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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| University of Paris 5 - Rene Descartes | OTHER |
| laboratory of excellence GR-Ex | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sickle cell patients |
| ||
| control patients |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: glomerulopathy | urinary albumin/creatinin ratio (mg/g) | 10 years |
| Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: cardiopathy | left ventricular ejection fraction < 60 % | 10 years |
| Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: pulmonary hypertension | tricuspid regurgitation jet velocity (m/s) | 10 years |
| Prevalence and incidence and the 10 year-incidence of the main SCD-related vascular complications in different phenotypes of SCD: retinopathy | retinal examination | 10 years |
| Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:stroke | clinical diagnosis | 10 years |
| Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:osteonecrosis | standard radiography | 10 years |
| Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: leg ulcers | clinical diagnosis | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Potential biological risk marker measured at baseline and follow up visits: carotid-femoral pulse wave velocity | measured by Pulsepen, m/s) | 10 years |
| Potential biological risk marker measured at baseline and follow up visits: complete blood count |
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Inclusion Criteria:
Exclusion Criteria:
unstable clinical status such as:
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Children and adult patients with the sickle cell disease living in subSaharan Africa
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brigitte Ranque, MD PhD | Contact | brigitte.ranque@aphp.fr | ||
| Louise Boyer-Chatenet, MS | Contact | +33156093656 | louise.boyer-chatenet-ext@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Xavier Jouven, MD PhD | Cardiologie et Developpement | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital of Yaounde | Recruiting | Yaoundé | Cameroon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17084951 | Background | Kato GJ, Gladwin MT, Steinberg MH. Deconstructing sickle cell disease: reappraisal of the role of hemolysis in the development of clinical subphenotypes. Blood Rev. 2007 Jan;21(1):37-47. doi: 10.1016/j.blre.2006.07.001. Epub 2006 Nov 7. | |
| 21264896 | Background | Hebbel RP. Reconstructing sickle cell disease: a data-based analysis of the "hyperhemolysis paradigm" for pulmonary hypertension from the perspective of evidence-based medicine. Am J Hematol. 2011 Feb;86(2):123-54. doi: 10.1002/ajh.21952. |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D014652 | Vascular Diseases |
| D007674 | Kidney Diseases |
| D006976 | Hypertension, Pulmonary |
| D006331 | Heart Diseases |
| D006461 | Hemolysis |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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whole blood plasma saliva urines
| Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: priapism | clinical diagnosis | 10 years |
| 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 |
| Potential biological risk marker measured at baseline and follow up visits: neutrophil extracellular traps | 10 years |
| Centre mère et enfant / fondation Chantal Biya | Recruiting | Yaoundé | Cameroon |
|
| Centre Pasteur du Cameroun | Recruiting | Yaoundé | Cameroon |
|
| Pediatrics unit, Centre Hospitalier d'Essos | Recruiting | Yaoundé | Cameroon |
|
| Hematology Unit, CHU Yopougon | Recruiting | Abidjan | Côte d’Ivoire |
|
| Institut de cardiologie | Active, not recruiting | Abidjan | Côte d’Ivoire |
| Centre hospitalier Monkole | Recruiting | Kinshasa | Democratic Republic of the Congo |
|
| CIRMF | Completed | Libreville | Gabon |
| Cardiology Unit, Centre gyneco-obstretrique | Active, not recruiting | Bamako | Mali |
| Centre de Recherche et de Lutte contre la Drepanocytose | Recruiting | Bamako | Mali |
|
| Centre hospitalier d'enfants Albert Royer | Recruiting | Dakar | Senegal |
|
| Centre hospitalo-universotaire de Fann, Cardiology department | Recruiting | Dakar | Senegal |
|
| Centre national de transfusion sanguine | Recruiting | Dakar | Senegal |
|
| 22983573 | Background | Nouraie M, Lee JS, Zhang Y, Kanias T, Zhao X, Xiong Z, Oriss TB, Zeng Q, Kato GJ, Gibbs JS, Hildesheim ME, Sachdev V, Barst RJ, Machado RF, Hassell KL, Little JA, Schraufnagel DE, Krishnamurti L, Novelli E, Girgis RE, Morris CR, Rosenzweig EB, Badesch DB, Lanzkron S, Castro OL, Goldsmith JC, Gordeuk VR, Gladwin MT; Walk-PHASST Investigators and Patients. The relationship between the severity of hemolysis, clinical manifestations and risk of death in 415 patients with sickle cell anemia in the US and Europe. Haematologica. 2013 Mar;98(3):464-72. doi: 10.3324/haematol.2012.068965. Epub 2012 Sep 14. |
