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Clinical Trials/NCT02829580
NCT02829580
Completed
Not Applicable

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

University Hospital, Toulouse1 site in 1 country31 target enrollmentSeptember 2008
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ConditionsSickle Cell Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sickle Cell Disease
Sponsor
University Hospital, Toulouse
Enrollment
31
Locations
1
Primary Endpoint
Evaluation of endothelial function
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
February 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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

Outcomes

Primary Outcomes

Evaluation of endothelial function

Time Frame: baseline

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

Secondary Outcomes

  • match the measurement systolic and diastolic diameters(baseline)
  • Match the measurement on the diastolic wall stress(baseline)
  • match the measurement thickness of the intima media(baseline)
  • distensibility cross sectional(baseline)

Study Sites (1)

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