Three Dimensional Versus Two Dimensional Echocardiography in Assessment of Severity and Scoring of Rheumatic Mitral Stenosis.

NCT ID: NCT04968431

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-31

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Valve Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mitral Stenosis patient

2D Echocardiography

Intervention Type OTHER

Mitral valve area will be determined by 2 D echo-Doppler methods

3D Echocardiography

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

2D Echocardiography

Mitral valve area will be determined by 2 D echo-Doppler methods

Intervention Type OTHER

3D Echocardiography

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patient age range from 18 years to 60 years.
2. Patient with isolated mitral stenosis (except those with mild mitral regurgitation and are candidate for PTMC by 2D Echo evaluation).
3. Patient with normal left ventricular EF
4. patient both in sinus rhythm or atrial fibrillation

Exclusion Criteria

1. Age below 18 years or above 60 years.
2. Patient with another valve lesion or more than mild mitral regurgitation.
3. Patient with impaired cardiac function.
4. Mitral stenosis of other etiology than rheumatic origin
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ibrahim Sayed

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16253886 (View on PubMed)

Baumgartner 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.

Reference Type BACKGROUND
PMID: 28886619 (View on PubMed)

Lang 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.

Reference Type BACKGROUND
PMID: 22275509 (View on PubMed)

Wunderlich 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.

Reference Type BACKGROUND
PMID: 24229772 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

rheumatic mitral stenosis

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.