| 20884713 | Background | Gordeuk VR, Minniti CP, Nouraie M, Campbell AD, Rana SR, Luchtman-Jones L, Sable C, Dham N, Ensing G, Prchal JT, Kato GJ, Gladwin MT, Castro OL. Elevated tricuspid regurgitation velocity and decline in exercise capacity over 22 months of follow up in children and adolescents with sickle cell anemia. Haematologica. 2011 Jan;96(1):33-40. doi: 10.3324/haematol.2010.030767. Epub 2010 Sep 30. |
| 20833087 | Background | Maier-Redelsperger M, Levy P, Lionnet F, Stankovic K, Haymann JP, Lefevre G, Avellino V, Perol JP, Girot R, Elion J. Strong association between a new marker of hemolysis and glomerulopathy in sickle cell anemia. Blood Cells Mol Dis. 2010 Dec 15;45(4):289-92. doi: 10.1016/j.bcmd.2010.08.001. Epub 2010 Sep 15. |
| 18461136 | Background | Taylor JG 6th, Nolan VG, Mendelsohn L, Kato GJ, Gladwin MT, Steinberg MH. Chronic hyper-hemolysis in sickle cell anemia: association of vascular complications and mortality with less frequent vasoocclusive pain. PLoS One. 2008 May 7;3(5):e2095. doi: 10.1371/journal.pone.0002095. |
| 14985486 | Background | Gladwin MT, Sachdev V, Jison ML, Shizukuda Y, Plehn JF, Minter K, Brown B, Coles WA, Nichols JS, Ernst I, Hunter LA, Blackwelder WC, Schechter AN, Rodgers GP, Castro O, Ognibene FP. Pulmonary hypertension as a risk factor for death in patients with sickle cell disease. N Engl J Med. 2004 Feb 26;350(9):886-95. doi: 10.1056/NEJMoa035477. |
| 16291595 | Background | Kato GJ, McGowan V, Machado RF, Little JA, Taylor J 6th, Morris CR, Nichols JS, Wang X, Poljakovic M, Morris SM Jr, Gladwin MT. Lactate dehydrogenase as a biomarker of hemolysis-associated nitric oxide resistance, priapism, leg ulceration, pulmonary hypertension, and death in patients with sickle cell disease. Blood. 2006 Mar 15;107(6):2279-85. doi: 10.1182/blood-2005-06-2373. Epub 2005 Nov 15. |
| 24223994 | Background | Connes P, Lamarre Y, Hardy-Dessources MD, Lemonne N, Waltz X, Mougenel D, Mukisi-Mukaza M, Lalanne-Mistrih ML, Tarer V, Tressieres B, Etienne-Julan M, Romana M. Decreased hematocrit-to-viscosity ratio and increased lactate dehydrogenase level in patients with sickle cell anemia and recurrent leg ulcers. PLoS One. 2013 Nov 4;8(11):e79680. doi: 10.1371/journal.pone.0079680. eCollection 2013. |
| 15985542 | Background | Nolan VG, Wyszynski DF, Farrer LA, Steinberg MH. Hemolysis-associated priapism in sickle cell disease. Blood. 2005 Nov 1;106(9):3264-7. doi: 10.1182/blood-2005-04-1594. Epub 2005 Jun 28. |
| 16755569 | Background | Kato GJ, Hsieh M, Machado R, Taylor J 6th, Little J, Butman JA, Lehky T, Tisdale J, Gladwin MT. Cerebrovascular disease associated with sickle cell pulmonary hypertension. Am J Hematol. 2006 Jul;81(7):503-10. doi: 10.1002/ajh.20642. |
| 22641398 | Background | Steinberg MH, Sebastiani P. Genetic modifiers of sickle cell disease. Am J Hematol. 2012 Aug;87(8):795-803. doi: 10.1002/ajh.23232. Epub 2012 May 28. |
| 27582423 | Result | Ranque B, Menet A, Boutouyrie P, Diop IB, Kingue S, Diarra M, N'Guetta R, Diallo D, Diop S, Diagne I, Sanogo I, Tolo A, Chelo D, Wamba G, Gonzalez JP, Abough'elie C, Diakite CO, Traore Y, Legueun G, Deme-Ly I, Faye BF, Seck M, Kouakou B, Kamara I, Le Jeune S, Jouven X. Arterial Stiffness Impairment in Sickle Cell Disease Associated With Chronic Vascular Complications: The Multinational African CADRE Study. Circulation. 2016 Sep 27;134(13):923-33. doi: 10.1161/CIRCULATIONAHA.115.021015. Epub 2016 Aug 31. |
| 27030156 | Result | Ranque B, Menet A, Diop IB, Thiam MM, Diallo D, Diop S, Diagne I, Sanogo I, Kingue S, Chelo D, Wamba G, Diarra M, Anzouan JB, N'Guetta R, Diakite CO, Traore Y, Legueun G, Deme-Ly I, Belinga S, Boidy K, Kamara I, Tharaux PL, Jouven X. Early renal damage in patients with sickle cell disease in sub-Saharan Africa: a multinational, prospective, cross-sectional study. Lancet Haematol. 2014 Nov;1(2):e64-73. doi: 10.1016/S2352-3026(14)00007-6. Epub 2014 Oct 28. |
| 37583261 | Derived | Ranque B, Diaw M, Dembele AK, Lapoumeroulie C, Offredo L, Tessougue O, Gueye SM, Diallo D, Diop S, Colin-Aronovicz Y, Jouven X, Blanc-Brude O, Tharaux PL, Le Jeune S, Connes P, Romana M, Le Van Kim C. Association of haemolysis markers, blood viscosity and microcirculation function with organ damage in sickle cell disease in sub-Saharan Africa (the BIOCADRE study). Br J Haematol. 2023 Oct;203(2):319-326. doi: 10.1111/bjh.19006. Epub 2023 Aug 15. |
| 33249569 | Derived | Dembele AK, Lapoumeroulie C, Diaw M, Tessougue O, Offredo L, Diallo DA, Diop S, Elion J, Colin-Aronovicz Y, Tharaux PL, Jouven X, Romana M, Ranque B, Le Van Kim C. Cell-derived microparticles and sickle cell disease chronic vasculopathy in sub-Saharan Africa: A multinational study. Br J Haematol. 2021 Feb;192(3):634-642. doi: 10.1111/bjh.17242. Epub 2020 Nov 29. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |