FMF and Atheroscelerosis

FMF Clinical Trial

Official title:

Familial Mediteranean Fever in Upper Egypt, and Its Relation to Atherosclerosis in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06047938
• Other study ID #: FMF and atheroscelerosis
• Status: Not yet recruiting
• Start date: December 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Ali Abdelhaleem Hussein, bachelor
• Phone: 01125023042
• Email: ali.naroto777[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: September 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• FMF

Intervention

Radiation:
• 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[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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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