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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03231449
Other study ID # 001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date February 2021

Study information

Verified date May 2018
Source Cardiologie et Développement
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan Africa.


Description:

FEVRIER is an observational study based on a questionnaire completed by investigators for each hospitalization in cardiology unit during the month of February.The investigator is a physician of the participating hospital.

FEVRIER evaluates the modalities of care management. It will take place in cardiology units of hospitals of sub-Saharian countries one month per year (month of February) during 5 years.

The investigator will thoroughly complete:

- one information form describing the hospital and the department

- one questionnaire (2o questions) for each hospitalized patient

Patients with at least one day of hospitalization will be enrolled in the study. On the first day of February, all patients already hospitalized will be enrolled and all patients hospitalized in the last day of February will be followed until their discharge. thus, data collection will start 1st day of investigation, during February and will continue until the discharge of the last enrolled patient.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5000
Est. completion date February 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- to be hospitalized in a cardiology department of a participating center during the month of February

Exclusion Criteria:

- refusal

Study Design


Intervention

Other:
observation of current care
The study FEVRIER (survey of hospitalizations in cardiology units in sub-Saharan Africa) aims to establish a description of sub-Saharan standard of care, in order to get a cross sectional analysis (globally and per country) and a longitudinal analysis (evolution during 5 years).

Locations

Country Name City State
Benin Centre national hospitalier et universitaire Koutoukou Maga Cotonou
Burkina Faso Centre médical Paul IV Ouagadougou
Burundi Hopital militaire de Kamenge et polyclinique maison médicale Bujumbura
Cameroon Hôpital Régional Bafoussam
Cameroon Douala General Hospital Douala
Cameroon Central Hospital Yaounde
Cameroon Hôpital Général de Yaoundé Yaounde
Congo CHU Brazzaville
Congo, The Democratic Republic of the Clinique Ngaliema Kinshasa
Congo, The Democratic Republic of the Clinique universitaire de Kinshasa Kinshasa
Côte D'Ivoire Institut de Cariologie d'Abidjan Abidjan
Côte D'Ivoire CHU Bouake
Gabon Centre Hospitalier Universitaire (CHUL) Libreville
Guinea CHU Ignace Deen Conakry
Mozambique Institut du coeur Maputo
Niger Hôpital National Lamorde Niamey
Senegal Hôpital de Fann Dakar
Senegal Hôpital général de Grand Yoff Dakar
Senegal El Hadj-Ibrahima Niass Kaolac
Sudan National Cardiothoracic center / Shab Teaching Hospital Khartoum

Sponsors (2)

Lead Sponsor Collaborator
Cardiologie et Développement Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

Benin,  Burkina Faso,  Burundi,  Cameroon,  Congo,  Congo, The Democratic Republic of the,  Côte D'Ivoire,  Gabon,  Guinea,  Mozambique,  Niger,  Senegal,  Sudan, 

References & Publications (6)

Marijon E, Celermajer DS, Tafflet M, El-Haou S, Jani DN, Ferreira B, Mocumbi AO, Paquet C, Sidi D, Jouven X. Rheumatic heart disease screening by echocardiography: the inadequacy of World Health Organization criteria for optimizing the diagnosis of subclinical disease. Circulation. 2009 Aug 25;120(8):663-8. doi: 10.1161/CIRCULATIONAHA.109.849190. Epub 2009 Aug 10. — View Citation

Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-64. doi: 10.1016/S0140-6736(11)61171-9. Review. — View Citation

Marijon E, Ou P, Celermajer DS, Ferreira B, Mocumbi AO, Jani D, Paquet C, Jacob S, Sidi D, Jouven X. Prevalence of rheumatic heart disease detected by echocardiographic screening. N Engl J Med. 2007 Aug 2;357(5):470-6. — View Citation

Marijon E, Ou P, Celermajer DS, Ferreira B, Mocumbi AO, Sidi D, Jouven X. Echocardiographic screening for rheumatic heart disease. Bull World Health Organ. 2008 Feb;86(2):84. — View Citation

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. — View Citation

Yusuf S, Rangarajan S, Teo K, Islam S, Li W, Liu L, Bo J, Lou Q, Lu F, Liu T, Yu L, Zhang S, Mony P, Swaminathan S, Mohan V, Gupta R, Kumar R, Vijayakumar K, Lear S, Anand S, Wielgosz A, Diaz R, Avezum A, Lopez-Jaramillo P, Lanas F, Yusoff K, Ismail N, Iqbal R, Rahman O, Rosengren A, Yusufali A, Kelishadi R, Kruger A, Puoane T, Szuba A, Chifamba J, Oguz A, McQueen M, McKee M, Dagenais G; PURE Investigators. Cardiovascular risk and events in 17 low-, middle-, and high-income countries. N Engl J Med. 2014 Aug 28;371(9):818-27. doi: 10.1056/NEJMoa1311890. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Description of patients in cardiology unit in sub-Saharan Africa:socio-demographic characterization low/medium low / medium high/high 5 years
Primary Description of patients in cardiology unit in sub-Saharan Africa:causes of hospitalization one answer with main reason for hospitalization 5 years
Primary Description of patients in cardiology unit in sub-Saharan Africa: co-morbidities cardiovascular risk factors/history of cardiovascular disease/kidney disease/cancer/alcoholism/psychiatric disorder/sickle cell anemia/HIV:Hepatitis/tuberculosis/other 5 years
Primary Description of patients in cardiology unit in sub-Saharan Africa: hospital examinations blood test/ECG/Chest Xray/Echocardiography/Coronarography/Brain scan 5 years
Primary Description of patients in cardiology unit in sub-Saharan Africa: duration of hospitalization number of days spent in cardiology departement 5 years
Primary Description of patients in cardiology unit in sub-Saharan Africa: discharge diagnosis medical conclusion 5 years
Secondary number of patients with heart failure to measure the evolution of the number of patients with heart failure over 5 years 5 years
Secondary number of patients with myocardial infarction to measure the evolution of the number of patients with myocardial infarction over 5 years 5 years
Secondary number of patients with atrial fibrillation to measure the evolution of the number of patients with atrial fibrillation over 5 years 5 years
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