Assay for Valvular Heart Disease	Demonstrates the diagnostic detection performance of the novel assay in identifying patients with valvular heart disease, measured by sensitivity and specificity against the reference standard .This outcome reflects the assay's ability to detect valvular lesions across 24 distinct subtypes.	Baseline (At the time of initial diagnostic testing)

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: ABC202511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No