Heart Arteries and Sickle Cell Disease / Coeur Artères DREpanocytose
- Conditions
- Sickle Cell AnemiaSickle Cell Disease
- Registration Number
- NCT03114137
- Lead Sponsor
- Cardiologie et Développement
- Brief Summary
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.
- Detailed Description
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))
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4500
- 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)
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: cardiopathy 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 10 years retinal examination
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: leg ulcers 10 years clinical diagnosis
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:osteonecrosis 10 years standard radiography
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:stroke 10 years clinical diagnosis
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: glomerulopathy 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 10 years tricuspid regurgitation jet velocity (m/s)
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: priapism 10 years clinical diagnosis
- Secondary Outcome Measures
Name Time Method Potential biological risk marker measured at baseline and follow up visits: inflammatory cytokines 10 years 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 measured by Pulsepen, m/s)
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
Trial Locations
- Locations (13)
Centre de Recherche et de Lutte contre la Drepanocytose
🇲🇱Bamako, Mali
Hematology Unit, CHU Yopougon
🇨🇮Abidjan, Côte D'Ivoire
Centre mère et enfant / fondation Chantal Biya
🇨🇲Yaounde, Cameroon
CIRMF
🇬🇦Libreville, Gabon
Cardiology Unit, Centre gyneco-obstretrique
🇲🇱Bamako, Mali
Centre national de transfusion sanguine
🇸🇳Dakar, Senegal
Pediatrics unit, Centre Hospitalier d'Essos
🇨🇲Yaounde, Cameroon
Central Hospital of Yaounde
🇨🇲Yaounde, Cameroon
Centre Pasteur du Cameroun
🇨🇲Yaounde, Cameroon
Centre hospitalier Monkole
🇨🇩Kinshasa, Congo, The Democratic Republic of the
Institut de cardiologie
🇨🇮Abidjan, Côte D'Ivoire
Centre hospitalier d'enfants Albert Royer
🇸🇳Dakar, Senegal
Centre hospitalo-universotaire de Fann, Cardiology department
🇸🇳Dakar, Senegal