Heart Arteries and Sickle Cell Disease / Coeur Artères DREpanocytose

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 5 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03114137
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Cardiologie et Développement
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Xavier Jouven, MD PhD
Principal Investigator Affiliation Cardiologie et Developpement
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Cameroon, Congo, The Democratic Republic of the, Côte D'Ivoire, Gabon, Mali, Senegal
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sickle Cell Anemia, Sickle Cell Disease
Additional Details

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))

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Central Hospital of Yaounde, Yaounde, Cameroon

Status

Recruiting

Address

Central Hospital of Yaounde

Yaounde, ,

Site Contact

Françoise Ngo Sacks, MD

brigitte.ranque@aphp.fr

Yaounde, Cameroon

Status

Recruiting

Address

Centre mère et enfant / fondation Chantal Biya

Yaounde, ,

Site Contact

David Chelo, MD

brigitte.ranque@aphp.fr

Centre Pasteur du Cameroun, Yaounde, Cameroon

Status

Recruiting

Address

Centre Pasteur du Cameroun

Yaounde, ,

Site Contact

Suzanne Belinga, MD

brigitte.ranque@aphp.fr

Yaounde, Cameroon

Status

Recruiting

Address

Pediatrics unit, Centre Hospitalier d'Essos

Yaounde, ,

Site Contact

guillaume Wamba, MD

brigitte.ranque@aphp.fr

Centre hospitalier Monkole, Kinshasa, Congo, The Democratic Republic of the

Status

Recruiting

Address

Centre hospitalier Monkole

Kinshasa, ,

Site Contact

Leon Tshilolo, MD

brigitte.ranque@aphp.fr

Hematology Unit, CHU Yopougon, Abidjan, Côte D'Ivoire

Status

Recruiting

Address

Hematology Unit, CHU Yopougon

Abidjan, ,

Site Contact

Aissata Tolo, MD

brigitte.ranque@aphp.fr

Institut de cardiologie, Abidjan, Côte D'Ivoire

Status

Active, not recruiting

Address

Institut de cardiologie

Abidjan, ,

CIRMF, Libreville, Gabon

Status

Completed

Address

CIRMF

Libreville, ,

Bamako, Mali

Status

Active, not recruiting

Address

Cardiology Unit, Centre gyneco-obstretrique

Bamako, ,

Bamako, Mali

Status

Recruiting

Address

Centre de Recherche et de Lutte contre la Drepanocytose

Bamako, ,

Site Contact

Dapa Diallo, MD

brigitte.ranque@aphp.fr

Dakar, Senegal

Status

Recruiting

Address

Centre hospitalier d'enfants Albert Royer

Dakar, ,

Site Contact

Ibrahima Diagne, MD

brigitte.ranque@aphp.fr

Dakar, Senegal

Status

Recruiting

Address

Centre hospitalo-universotaire de Fann, Cardiology department

Dakar, ,

Site Contact

Bara Diop, MD

brigitte.ranque@aphp.fr

Centre national de transfusion sanguine, Dakar, Senegal

Status

Recruiting

Address

Centre national de transfusion sanguine

Dakar, ,

Site Contact

Saliou Diop, MD

brigitte.ranque@aphp.fr

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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