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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

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