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Heart Arteries and Sickle Cell Disease / Coeur Artères DREpanocytose (CADRE)

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ClinicalTrials.gov Identifier: NCT03114137
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : May 25, 2018
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
University of Paris 5 - Rene Descartes
laboratory of excellence GR-Ex
Information provided by (Responsible Party):
Xavier Jouven, 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.

Condition or disease
Sickle Cell Anemia Sickle Cell Disease

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))

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Heart, Arteries and Sikle Cell Disease, a Multicentric Cohort of Cardiovascular Complications in Subsaharan Africa
Actual Study Start Date : March 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort
sickle cell patients
  • age: five-year-old or more
  • major sickle cell syndrome confirmed by hemoglobin phenotype: SS, SC, SBeta+ or Sbeta0
  • steady state defined as the absence of vaso-occlusive crisis for the previous 15 days, absence of fever or infectious disease for the previous 8 days and absence of transfusion for the previous 2 months
control patients
  • volunteer parents or siblings of sickle cell patients
  • hospital staff or their children matched on country and age +/- 3 ans with the patients



Primary Outcome Measures :
  1. Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: glomerulopathy [ Time Frame: 10 years ]
    urinary albumin/creatinin ratio (mg/g)

  2. Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: cardiopathy [ Time Frame: 10 years ]
    left ventricular ejection fraction < 60 %

  3. Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: pulmonary hypertension [ Time Frame: 10 years ]
    tricuspid regurgitation jet velocity (m/s)

  4. Prevalence and incidence and the 10 year-incidence of the main SCD-related vascular complications in different phenotypes of SCD: retinopathy [ Time Frame: 10 years ]
    retinal examination

  5. Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:stroke [ Time Frame: 10 years ]
    clinical diagnosis

  6. Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:osteonecrosis [ Time Frame: 10 years ]
    standard radiography

  7. Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: leg ulcers [ Time Frame: 10 years ]
    clinical diagnosis

  8. Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: priapism [ Time Frame: 10 years ]
    clinical diagnosis


Secondary Outcome Measures :
  1. Potential biological risk marker measured at baseline and follow up visits: carotid-femoral pulse wave velocity [ Time Frame: 10 years ]
    measured by Pulsepen, m/s)

  2. Potential biological risk marker measured at baseline and follow up visits: complete blood count [ Time Frame: 10 years ]
  3. Potential biological risk marker measured at baseline and follow up visits: LDH level [ Time Frame: 10 years ]
  4. Potential biological risk marker measured at baseline and follow up visits: bilirubin level [ Time Frame: 10 years ]
  5. Potential biological risk marker measured at baseline and follow up visits: microparticules measure [ Time Frame: 10 years ]
  6. Potential biological risk marker measured at baseline and follow up visits: free heme level [ Time Frame: 10 years ]
  7. Potential biological risk marker measured at baseline and follow up visits: inflammatory cytokines [ Time Frame: 10 years ]
  8. Potential biological risk marker measured at baseline and follow up visits: neutrophil extracellular traps [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
whole blood plasma saliva urines


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children and adult patients with the sickle cell disease living in subSaharan Africa
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114137


Contacts
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Contact: Brigitte Ranque, MD PhD brigitte.ranque@aphp.fr
Contact: Louise Boyer-Chatenet, MS +33156093656 louise.boyer-chatenet-ext@aphp.fr

Locations
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Cameroon
Central Hospital of Yaounde Recruiting
Yaounde, Cameroon
Contact: Françoise Ngo Sacks, MD         
Principal Investigator: Samuel Kingue, MD         
Sub-Investigator: Françoise Ngo Sacks, MD         
Centre mère et enfant / fondation Chantal Biya Recruiting
Yaounde, Cameroon
Contact: David Chelo, MD         
Principal Investigator: David Chelo, MD         
Sub-Investigator: Anasthasie Alima, MD         
Centre Pasteur du Cameroun Recruiting
Yaounde, Cameroon
Contact: Suzanne Belinga, MD         
Principal Investigator: Suzanne Belinga, MD         
Pediatrics unit, Centre Hospitalier d'Essos Recruiting
Yaounde, Cameroon
Contact: guillaume Wamba, MD         
Principal Investigator: Guillaume Wamba, MD         
Congo, The Democratic Republic of the
Centre hospitalier Monkole Recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Leon Tshilolo, MD         
Principal Investigator: Leon Tshilolo, MD         
Côte D'Ivoire
Hematology Unit, CHU Yopougon Recruiting
Abidjan, Côte D'Ivoire
Contact: Aissata Tolo, MD         
Principal Investigator: Aissata Tolo, MD         
Sub-Investigator: Kouakou Boidy, MD         
Institut de cardiologie Active, not recruiting
Abidjan, Côte D'Ivoire
Gabon
CIRMF Completed
Libreville, Gabon
Mali
Cardiology Unit, Centre gyneco-obstretrique Active, not recruiting
Bamako, Mali
Centre de Recherche et de Lutte contre la Drepanocytose Recruiting
Bamako, Mali
Contact: Dapa Diallo, MD         
Principal Investigator: Dapa Diallo, MD         
Sub-Investigator: Karim Dembele, MD         
Senegal
Centre hospitalier d'enfants Albert Royer Recruiting
Dakar, Senegal
Contact: Ibrahima Diagne, MD         
Principal Investigator: Ibrahima Diagne, MD         
Sub-Investigator: Indou Deme-Ly, MD         
Centre hospitalo-universotaire de Fann, Cardiology department Recruiting
Dakar, Senegal
Contact: Bara Diop, MD         
Principal Investigator: Bara Diop, MD         
Centre national de transfusion sanguine Recruiting
Dakar, Senegal
Contact: Saliou Diop, MD         
Principal Investigator: Saliou Diop, MD         
Sponsors and Collaborators
Cardiologie et Développement
Institut National de la Santé Et de la Recherche Médicale, France
University of Paris 5 - Rene Descartes
laboratory of excellence GR-Ex
Investigators
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Principal Investigator: Xavier Jouven, MD PhD Cardiologie et Developpement

Additional Information:

Publications of Results:
Other Publications:

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Responsible Party: Xavier Jouven, Professor, Cardiologie et Développement
ClinicalTrials.gov Identifier: NCT03114137     History of Changes
Other Study ID Numbers: 002
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xavier Jouven, Cardiologie et Développement:
Sub-Saharan Africa
Sickle Cell Disease
Vasculopathy
Nephropathy
Pulmonary hypertension
cardiac disease
hemolysis
pulse wave velocity
blood viscosity

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn