Diagnostic Study of Structural Heart Disease Based on Cardiac Electromechanical Signals

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

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 \[add additional participating institutions as applicable\].

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

- 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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,300 Participants
are divided into 2 treatment groups
Group A: Valvular Lesions1 intervention
Group B: Case Group (Valvular Lesions)1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital Xi'an Jiaotong University

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: