Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound

Study Overview
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Brief Summary
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Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances such as nitric oxide. The present study assess the vascular properties of carotid and brachial arteries in children with SCD compared with a control group without cardiovascular risk factors.

Official Title
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Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Procedure: Echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sickle cell group : Children with sickle cell syndrome (SS or SC) Children hospitalized in the hematology unit (day hospital) The girls set must have had a negative pregnancy test. One of the two holders of parental authority must have signed consent form Children affiliated to a social security scheme or equivalent Control group : Children recruited in a previous study : Holders of parental authority affiliated to a social security scheme Children recruited during the balance of a heart murmur or a vasovagal reaction Children whose cardiological examination is normal Children having no cardiovascular risk factor Exclusion Criteria: Sickle cell group : Children with intercurrent diseases such as obesity, intra uterine growth retardation (IUGR), hypertension, renal failure, infectious diseases (including HIV, Hepatitis C) or chronic inflammatory Children who have sickle cell crisis there is less than 1 month. Control group : Children with intercurrent diseases: obesity, IUGR, hypertension, renal failure, infectious diseases (including HIV, Hepatitis C) or chronic inflammatory

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sickle group<br>Children with major sickle cell syndrome will have an usual Echocardiography | Procedure: Echocardiography<br>* Measures by Doppler and study of endothelial function<br>|
| Active Comparator: Control group<br>Children recruited in a previous study and who had an usual Echocardiography | Procedure: Echocardiography<br>* Measures by Doppler and study of endothelial function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of endothelial function | Evaluation parameter of endothelial function (brachial artery): flow dependent dilatation (expressed in%) | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| match the measurement thickness of the intima media | The thickness of the intima media (ITM) on the right common carotid | baseline | 
| match the measurement systolic and diastolic diameters | systolic and diastolic diameters (sD, dD) | baseline | 
| distensibility cross sectional | match the measurement on the compliance and distensibility cross sectional (CCS, DCS) | baseline | 
| Match the measurement on the diastolic wall stress | diastolic wall stress (DWS) | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, flow-mediated dilation, vascular elastic properties