NCT06152315

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

October 30, 2023

Last Update Submit

November 29, 2023

Conditions

Mitral Regurgitation

Keywords

echocardiographysplay signseagull cry

Outcome Measures

Primary Outcomes (2)

  • 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

  • Presence of narrow doppler bands

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

    1 year

Secondary Outcomes (1)

  • Mitral regurgitation severity

    1 year

Other Outcomes (4)

  • Blood pressure

    1 year

  • Age

    1 year

  • Gender

    1 year

  • +1 more other outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to echocardiography in community hospital in Tarusa

You may qualify if:

  • any patient undergoing echocardiography for clinical indications

You may not qualify if:

  • poor quality of recorded echocardiography study
  • inability to ascertain severity of mitral regurgitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarusa Hospital

Tarusa, Kaluga Oblast, 249100, Russia

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher in Digital Public Health Technologies

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 30, 2023

Study Start

January 1, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

All the data including anonymized echocardiography studies.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
along with the publication
Access Criteria
publicly accessible

Locations

RU(1)