Mitral Valve StenosisNCT04968431
Three Dimensional Versus Two Dimensional Echocardiography in Assessment of Severity and Scoring of Rheumatic Mitral Stenosis.
An observational study of Mitral Valve Stenosis, run by Assiut University.
Trial summary
Although the prevalence of rheumatic fever is decreasing in developed countries, it still affects numerous areas in the non- industrialized world. Untreated mitral stenosis (MS) contributes significantly to global morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mitral Valve Stenosis
- What is being tested?
- 2D Echocardiography and 3D Echocardiography
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Jul 2024
- 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 to 60 years
- All sexes
- Adult
Study population: will be taken as a total coverage over a period of 1 year from patients attending Assiut University Heart Hospital outpatient clinic.
Who may be able to join
- Patient age range from 18 years to 60 years.
- Patient with isolated mitral stenosis (except those with mild mitral regurgitation and are candidate for PTMC by 2D Echo evaluation).
- Patient with normal left ventricular EF
- patient both in sinus rhythm or atrial fibrillation
Who cannot join
- Age below 18 years or above 60 years.
- Patient with another valve lesion or more than mild mitral regurgitation.
- Patient with impaired cardiac function.
- Mitral stenosis of other etiology than rheumatic origin
About this study
Although the prevalence of rheumatic fever is decreasing in developed countries, it still affects numerous areas in the non- industrialized world. Untreated mitral stenosis (MS) contributes significantly to global morbidity and mortality. Echocardiography is the main diagnostic imaging modality for evaluation of mitral valve (MV) obstruction and assessment of severity and hemodynamic consequences of MS as well as valve morphology. According to current guidelines and recommendations for clinical practice, the severity of MS should not be defined by a single value but assessed by valve areas, mean Doppler gradients, and pulmonary pressures. Transthoracic echocardiography is usually sufficient to grade MS severity and to define the morphology of the valve. Transesophageal echocardiography is used when the valve cannot be adequately assessed with transthoracic echocardiography and to exclude intracardiac thrombi before a percutaneous or surgical intervention. Three-dimensional transthoracic and transesophageal echocardiographic assessment provide more detailed physiological and morphological information. Current definitive treatment for severe MS involves percutaneous balloon mitral valvuloplasty (PMBV) or surgery. The effectiveness of PMBV is related to the etiology of MS, and certain anatomic characteristics tend to predict a more successful outcome for PMBV, whereas other MV structural findings might suggest balloon valvuloplasty to be less likely successful or even contraindicated. Does 3D echo can add more useful information over 2 D echo that could change treatment decision?
- Conditions
- Mitral Valve Stenosis
- Being tested
- 2D Echocardiography, 3D Echocardiography
- Medical subject headings
- Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D EchocardiographyOther
Mitral valve area will be determined by 2 D echo-Doppler methods
3D EchocardiographyOther
Patients included in the study will undergo 3D Echo after being evaluated with 2D Echo. Mitral valve area will be determined by real time 3D.
| Study group | Role | What they receive |
|---|---|---|
| Mitral Stenosis patient | Not described Receives: Other: 2D Echocardiography; Other: 3D Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
benefit of 3D echocardiography in mitral stenosis severity
The added benefit of 3D echocardiography over 2D echo in evaluation of rheumatic mitral stenosis severity with pressure gradient
Measured: 1 year
benefit of 3D echocardiography in mitral stenosis scoring
The added benefit of 3D echocardiography over 2D echo in evaluation of rheumatic mitral stenosis score
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 posted20 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve StenosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968431
- Sponsor's protocol ID
- rheumatic mitral stenosis
- Status last verified
- Jul 2021
- First submitted
- 16 Jun 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005 Nov;5(11):685-94. doi: 10.1016/S1473-3099(05)70267-X.
PubMed 16253886Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.
PubMed 28886619Lang RM, Badano LP, Tsang W, Adams DH, Agricola E, Buck T, Faletra FF, Franke A, Hung J, de Isla LP, Kamp O, Kasprzak JD, Lancellotti P, Marwick TH, McCulloch ML, Monaghan MJ, Nihoyannopoulos P, Pandian NG, Pellikka PA, Pepi M, Roberson DA, Shernan SK, Shirali GS, Sugeng L, Ten Cate FJ, Vannan MA, Zamorano JL, Zoghbi WA; American Society of Echocardiography; European Association of Echocardiography. EAE/ASE recommendations for image acquisition and display using three-dimensional echocardiography. Eur Heart J Cardiovasc Imaging. 2012 Jan;13(1):1-46. doi: 10.1093/ehjci/jer316. No abstract available.
PubMed 22275509Wunderlich NC, Beigel R, Siegel RJ. Management of mitral stenosis using 2D and 3D echo-Doppler imaging. JACC Cardiovasc Imaging. 2013 Nov;6(11):1191-205. doi: 10.1016/j.jcmg.2013.07.008.
