search
Back to results

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

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echocardiography
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sickle Cell Disease focused on measuring endothelial function, flow-mediated dilation, vascular elastic properties

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sickle group

Control group

Arm Description

Children with major sickle cell syndrome will have an usual Echocardiography

Children recruited in a previous study and who had an usual Echocardiography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 4, 2016
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT02829580
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
endothelial function, flow-mediated dilation, vascular elastic properties

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sickle group
Arm Type
Experimental
Arm Description
Children with major sickle cell syndrome will have an usual Echocardiography
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Children recruited in a previous study and who had an usual Echocardiography
Intervention Type
Procedure
Intervention Name(s)
Echocardiography
Intervention Description
Measures by Doppler and study of endothelial function
Primary Outcome Measure Information:
Title
Evaluation of endothelial function
Description
Evaluation parameter of endothelial function (brachial artery): flow dependent dilatation (expressed in%)
Time Frame
baseline
Secondary Outcome Measure Information:
Title
match the measurement thickness of the intima media
Description
The thickness of the intima media (ITM) on the right common carotid
Time Frame
baseline
Title
match the measurement systolic and diastolic diameters
Description
systolic and diastolic diameters (sD, dD)
Time Frame
baseline
Title
distensibility cross sectional
Description
match the measurement on the compliance and distensibility cross sectional (CCS, DCS)
Time Frame
baseline
Title
Match the measurement on the diastolic wall stress
Description
diastolic wall stress (DWS)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DULAC YVES, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25470331
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs