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

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

Tracking Information

• First Submitted Date: July 4, 2016
• First Posted Date: July 12, 2016
• Last Update Posted Date: May 11, 2017
• Study Start Date: September 2008
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 11, 2016)

Evaluation of endothelial function [ Time Frame: baseline ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 11, 2016)

• match the measurement thickness of the intima media [ Time Frame: baseline ]
  The thickness of the intima media (ITM) on the right common carotid
• match the measurement systolic and diastolic diameters [ Time Frame: baseline ]
  systolic and diastolic diameters (sD, dD)
• distensibility cross sectional [ Time Frame: baseline ]
  match the measurement on the compliance and distensibility cross sectional (CCS, DCS)
• Match the measurement on the diastolic wall stress [ Time Frame: baseline ]
  diastolic wall stress (DWS)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound
• Official Title: Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Sickle Cell Disease

Intervention

Procedure: Echocardiography

Measures by Doppler and study of endothelial function

Study Arms

• Experimental: Sickle group
  Children with major sickle cell syndrome will have an usual Echocardiography
  Intervention: Procedure: Echocardiography
• Active Comparator: Control group
  Children recruited in a previous study and who had an usual Echocardiography
  Intervention: Procedure: Echocardiography

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 12, 2016): 31
• Original Estimated Enrollment (submitted: July 11, 2016): 64
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

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
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02829580
• Other Study ID Numbers: 07 307 02; 07 307 02 ( Other Identifier: Local grant )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: University Hospital, Toulouse
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Toulouse
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: DULAC YVES, MD; University Hospital, Toulouse

• PRS Account: University Hospital, Toulouse
• Verification Date: May 2017