Diagnostic Study of Structural Heart Disease Based on Cardiac Electromechanical Signals

N/ANot Yet RecruitingNCT07603115

First Affiliated Hospital Xi'an Jiaotong University1,300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,300

Conditions

Valvular Heart Disease

Interventions

Transthoracic EchocardiographyDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Central Contacts

Hui Yi Xiao, MD

CONTACT

+86-029-85323816 sbw_514@163.cpom

Data from ClinicalTrials.gov

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