Determinants of Cerebral Oxygenation and Perfusion in SCA Children Based on Combined ASL MRI, NIRS and Hemorheological Investigation
Sickle Cell Anemia and Cerebral Microcirculation : Multimodal Exploration
Sponsors
Source
Imagine Institute
Oversight Info
Has Dmc
No
Brief Summary
The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at
the microcirculatory level in children with sickle cell anemia (SCA) using combined novel
investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance)
imaging, brain Near Infra-Red Spectroscopy (NIRS) and red blood cell (RBC) rheological
properties.
Detailed Description
The investigators hypothesize that brain perfusion and/or oxygenation modifications may be
evidenced in SCA children who have no microarteriopathy and may correlate with
hemorheological abnormalities and impaired vasomotion. A multimodal approach designed to
study a. cerebral perfusion and oxygenation, b. flow motion properties and c. blood
rheological parameters might help to describe the different processes involved in cerebral
ischemia.
Overall Status
Completed
Start Date
2015-03-02
Completion Date
2017-07-11
Primary Completion Date
2017-07-11
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Number of patients on which we detect default of cerebral perfusion (in order to correlate them with other clinical or biological parameters) |
1.5 years |
Secondary Outcome
Measure |
Time Frame |
|
Bifrontal cerebral hemoglobin oxygen saturation |
1.5 years |
|
Description of the global assessment of RBC deformability |
1.5 years |
Number Of Groups
1
Enrollment
64
Condition
Intervention
Intervention Type
Procedure
Intervention Name
Description
Blood samples collection (for DNA, plasma and cells analyzes) ; Hemorheologic analyzes ; ASL sequence on MRI ; Near Infra Red Spectroscopy (NIRS) and associated cardiofrequency analyze.
Arm Group Label
Sickle cell disease patients
Eligibility
Study Pop
Patient included will be patients suffering from Sickle Cell Anemia, and coming at the
study center in the frame of their annual follow-up visit.
Sampling Method
Probability Sample
Criteria
Inclusion Criteria:
- SS or S-beta° genotype;
- age 6-16 years;
- steady state;
- normal TCD (Transcranial Doppler);
- parental study approval and written informed consent.
Exclusion Criteria:
- SC, Sbeta+, SD Punjab genotype
- history of overt stroke,
- intracranial or cervical arterial stenosis,
- abnormal TCD at the time of the study.
Gender
All
Minimum Age
6 Years
Maximum Age
16 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Valentine Boursse |
Principal Investigator |
Hôpital Necker-Enfants Malades |
|
Suzanne Verlhac |
Study Director |
Centre Hospitalier Intercommunal de Créteil |
Location
Facility |
|
Centre Hospitalier Intercommunal Créteil France |
|
Necker - Enfants Malades hospital Paris France |
Location Countries
Country
France
Verification Date
2018-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Arm Group
Arm Group Label
Sickle cell disease patients
Description
Physical exams and blood analyzes
Firstreceived Results Date
N/A
Biospec Retention
Samples With DNA
Biospec Descr
Blood samples are taken, in order to create Biobank (DNA, serum and plasma)
Acronym
DREAM²
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Case-Only
Time Perspective
Prospective
Study First Submitted
September 5, 2016
Study First Submitted Qc
September 16, 2016
Study First Posted
September 21, 2016
Last Update Submitted
November 12, 2018
Last Update Submitted Qc
November 12, 2018
Last Update Posted
November 14, 2018
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.