FMF and Atheroscelerosis

October 12, 2023 updated by: Ali AbdElhaleem Hussein, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Naglaa mohamed samy, lecturer
  • Phone Number: 01002673103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients that present with FMF in Assiut University Pediatric Hospital (allergy , immunology and rheumatology department)in one year.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
It will be measured in one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2023

Primary Completion (Estimated)

September 14, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • FMF and atheroscelerosis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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