FMF and Atheroscelerosis

Not yet recruiting

• Conditions: FMF
• Interventions: Radiation: ultrasound on carotid

• Registration Number: NCT06047938
• Lead Sponsor: Assiut University

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.

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 Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13
• Study Start: 2023-12-15
• Primary Completion: 2024-09-14
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age at enrollment less than18 years.
2. Both sexes.
3. Diagnosed as familial Mediterranean fever according to Tel Hashomer criteria. [10]

Exclusion Criteria

1. Patients with acute or chronic active infections.
2. Patients with pre-existing illness as chronic lung, liver or renal diseases.
3. Patients with diabetes mellitus, atherosclerotic vascular disease.
4. Patients with malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
carotid intima thickness measurment	ultrasound on carotid	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.

Primary Outcome Measures

Name	Time	Method
detecting subclinical atheroscelerosis	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