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OpenTrials
Completed

NCT Number: NCT02829580

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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, 31000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Procedure

Measures by Doppler and study of endothelial function

Primary outcomes

  1. Evaluation of endothelial function

    Time frame: baseline

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2016
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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