NCT02829580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

4.4 years

First QC Date

July 4, 2016

Last Update Submit

May 10, 2017

Conditions

Sickle Cell Disease

Keywords

endothelial functionflow-mediated dilationvascular elastic properties

Outcome Measures

Primary Outcomes (1)

  • Evaluation of endothelial function

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

    baseline

Secondary Outcomes (4)

  • match the measurement thickness of the intima media

    baseline

  • match the measurement systolic and diastolic diameters

    baseline

  • distensibility cross sectional

    baseline

  • Match the measurement on the diastolic wall stress

    baseline

Study Arms (2)

Sickle group

EXPERIMENTAL

Children with major sickle cell syndrome will have an usual Echocardiography

Procedure: Echocardiography

Control group

ACTIVE COMPARATOR

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

Procedure: Echocardiography

Interventions

EchocardiographyPROCEDURE

Measures by Doppler and study of endothelial function

Control groupSickle group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

Related 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.

    PMID: 25470331RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • DULAC YVES, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 12, 2016

Study Start

September 1, 2008

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

FR(1)