FMF and Atheroscelerosis

NCT ID: NCT06047938

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-12-31

Brief Summary

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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

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* 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

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FMF

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

ultrasound on carotid

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ali AbdElhaleem Hussein

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ali Abdelhaleem Hussein, bachelor

Role: CONTACT

01125023042

Naglaa mohamed samy, lecturer

Role: CONTACT

01002673103

Other Identifiers

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FMF and atheroscelerosis

Identifier Type: -

Identifier Source: org_study_id

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