Clinical trial NCT02829580: Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound
Official title: Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: endothelial function
flow-mediated dilation
vascular elastic properties
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 31
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of endothelial function
timeFrame: baseline
Secondary outcomes:
measure: match the measurement thickness of the intima media
timeFrame: baseline
measure: match the measurement systolic and diastolic diameters
timeFrame: baseline
measure: distensibility cross sectional
timeFrame: baseline
measure: Match the measurement on the diastolic wall stress
timeFrame: baseline
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: DULAC YVES, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hadeed K, Hascoet S, Castex MP, Munzer C, Acar P, Dulac Y. Endothelial Function and Vascular Properties in Children with Sickle Cell Disease. Echocardiography. 2015 Aug;32(8):1285-90. doi: 10.1111/echo.12851. Epub 2014 Dec 3.