NCT04316897

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

March 19, 2020

Last Update Submit

February 20, 2023

Conditions

Outcome Measures

Primary Outcomes (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.

    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

Interventions

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.

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

Related 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.

    PMID: 25908771BACKGROUND

MeSH Terms

Conditions

Rheumatic Fever

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Fahim M. Fahim

    Doctor

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 20, 2020

Study Start

February 1, 2021

Primary Completion

October 31, 2021

Study Completion

April 30, 2023

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations