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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04316897
Other study ID # LAPRHFP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date April 30, 2023

Study information

Verified date February 2023
Source Assiut University
Contact Shady H. Kamel
Phone 01002798114
Email Shodnader@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prevalence of rheumatic heart disease according to revised jones criteria (2015) in Assiut governate


Description:

Although acute rheumatic fever (ARF) has declined in Europe and North America in incidence over the past 4 to 6 decades, the disease remains one of the most important causes of cardiovascular morbidity and mortality especially in the developing countries that are home to the majority of the world's population(1), Incidence rates in these countries still reach epidemic levels(2). In general, most patients with RHD do not have documented histories of ARF, and they present with late complications, such as heart failure, arrhythmia, stroke, endocarditis, or pregnancy-related complications(3). Echocardiographic screening according to revised jones criteria (2015) (1) is the most reliable way of detecting RHD in asymptomatic people, and it can identify large numbers of previously undetected cases(4-6). People with RHD detected by screening can receive appropriate cardiac care, including guideline-recommended secondary prophylaxis(7). This may be a cost-effective approach to managing RHD in groups at high risk in Assiut Governate(8). Nevertheless, large scale screening has not been undertaken, and studies are underway to determine the best models for sustainable targeted screening and to evaluate the impact of screening and treatment on clinical outcomes(9). In this study, we aimed to determine the role of echocardiographic screening for detecting undiagnosed RHD, and to estimate the prevalence of RHD in Assiut Governate.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 30, 2023
Est. primary completion date October 31, 2021
Accepts healthy volunteers
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria: - Children and young adults aged 5-18 years living in Assiut Governate ,who are attending general clinics of Assiut University Children Hospital, were invited to participate in echocardiographic screening for RHD in February and October 2021. Informed consent will be obtained in writing from participants or their parents after providing explanations of the study in local languages.

Study Design


Intervention

Device:
Echocardiography
It is a an observational cross-sectional echocardiographic screening study in Assiut Governate conducted after seeking approval from the local institutional review board and human subjects' protection.

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Gewitz MH, Baltimore RS, Tani LY, Sable CA, Shulman ST, Carapetis J, Remenyi B, Taubert KA, Bolger AF, Beerman L, Mayosi BM, Beaton A, Pandian NG, Kaplan EL; American Heart Association Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young. Revision of the Jones Criteria for the diagnosis of acute rheumatic fever in the era of Doppler echocardiography: a scientific statement from the American Heart Association. Circulation. 2015 May 19;131(20):1806-18. doi: 10.1161/CIR.0000000000000205. Epub 2015 Apr 23. Erratum In: Circulation. 2020 Jul 28;142(4):e65. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The aim of the study is to assess the prevalence of rheumatic heart disease (RHD) according to the American Heart Association modified Jones criteria 2015 (1). Cases will be defined as definite, probable or not RHD. Prevalence of rheumatic heart disease according to revised jones criteria (2015) in Assiut governate Cases will be defined as definite, probable or not RHD. So, it will provide a great outcome for all the targeted patients. Baseline
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