Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05780775
Status:
RECRUITING
Last Update Posted:
2023-03-23
First Post:
2022-12-12
Brief Title:
Lipid Balance in Adult Sickle Cell Patients
Sponsor:
Centre Hospitalier Universitaire de Pointe-a-Pitre
Organization:
Centre Hospitalier Universitaire de Pointe-a-Pitre
Study Overview
Official Title:
Study of Lipid Balance in Adult Sickle Cell SS or SC Patients at Steady State and According to Clinical Phenotypes and During Acute Complications Acronym HDL2
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HDL2
Brief Summary:
This study aims to describe andor searches for in cohorts of adult sickle cell anemia SCA and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers 1-lipids profiles and associations at steady state with occurrence of sickle cell disease SCD complications 2-lipids profile evolution during and after prospective acute complications vasoocclusive crises VOC and priapism 3-lipids profile variation inter intra individuals during 4 prospective years 4- Genetic primary modulators of SCD complications 5- insulin resistance HOMA free fatty acids and glycerol dosages 6- lipids enzymes lipidome and functionality of HDL in sub-groups of SCD population
Detailed Description:
Cohorts of sickle cell disease patients including sickle cell anemia SCA and SC sickle cell patients living in Guadeloupe and Martinique and followed by the Sickle cell disease SCD Reference and Competence Centers of French West Indies
Lipid profile includes total cholesterol HDL-cholesterol non-HDL-cholesterol LDL-cholesterol and triglycerides apolipoprotein A-I and B
Medical histories and prospective collection of SCD complications include retinopathy deafness tinnitus osteonecrosis leg ulcers strokes acute chest syndrome VOC priapism pulmonary arterial hypertension PAH and PAH sd echocardiography diagnosed when tricuspid regurgitant jet velocity 25 msec kidney disease chronic renal insufficiency andor nephropathy
Objective 4 to describe genetic primary modulators of SCD complications fetal hemoglobin alpha-thalassemia haplotypes of beta S gene
Objective 5 will be performed in the entire cohort at inclusion and during prospective complications VOC priapism
Objective 6 will be performed in a sub-group of 90 individuals n15 with VOC and n 15 without VOC n15 with priapism and n15 without priapism n 15 with pulmonary arterial hypertension syndrome PAH Sd and n15 without PAH Sd as well as in a subgroup of n 15 patients prospectively experiencing VOC and n 15 patients prospectively experiencing priapism
A collection of plasma is performed to fulfill objective 6 as well as a collection of blood cells for later researches
Lipid profile includes total cholesterol HDL-cholesterol non-HDL-cholesterol LDL-cholesterol and triglycerides apolipoprotein A-I and B
Medical histories and prospective collection of SCD complications include retinopathy deafness tinnitus osteonecrosis leg ulcers strokes acute chest syndrome VOC priapism pulmonary arterial hypertension PAH and PAH sd echocardiography diagnosed when tricuspid regurgitant jet velocity 25 msec kidney disease chronic renal insufficiency andor nephropathy
Objective 4 to describe genetic primary modulators of SCD complications fetal hemoglobin alpha-thalassemia haplotypes of beta S gene
Objective 5 will be performed in the entire cohort at inclusion and during prospective complications VOC priapism
Objective 6 will be performed in a sub-group of 90 individuals n15 with VOC and n 15 without VOC n15 with priapism and n15 without priapism n 15 with pulmonary arterial hypertension syndrome PAH Sd and n15 without PAH Sd as well as in a subgroup of n 15 patients prospectively experiencing VOC and n 15 patients prospectively experiencing priapism
A collection of plasma is performed to fulfill objective 6 as well as a collection of blood cells for later researches
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None