FMF and Atheroscelerosis
Familial Mediteranean Fever in Upper Egypt, and Its Relation to Atherosclerosis in Children
1 other identifier
observational
50
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
December 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 13, 2023
October 1, 2023
9 months
July 12, 2023
October 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
It will be measured in one year
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
All patients that present with FMF in Assiut University Pediatric Hospital (allergy , immunology and rheumatology department)in one year.
You may qualify if:
- Age at enrollment less than18 years.
- Both sexes.
- Diagnosed as familial Mediterranean fever according to Tel Hashomer criteria. \[10\]
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 12, 2023
First Posted
September 21, 2023
Study Start
December 15, 2023
Primary Completion
September 14, 2024
Study Completion
December 1, 2024
Last Updated
October 13, 2023
Record last verified: 2023-10