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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829580
• Other study ID #: 07 307 02
• Secondary ID: 07 307 02
• Status: Completed
• Phase: N/A
• First received: July 4, 2016
• Last updated: May 10, 2017
• Start date: September 2008
• Est. completion date: February 2013

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Procedure:
• Echocardiography
Measures by Doppler and study of endothelial function

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of endothelial function	Evaluation parameter of endothelial function (brachial artery): flow dependent dilatation (expressed in%)	baseline
Secondary	match the measurement thickness of the intima media	The thickness of the intima media (ITM) on the right common carotid	baseline
Secondary	match the measurement systolic and diastolic diameters	systolic and diastolic diameters (sD, dD)	baseline
Secondary	distensibility cross sectional	match the measurement on the compliance and distensibility cross sectional (CCS, DCS)	baseline
Secondary	Match the measurement on the diastolic wall stress	diastolic wall stress (DWS)	baseline