PubMed 24229772
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Versus Two Dimensional Echocardiography in Assessment of Severity and Scoring of Rheumatic Mitral Stenosis.
- ClinicalTrials.gov ID
- NCT04968431
- Acronym / sponsor ID
- rheumatic mitral stenosis
- Conditions
- Mitral Valve Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 20 Jul 2021 (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.
Although the prevalence of rheumatic fever is decreasing in developed countries, it still affects numerous areas in the non- industrialized world. Untreated mitral stenosis (MS) contributes significantly to global morbidity and mortality. Echocardiography is the main diagnostic imaging modality for evaluation of mitral valve (MV) obstruction and assessment of severity and hemodynamic consequences of MS as well as valve morphology. According to current guidelines and recommendations for clinical practice, the severity of MS should not be defined by a single value but assessed by valve areas, mean Doppler gradients, and pulmonary pressures. Transthoracic echocardiography is usually sufficient to grade MS severity and to define the morphology of the valve. Transesophageal echocardiography is used when the valve cannot be adequately assessed with transthoracic echocardiography and to exclude intracardiac thrombi before a percutaneous or surgical intervention. Three-dimensional transthoracic and transesophageal echocardiographic assessment provide more detailed physiological and morphological information. Current definitive treatment for severe MS involves percutaneous balloon mitral valvuloplasty (PMBV) or surgery. The effectiveness of PMBV is related to the etiology of MS, and certain anatomic characteristics tend to predict a more successful outcome for PMBV, whereas other MV structural findings might suggest balloon valvuloplasty to be less likely successful or even contraindicated. Does 3D echo can add more useful information over 2 D echo that could change treatment decision?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitral Stenosis patient | – | Other: 2D Echocardiography, Other: 3D Echocardiography |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- will be taken as a total coverage over a period of 1 year from patients attending Assiut University Heart Hospital outpatient clinic.
Key inclusion criteria (4 listed)
- Patient age range from 18 years to 60 years.
- Patient with isolated mitral stenosis (except those with mild mitral regurgitation and are candidate for PTMC by 2D Echo evaluation).
- Patient with normal left ventricular EF
- patient both in sinus rhythm or atrial fibrillation
Key exclusion criteria (4 listed)
- Age below 18 years or above 60 years.
- Patient with another valve lesion or more than mild mitral regurgitation.
- Patient with impaired cardiac function.
- Mitral stenosis of other etiology than rheumatic origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D EchocardiographyMitral valve area will be determined by 2 D echo-Doppler methods | Other | Mitral Stenosis patient |
| 3D EchocardiographyPatients included in the study will undergo 3D Echo after being evaluated with 2D Echo. Mitral valve area will be determined by real time 3D. | Other | Mitral Stenosis patient |
Primary outcome
benefit of 3D echocardiography in mitral stenosis severity
Time frame: 1 year
The added benefit of 3D echocardiography over 2D echo in evaluation of rheumatic mitral stenosis severity with pressure gradient
benefit of 3D echocardiography in mitral stenosis scoring
Time frame: 1 year
The added benefit of 3D echocardiography over 2D echo in evaluation of rheumatic mitral stenosis score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Background: PubMed 16253886Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005 Nov;5(11):685-94. doi: 10.1016/S1473-3099(05)70267-X.
- Background: PubMed 28886619Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.
- Background: PubMed 22275509Lang RM, Badano LP, Tsang W, Adams DH, Agricola E, Buck T, Faletra FF, Franke A, Hung J, de Isla LP, Kamp O, Kasprzak JD, Lancellotti P, Marwick TH, McCulloch ML, Monaghan MJ, Nihoyannopoulos P, Pandian NG, Pellikka PA, Pepi M, Roberson DA, Shernan SK, Shirali GS, Sugeng L, Ten Cate FJ, Vannan MA, Zamorano JL, Zoghbi WA; American Society of Echocardiography; European Association of Echocardiography. EAE/ASE recommendations for image acquisition and display using three-dimensional echocardiography. Eur Heart J Cardiovasc Imaging. 2012 Jan;13(1):1-46. doi: 10.1093/ehjci/jer316. No abstract available.
- Background: PubMed 24229772Wunderlich NC, Beigel R, Siegel RJ. Management of mitral stenosis using 2D and 3D echo-Doppler imaging. JACC Cardiovasc Imaging. 2013 Nov;6(11):1191-205. doi: 10.1016/j.jcmg.2013.07.008.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Stenosis, run by Assiut University.
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 4 inclusion and 4 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 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
benefit of 3D echocardiography in mitral stenosis severity (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?
On the ClinicalTrials.gov record for NCT04968431, which also lists 4 linked publications.
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 20 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.