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

November 29, 2023 updated by: Artemiy Okhotin, ITMO University

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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Kaluga Region
      • Tarusa, Kaluga Region, Russian Federation, 249100
        • Recruiting
        • Tarusa Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients referred to echocardiography in community hospital in Tarusa

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of mitral splay sign
Time Frame: 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
1 year
Presence of narrow doppler bands
Time Frame: 1 year
Logical, presence of narrow bands during continuous doppler echocardiography assessed by two echocardiographers (one blinded)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitral regurgitation severity
Time Frame: 1 year
Categorical, Grade of severity of mitral regurgitation assessed by echocardiography by two independent echocardiographers
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 1 year
Numerical, Arterial blood pressure measured during the study
1 year
Age
Time Frame: 1 year
Numerical, Age of the patient
1 year
Gender
Time Frame: 1 year
Categorical, Gender of the patient
1 year
BMI
Time Frame: 1 year
Numerical, Body mass index (weight divided by squared height)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ITMO University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARUSA SPLAY STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the data including anonymized echocardiography studies.

IPD Sharing Time Frame

along with the publication

IPD Sharing Access Criteria

publicly accessible

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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