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

NCT ID: NCT02829580

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sickle group

Children with major sickle cell syndrome will have an usual Echocardiography

Group Type EXPERIMENTAL

Echocardiography

Intervention Type PROCEDURE

Measures by Doppler and study of endothelial function

Control group

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

Group Type ACTIVE_COMPARATOR

Echocardiography

Intervention Type PROCEDURE

Measures by Doppler and study of endothelial function

Interventions

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Echocardiography

Measures by Doppler and study of endothelial function

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DULAC YVES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 25470331 (View on PubMed)

Other Identifiers

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07 307 02

Identifier Type: OTHER

Identifier Source: secondary_id

07 307 02

Identifier Type: -

Identifier Source: org_study_id

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