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

Mitral Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04968431
• Other study ID #: rheumatic mitral stenosis
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: July 2024

Study information

• Verified date: July 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Mitral Valve Stenosis

Intervention

Other:
• 2D Echocardiography
Mitral valve area will be determined by 2 D echo-Doppler methods
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Muñoz D, Rosenhek R, Sjögren 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	benefit of 3D echocardiography in mitral stenosis scoring	The added benefit of 3D echocardiography over 2D echo in evaluation of rheumatic mitral stenosis score	1 year