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

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ClinicalTrials.gov Identifier: NCT02829580
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Procedure: Echocardiography Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound
Study Start Date : September 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sickle group
Children with major sickle cell syndrome will have an usual Echocardiography
 Procedure: Echocardiography
Measures by Doppler and study of endothelial function
Active Comparator: Control group
Children recruited in a previous study and who had an usual Echocardiography
 Procedure: Echocardiography
Measures by Doppler and study of endothelial function


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of endothelial function [ Time Frame: baseline ]
    Evaluation parameter of endothelial function (brachial artery): flow dependent dilatation (expressed in%)


Secondary Outcome Measures :
  1. match the measurement thickness of the intima media [ Time Frame: baseline ]
    The thickness of the intima media (ITM) on the right common carotid

  2. match the measurement systolic and diastolic diameters [ Time Frame: baseline ]
    systolic and diastolic diameters (sD, dD)

  3. distensibility cross sectional [ Time Frame: baseline ]
    match the measurement on the compliance and distensibility cross sectional (CCS, DCS)

  4. Match the measurement on the diastolic wall stress [ Time Frame: baseline ]
    diastolic wall stress (DWS)


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829580


Locations
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France
University Hospital of Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: DULAC YVES, MD University Hospital, Toulouse
More Information
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Publications of Results:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02829580    
Other Study ID Numbers: 07 307 02
07 307 02 ( Other Identifier: Local grant )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Toulouse:
endothelial function
flow-mediated dilation
vascular elastic properties
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn