NCT06101771

Brief Summary

Aim of the study: 1- Detect common types of familial dyslipidemia. 2- Significance and relationship between Epicardial fat thickness and familial dyslipidemia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Typical duration for all trials

Status
unknown

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

September 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

September 19, 2023

Last Update Submit

October 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment epicardial fat thickness in children with familial dyslipidemia

    All cases included in the study will be evaluated by: 1. \- Fasting lipid profile: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Triglycerides (TG). (18) 2. \- Transthoracic Echocardiography.

    baseline

Study Arms (1)

dyslipidemia

Normal weight children more than 1 month and till age of 18 years that attend Assiut University children Hospital with Clinical manifestation: 1. Non-symptomatic accidentally discovered dyslipidemia. 2. Steatorrhea. 3. Fatty liver.

Diagnostic Test: echoCARDIOGRAPHY

Interventions

echoCARDIOGRAPHYDIAGNOSTIC_TEST

Assessment of epicardial fat thickness in children with familial dyslipidemia

dyslipidemia

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Setting: Tertiary care center ( Assiut University children Hospital) (AUCH) from Sep 2023 to Sep 2025. Normal weight children more than 1 month and till age of 18 years that attend Assiut University children Hospital with Clinical manifestation: 1. Non-symptomatic accidentally discovered dyslipidemia. 2. Steatorrhea. 3. Fatty liver.

You may qualify if:

  • Normal weight children more than 1 month and till age of 18 years that attend Assiut University children Hospital with Clinical manifestation:
  • Non-symptomatic accidentally discovered dyslipidemia.
  • Steatorrhea.
  • Fatty liver

You may not qualify if:

  • Patients who had poor echo window : chest deformities, chronic lung disease, pericardial and/or pleural effusion on transthoracic echocardiography, and chronic kidney disease were not included in the study.
  • \. Congenital heart diseases. 3. Children with liver diseases that cause 2ry dyslipidemia. 4. Children with Diabetes that cause 2ry dyslipidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Amr Mohamed Kotb, Lecturer of Pediatrics

    Assiut University

    STUDY DIRECTOR
  • Mohamed Abou Bakr Sobeih, Lecturer of Pediatrics

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

mina mamdoh Tadros, resident doctor

CONTACT

Faisal-Al Khateeb Al Khateeb ahmed, professor of pediatrics

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor of Pediatrics, Faculty of Medicine, Assiut University, Principal Investigator.

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 26, 2023

Study Start

December 20, 2023

Primary Completion

December 20, 2025

Study Completion

December 30, 2025

Last Updated

October 26, 2023

Record last verified: 2023-10