FMFNCT06047938
FMF and Atheroscelerosis
An observational study of FMF, run by Assiut University.
Trial summary
The aim of this study is to search for subclinical atherosclerosis in children diagnosed as FMF in Assiut University children's Hospital, and to correlate the risk to develop atherosclerosis to the different characters and genetic variants of FMF. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- FMF
- What is being tested?
- ultrasound on carotid
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to Dec 2024
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All patients that present with FMF in Assiut University Pediatric Hospital (allergy , immunology and rheumatology department)in one year.
Who may be able to join
- Age at enrollment less than18 years.
- Both sexes.
- Diagnosed as familial Mediterranean fever according to Tel Hashomer criteria. [10]
Who cannot join
- Patients with acute or chronic active infections.
- Patients with pre-existing illness as chronic lung, liver or renal diseases.
- Patients with diabetes mellitus, atherosclerotic vascular disease.
- Patients with malignancy
Trial locations and contacts
No sites are listed yet.
Naglaa mohamed samy, lecturer contact
About this study
Official title: Familial Mediteranean Fever in Upper Egypt, and Its Relation to Atherosclerosis in Children
The aim of this study is to search for subclinical atherosclerosis in children diagnosed as FMF in Assiut University children's Hospital, and to correlate the risk to develop atherosclerosis to the different characters and genetic variants of FMF.
Read the detailed description
- To describe the clinical characteristics of patients diagnosed as FMF in Upper Egypt, and to find the most common presenting symptoms.
- To mention the most common genetic variants reported in FMF patients in Upper Egypt, and to correlate the genetic variant with the risk to develop atherosclerosis.
- To assess the growth parameters in patients with FMF and compare it with the control group.
- To estimate the differences in Complete blood count (CBC) parameters, lipid profile, CIT in patients with FMF and control group.
- To search for subclinical atherosclerosis in patients with FMF based on their lipid profile and CIT.
- Conditions
- FMF
- Being tested
- ultrasound on carotid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound on carotidRadiation
CIT will be assessed using ultrasound evaluation by measuring the intima-media thickness of carotid arteries (IMT). This non-invasive method is used to detect subclinical atherosclerosis and it can be used in a multitude of patients including children[11]. It will be carried out on the two study groups (FMF patients and the control group) and the results will be compared. It will be conducted in Assiut University Neurosonology Unit, at the Department of Neurology.
| Study group | Role | What they receive |
|---|---|---|
| carotid intima thickness measurment | CIT will be assessed using ultrasound evaluation by measuring the intima-media thickness of carotid arteries (IMT). This non-invasive method is used to detect subclinical atherosclerosis and it can be used in a multitude of patients including children. It will be carried out on the two study groups (FMF patients and the control group) and the results will be compared. It will be conducted in Assiut University Neurosonology Unit, at the Department of Neurology. Receives: Radiation: ultrasound on carotid |
What is being measured
The primary outcome is the main question the study is designed to answer.
detecting subclinical atheroscelerosis
The aim of this study is to detect subclinical
atherosclerosis in children diagnosed as FMF in Assiut University children's Hospital by measuring carotid intima thickness
Measured: It will be measured in one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Dec 2023 (estimated)
- Primary completion14 Sep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FMFStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali AbdElhaleem Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047938
- Sponsor's protocol ID
- FMF and atheroscelerosis
- Status last verified
- Oct 2023
- First submitted
- 12 Jul 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Mediteranean Fever in Upper Egypt, and Its Relation to Atherosclerosis in Children
- ClinicalTrials.gov ID
- NCT06047938
- Acronym / sponsor ID
- FMF and atheroscelerosis
- Conditions
- FMF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 14 Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
The aim of this study is to search for subclinical atherosclerosis in children diagnosed as FMF in Assiut University children's Hospital, and to correlate the risk to develop atherosclerosis to the different characters and genetic variants of FMF.
Detailed description
- To describe the clinical characteristics of patients diagnosed as FMF in Upper Egypt, and to find the most common presenting symptoms.
- To mention the most common genetic variants reported in FMF patients in Upper Egypt, and to correlate the genetic variant with the risk to develop atherosclerosis.
- To assess the growth parameters in patients with FMF and compare it with the control group.
- To estimate the differences in Complete blood count (CBC) parameters, lipid profile, CIT in patients with FMF and control group.
- To search for subclinical atherosclerosis in patients with FMF based on their lipid profile and CIT.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carotid intima thickness measurment | – | Radiation: ultrasound on carotidCIT will be assessed using ultrasound evaluation by measuring the intima-media thickness of carotid arteries (IMT). This non-invasive method is used to detect subclinical atherosclerosis and it can be used in a multitude of patients including children. It will be carried out on the two study groups (FMF patients and the control group) and the results will be compared. It will be conducted in Assiut University Neurosonology Unit, at the Department of Neurology. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All patients that present with FMF in Assiut University Pediatric Hospital (allergy , immunology and rheumatology department)in one year.
Key inclusion criteria (3 listed)
- Age at enrollment less than18 years.
- Both sexes.
- Diagnosed as familial Mediterranean fever according to Tel Hashomer criteria. [10]
Key exclusion criteria (4 listed)
- Patients with acute or chronic active infections.
- Patients with pre-existing illness as chronic lung, liver or renal diseases.
- Patients with diabetes mellitus, atherosclerotic vascular disease.
- Patients with malignancy
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 |
|---|---|---|
| ultrasound on carotidCIT will be assessed using ultrasound evaluation by measuring the intima-media thickness of carotid arteries (IMT). This non-invasive method is used to detect subclinical atherosclerosis and it can be used in a multitude of patients including children[11]. It will be carried out on the two study groups (FMF patients and the control group) and the results will be compared. It will be conducted in Assiut University Neurosonology Unit, at the Department of Neurology. | Radiation | carotid intima thickness measurment |
Primary outcome
detecting subclinical atheroscelerosis
Time frame: It will be measured in one year
The aim of this study is to detect subclinical atherosclerosis in children diagnosed as FMF in Assiut University children's Hospital by measuring carotid intima thickness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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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.
Naglaa mohamed samy, lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of FMF, run by Assiut University.
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 3 inclusion and 4 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 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Ali Abdelhaleem Hussein, bachelor (01125023042, ali.naroto777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detecting subclinical atheroscelerosis (time frame: It will be measured in one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2023.