Sickle Cell DiseaseNCT02829580
Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound
A study testing Echocardiography in people with Sickle Cell Disease, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sickle Cell Disease
- Being tested
- Echocardiography
- Keywords
- endothelial function, flow-mediated dilation, vascular elastic properties
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyProcedure or surgery
Measures by Doppler and study of endothelial function
| Study group | Role | What they receive |
|---|---|---|
| Sickle group | Experimental | Children with major sickle cell syndrome will have an usual Echocardiography Receives: Procedure: Echocardiography |
| Control group | Active comparator | Children recruited in a previous study and who had an usual Echocardiography Receives: Procedure: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of endothelial function
Evaluation parameter of endothelial function (brachial artery): flow dependent dilatation (expressed in%)
Measured: baseline
Secondary outcomes (4)
match the measurement thickness of the intima media
The thickness of the intima media (ITM) on the right common carotid
Measured: baseline
match the measurement systolic and diastolic diameters
systolic and diastolic diameters (sD, dD)
Measured: baseline
distensibility cross sectional
match the measurement on the compliance and distensibility cross sectional (CCS, DCS)
Measured: baseline
Match the measurement on the diastolic wall stress
diastolic wall stress (DWS)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startSep 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DULAC YVES, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829580
- Sponsor's protocol ID
- 07 307 02
- Other IDs
- 07 307 02
- Status last verified
- May 2017
- First submitted
- 4 Jul 2016
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 25470331
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound
- ClinicalTrials.gov ID
- NCT02829580
- Acronym / sponsor ID
- 07 307 02
- Conditions
- Sickle Cell Disease
- Keywords
- endothelial function, flow-mediated dilation, vascular elastic properties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sickle group | Experimental | Procedure: EchocardiographyChildren with major sickle cell syndrome will have an usual Echocardiography |
| Control group | Active comparator | Procedure: EchocardiographyChildren recruited in a previous study and who had an usual Echocardiography |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
- Children with intercurrent diseases: obesity, IUGR, hypertension, renal failure, infectious diseases (including HIV, Hepatitis C) or chronic inflammatory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyMeasures by Doppler and study of endothelial function | Procedure or surgery | Control group, Sickle group |
Primary outcome
Evaluation of endothelial function
Time frame: baseline
Evaluation parameter of endothelial function (brachial artery): flow dependent dilatation (expressed in%)
4 secondary outcomes
match the measurement thickness of the intima media
Time frame: baseline
match the measurement systolic and diastolic diameters
Time frame: baseline
distensibility cross sectional
Time frame: baseline
Match the measurement on the diastolic wall stress
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Results publication: PubMed 25470331Hadeed 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DULAC YVES, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography in people with Sickle Cell Disease, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of endothelial function (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02829580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.