Heart, Arteries and Sikle Cell Disease, a Multicentric Cohort of Cardiovascular Complications in Subsaharan Africa
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,500
- 试验地点
- 13
- 主要终点
- Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: cardiopathy
研究概览
简要总结
The CADRE study is a multinational observational cohort of patients with sickle-cell disease (SCD) in five west and central sub-Saharan African countries. The aim of this project is to describe the incidence and assess the predictive factors of SCD-related micro- and macro-vascular complications in sub-Saharan Africa.
详细描述
Sickle cell disease (SCD), one of the lost common genetic diseases worldwide, is caused by a mutation in the β globin gene. Most patients with this disease are homozygous for the βS allele (SS), whereas others have inherited a βS allele with another mutation in the β globin gene. In addition to repeated acute ischemic insults due to the red blood cells sickling in the microcirculation, a chronic vasculopathy leads to organ injuries, such as kidney disease, stroke, pulmonary hypertension, retinopathy, bone infarcts, and leg ulcers.
CADRE is a multinational prospective observational study undertaken in five countries in sub-Saharan Africa. Patients with SCD will be recruited through outpatients' clinics in public, university and private hospitals and research centers in five countries. The CADRE protocol was approved by the relevant national ethics committee in each of the participating countries.
Primary endpoint is to measure the prevalence and the incidence of the main vascular complications in the main types of SCD: glomerulopathy, nephropathy, cardiopathy, pulmonary hypertension, retinopathy, strokes, osteonecrosis and leg ulcers.
Secondary endpoints are:
- to define the clinical and biological predictors of SCD vasculopathy in Africa
- to search for genetic risk factors for the SCD-related cardiovascular complications, in particular alpha thalassemia, persistence of foetal hemoglobin and other candidate genetic polymorphisms
- to search for functional risk factors (pulse wave velocity, capillary vasodilatation, blood visosity) for the SCD-related cardiovascular complications
- to search for new biological determinant of SCD-related cardiovascular complications, in particular alternative markers of hemolysis (microparticules, free heme) and inflammation (cytokines, leucocytes phenotyping, NET (neutrophile extracellular traps))
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: five-year-old or more
- •signature of informed consent Patients : major sickle cell syndrome confirmed by hemoglobin phenotyping: SS, SC, SBeta+ or Sbeta0 Controls : healthy parents or siblings of the patients, hospital staff or their children, matched on age+/- 3 years and country (1 control for 4 patients)
排除标准
- •unstable clinical status such as:
- •vaso-occlusive crisis in the previous 15 days
- •fever or infectious disease in the previous 15 days
- •transfusion in the previous 2 months
结局指标
主要结局
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: cardiopathy
时间窗: 10 years
left ventricular ejection fraction \< 60 %
Prevalence and incidence and the 10 year-incidence of the main SCD-related vascular complications in different phenotypes of SCD: retinopathy
时间窗: 10 years
retinal examination
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: leg ulcers
时间窗: 10 years
clinical diagnosis
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:osteonecrosis
时间窗: 10 years
standard radiography
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:stroke
时间窗: 10 years
clinical diagnosis
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: glomerulopathy
时间窗: 10 years
urinary albumin/creatinin ratio (mg/g)
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: pulmonary hypertension
时间窗: 10 years
tricuspid regurgitation jet velocity (m/s)
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: priapism
时间窗: 10 years
clinical diagnosis
次要结局
- Potential biological risk marker measured at baseline and follow up visits: complete blood count(10 years)
- Potential biological risk marker measured at baseline and follow up visits: neutrophil extracellular traps(10 years)
- Potential biological risk marker measured at baseline and follow up visits: carotid-femoral pulse wave velocity(10 years)
- Potential biological risk marker measured at baseline and follow up visits: LDH level(10 years)
- Potential biological risk marker measured at baseline and follow up visits: bilirubin level(10 years)
- Potential biological risk marker measured at baseline and follow up visits: microparticules measure(10 years)
- Potential biological risk marker measured at baseline and follow up visits: free heme level(10 years)
- Potential biological risk marker measured at baseline and follow up visits: inflammatory cytokines(10 years)
研究者
Xavier Jouven
Professor
Cardiologie et Développement