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

May 10, 2017 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of endothelial function
Time Frame: baseline
Evaluation parameter of endothelial function (brachial artery): flow dependent dilatation (expressed in%)
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07 307 02 (Other Identifier: Local grant)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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