Mitral RegurgitationNCT06152315
Mitral Splay Sign, Its Mechanism and Association With Severity of Regurgitation
An observational study of Mitral Regurgitation, run by ITMO University at 1 site in Russia.
Trial summary
To study echocardiography splay sign in mitral regurgitation and its association with mitral regurgitation severity and doppler band artifact ('seagull cry'). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to echocardiography in community hospital in Tarusa
Who may be able to join
- any patient undergoing echocardiography for clinical indications
Who cannot join
- poor quality of recorded echocardiography study
- inability to ascertain severity of mitral regurgitation
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Tarusa Hospital
Tarusa, Kaluga Oblast, 249100
Artemiy Okhotin, MD, +74843525754, dr.okhotin@gmail.com
About this study
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
To study echocardiography splay sign in mitral regurgitation and its association with mitral regurgitation severity and doppler band artifact ('seagull cry').
- Conditions
- Mitral Regurgitation
- Keywords
- echocardiography, splay sign, seagull cry
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Presence of narrow doppler bands
Logical, presence of narrow bands during continuous doppler echocardiography assessed by two echocardiographers (one blinded)
Measured: 1 year
Secondary outcomes (1)
Mitral regurgitation severity
Categorical, Grade of severity of mitral regurgitation assessed by echocardiography by two independent echocardiographers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jan 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ITMO University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artemiy Okhotin, ITMO University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152315
- Sponsor's protocol ID
- TARUSA SPLAY STUDY
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data including anonymized echocardiography studies.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06152315
- Acronym / sponsor ID
- TARUSA SPLAY STUDY
- Conditions
- Mitral Regurgitation
- Keywords
- echocardiography, splay sign, seagull cry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ITMO UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study echocardiography splay sign in mitral regurgitation and its association with mitral regurgitation severity and doppler band artifact ('seagull cry').
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to echocardiography in community hospital in Tarusa
Key inclusion criteria (1 listed)
- any patient undergoing echocardiography for clinical indications
Key exclusion criteria (2 listed)
- poor quality of recorded echocardiography study
- inability to ascertain severity of mitral regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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 secondary outcome
Mitral regurgitation severity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: Yes. All the data including anonymized echocardiography studies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by ITMO University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of mitral splay sign (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.