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

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 Overview

• Status: Not yet recruiting
• Conditions: Mitral Valve Stenosis
• Intervention / Treatment: Other: 2D Echocardiography; Other: 3D Echocardiography

• Study Type: Observational
• Enrollment (Anticipated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

will be taken as a total coverage over a period of 1 year from patients attending Assiut University Heart Hospital outpatient clinic.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mitral Stenosis patient	Other: 2D Echocardiography; Mitral valve area will be determined by 2 D echo-Doppler methods; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (ACTUAL): July 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Constriction, Pathologic; Mitral Valve Stenosis
• Other Study ID Numbers: rheumatic mitral stenosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No