Rheumatic FeverNCT04316897
Prevalence of Rheumatic Heart Disease According to Revised Jones Criteria (2015) in Assiut Governate
An observational study of Rheumatic Fever, run by Assiut University at 1 site in Egypt.
Trial summary
Prevalence of rheumatic heart disease according to revised jones criteria (2015) in Assiut governate Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Rheumatic Fever
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Prevalence of rheumatic heart disease according to revised jones criteria (2015) in Assiut governate
Read the 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.
- Conditions
- Rheumatic Fever
- Being tested
- Echocardiography
- Medical subject headings
- Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 Feb 2021
- Primary completion31 Oct 2021
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic FeverStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Hossam Nader Kamel, Assiut University
- Investigators
- Fahim M. Fahim, Study director, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316897
- Sponsor's protocol ID
- LAPRHFP
- Status last verified
- Feb 2023
- First submitted
- 19 Mar 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25908771
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Rheumatic Heart Disease According to Revised Jones Criteria (2015) in Assiut Governate
- ClinicalTrials.gov ID
- NCT04316897
- Acronym / sponsor ID
- LAPRHFP
- Conditions
- Rheumatic Fever
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevalence of rheumatic heart disease according to revised jones criteria (2015) in Assiut governate
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyIt 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. | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Background: PubMed 25908771Gewitz 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.
Related trials for Rheumatic Fever
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
Not yet recruiting
Assessment of the Prevalence of Rheumatic Heart Disease in School Settings in Mayotte and the Acquisition of Ultrasound Sequences Guided by Artificial Intelligence
Rheumatic Heart Diseases, Scabies
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahim M. Fahim study director
Doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Fever, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shady H. Kamel (01002798114, Shodnader@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.