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NCT06152315 Clinical Trial

Mitral Splay Sign, Its Mechanism and Association With Severity of Regurgitation

Mitral Regurgitation Clinical Trial

Official title:
Study of Splay Sign in Mitral Regurgitation and Other Valve Lesions as Related to Its Mechanisms, Predictors of Its Occurence and Association With Severity of Mitral Regurgitation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06152315
Other study ID # TARUSA SPLAY STUDY
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 30, 2023

Study information
Verified date November 2023
Source ITMO University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To study echocardiography splay sign in mitral regurgitation and its association with mitral regurgitation severity and doppler band artifact ('seagull cry').

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - any patient undergoing echocardiography for clinical indications Exclusion Criteria: - poor quality of recorded echocardiography study - inability to ascertain severity of mitral regurgitation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Russian Federation Tarusa Hospital Tarusa Kaluga Region

Sponsors (1)
Lead Sponsor Collaborator
ITMO University

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Other Blood pressure Numerical, Arterial blood pressure measured during the study 1 year
Other Age Numerical, Age of the patient 1 year
Other Gender Categorical, Gender of the patient 1 year
Other BMI Numerical, Body mass index (weight divided by squared height) 1 year
Primary Presence of mitral splay sign Logical, Presence of splay sign -- wide linear color doppler artifact on the level of valve coaptation disproportional to the width of the regurgitant jet 1 year
Primary Presence of narrow doppler bands Logical, presence of narrow bands during continuous doppler echocardiography assessed by two echocardiographers (one blinded) 1 year
Secondary Mitral regurgitation severity Categorical, Grade of severity of mitral regurgitation assessed by echocardiography by two independent echocardiographers 1 year
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