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

Not Applicable

Completed

• Conditions: Sickle Cell Disease
• Interventions: Procedure: Echocardiography

• Registration Number: NCT02829580
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Echocardiography	Children recruited in a previous study and who had an usual Echocardiography
Sickle group	Echocardiography	Children with major sickle cell syndrome will have an usual Echocardiography

Primary Outcome Measures

Name	Time	Method
Evaluation of endothelial function	baseline	Evaluation parameter of endothelial function (brachial artery): flow dependent dilatation (expressed in%)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France