Sickle Cell Disease
Conditions
Brief summary
The purpose of this study is to evaluate the relationship between plasma DNA levels and micro- and macro-circulatory vascular remodelling in patients with sickle cell disease
Interventions
PROCEDUREmicro- and macro-circulatory vascular remodelling measures not practice in routine care
Vascular measures : reactive hyperaemia index (RHI) assessed by Endo-PAT, central aortic blood pressure, aortic augmentation index, carotid-femoral pulse wave velocity
PROCEDUREBiological measures not practice in routine care
Biological measures : Plasma DNA level, NETs (plasma nucleosome levels), Microparticules (MPs) (total, associated with red blood cells, neutrophils, platelets), haem (total and bound to MPs), Myeloperoxydase and elastase activity, neutrophils/DNA, Annexin A5, RNA and TSP1
Sponsors
Theravia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Homozygous SS or Sß0 sickle cell disease patients. * Seen in consultation for an annual clinical and para-clinical evaluation of his/her disease. * Stable clinical condition of the disease defined as the absence of severe vaso-occlusive crises (requiring hospitalisation or a visit to the emergency unit) in the previous month and absence of transfusion in the previous 3 months.
Exclusion criteria
* Other haemoglobinopathy * Known diabetes. * Recent administration of an anticoagulant treatment at curative doses (\< 48h before inclusion), or platelet-inhibiting drugs (less than 1 week prior to inclusion). * Recent transfusion (less than 3 months prior to inclusion). * Pregnancy or post-partum (first 40 days after giving birth). * Recent consumption of alcohol (less than 10h), coffee (less than 3h), and tobacco (less than 36h) before inclusion. * Known infection with hepatitis B, C, and HIV infection. * Known cancer or progressive blood disease. * Known haemostasis or coagulation disorders. * Progressive inflammatory or infectious diseases. * Recent history (dating less than 3 months) of venous (pulmonary embolism, deep venous thrombosis) or arterial (acute coronary syndrome, stroke, peripheral arterial ischaemia) thromboembolic event. * Adult patients subject to legal protection measures. * Patients already involved in a therapeutic protocol. * Patients not affiliated to a social security system. * Non-inclusion criteria related to the technical requirements of the Endo-PAT: * Known cardiac arrhythmia. * Severe Raynaud's syndrome. * Hand or arm deformity that prevents an EndoPAT analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of plasma DNA levels in patients with a reactive hyperaemia index (RHI) < 1.67 (endothelial dysfunction) assessed by Endo-PAT 2000 versus those recorded in patients with a RHI ≥ 1.67 (no endothelial dysfunction) | 1 days |
Secondary
| Measure | Time frame |
|---|---|
| Relationship between plasma DNA levels and cardiac damages | 1 day |
| Relationship between plasma DNA levels and pulmonary blood pressure | 1 day |
| Relationship between plasma DNA levels and cerebral micro- and macro-angiopathy assessed by CT angiography or MRI angiography and transcranial Doppler ultrasound | 1 day |
| Relationship between plasma DNA levels and nephropathy | 1 day |
| Relationship between plasma DNA levels and a clinical index of the sickle cell disease severity in a stable condition | 1 day |
| Relationship between plasma DNA levels and macrocirculatory vascular measurements | 2 days |
Countries
France
Outcome results
None listed