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

Sponsor
ITMO University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06152315
Collaborator
(none)
80
Enrollment
1
Location
11.9
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Dec 30, 2023
    Anticipated Study Completion Date :
    Dec 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    mitral splay sign

    Patients with at least mild mitral regurgitation and splay sign on color doppler echocardiography
    no mitral splay sign

    Patients with at least mild mitral regurgitation and no splay sign on color doppler echocardiography

    Outcome Measures

    Primary Outcome Measures

    1. Presence of mitral splay sign [1 year]

      Logical, Presence of splay sign -- wide linear color doppler artifact on the level of valve coaptation disproportional to the width of the regurgitant jet

    2. Presence of narrow doppler bands [1 year]

      Logical, presence of narrow bands during continuous doppler echocardiography assessed by two echocardiographers (one blinded)

    Secondary Outcome Measures

    1. Mitral regurgitation severity [1 year]

      Categorical, Grade of severity of mitral regurgitation assessed by echocardiography by two independent echocardiographers

    Other Outcome Measures

    1. Blood pressure [1 year]

      Numerical, Arterial blood pressure measured during the study

    2. Age [1 year]

      Numerical, Age of the patient

    3. Gender [1 year]

      Categorical, Gender of the patient

    4. BMI [1 year]

      Numerical, Body mass index (weight divided by squared height)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • any patient undergoing echocardiography for clinical indications
    Exclusion Criteria:

    • poor quality of recorded echocardiography study

    • inability to ascertain severity of mitral regurgitation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tarusa Hospital Tarusa Kaluga Region Russian Federation 249100

    Sponsors and Collaborators

    • ITMO University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Artemiy Okhotin, researcher in Digital Public Health Technologies, ITMO University
    ClinicalTrials.gov Identifier:
    NCT06152315
    Other Study ID Numbers:
    • TARUSA SPLAY STUDY
    First Posted:
    Nov 30, 2023
    Last Update Posted:
    Nov 30, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Artemiy Okhotin, researcher in Digital Public Health Technologies, ITMO University
    echocardiography
    splay sign
    seagull cry
    Additional relevant MeSH terms:
    Mitral Valve Insufficiency

    Study Results

    No Results Posted as of Nov 30, 2023