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].

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Key information

Conditions

Valvular Heart Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transthoracic echocardiography

Diagnostic Test

All patients in the case group undergo transthoracic echocardiography to assess valvular structure and function, which is the core diagnostic intervention for valvular lesions.

Primary outcomes

Diagnostic Accuracy (Sensitivity and Specificity) of the Novel Assay for Valvular Heart Disease

Time frame: Baseline (At the time of initial diagnostic testing)

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Yi Xiao, MD

CONTACT

[email protected]

+86-029-85323816

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

Second Affiliated Hospital of Xi'an Jiaotong University

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: May 22, 2026
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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