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Diagnostic Study of Structural Heart Disease Based on Cardiac Electromechanical Signals

Diagnostic Study of Structural Heart Disease Based on Cardiac Electromechanical Signals

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07603115
Enrollment
1300
Registered
2026-05-22
Start date
2026-05-01
Completion date
2027-12-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular Heart Disease

Brief summary

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 \[add additional participating institutions as applicable\].

Interventions

DIAGNOSTIC_TESTTransthoracic 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.

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER
Second Affiliated Hospital of Xi'an Jiaotong University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy (Sensitivity and Specificity) of the Novel Assay for Valvular Heart DiseaseBaseline (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.

Contacts

CONTACTHui Yi Xiao, MD
sbw_514@163.cpom+86-029-85323816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026