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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02829580
Enrollment
31
Registered
2016-07-12
Start date
2008-09-30
Completion date
2013-02-28
Last updated
2017-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

endothelial function, flow-mediated dilation, vascular elastic properties

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.

Interventions

PROCEDUREEchocardiography

Measures by Doppler and study of endothelial function

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of endothelial functionbaselineEvaluation parameter of endothelial function (brachial artery): flow dependent dilatation (expressed in%)

Secondary

MeasureTime frameDescription
match the measurement thickness of the intima mediabaselineThe thickness of the intima media (ITM) on the right common carotid
match the measurement systolic and diastolic diametersbaselinesystolic and diastolic diameters (sD, dD)
distensibility cross sectionalbaselinematch the measurement on the compliance and distensibility cross sectional (CCS, DCS)
Match the measurement on the diastolic wall stressbaselinediastolic wall stress (DWS)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026