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Prevalence of Rheumatic Heart Disease According to Revised Jones Criteria (2015) in Assiut Governate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316897
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : February 22, 2023
Sponsor:
Information provided by (Responsible Party):
Shady Hossam Nader Kamel, Assiut University

Study Description
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Brief Summary:
Prevalence of rheumatic heart disease according to revised jones criteria (2015) in Assiut governate

Condition or disease Intervention/treatment
Rheumatic Fever Device: Echocardiography

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Prevalence of Rheumatic Heart Disease According to Revised Jones Criteria (2015) in Assiut Governate
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : October 31, 2021
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: Baseline ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
This study will be conducted in February and October 2021. It will include 384 children attending in outpatient general clinics of Assiut University Children Hospital
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316897


Contacts
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Contact: Shady H. Kamel 01002798114 Shodnader@gmail.com
Contact: Amr M. Kotb 01009898678 amrkotb336@yahoo.com

Locations
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Egypt
Assiut University Recruiting
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Fahim M. Fahim Doctor
More Information
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Publications:

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Responsible Party: Shady Hossam Nader Kamel, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04316897    
Other Study ID Numbers: LAPRHFP
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rheumatic Heart Disease
Rheumatic Fever
Rheumatic Diseases
Heart Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
 Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Arthritis
Joint Diseases