<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03231449</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT03231449</nct_id>
  </id_info>
  <brief_title>A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa</brief_title>
  <acronym>FEVRIER</acronym>
  <official_title>A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiologie et Développement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardiologie et Développement</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan&#xD;
      Africa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FEVRIER is an observational study based on a questionnaire completed by investigators for&#xD;
      each hospitalization in cardiology unit during the month of February.The investigator is a&#xD;
      physician of the participating hospital.&#xD;
&#xD;
      FEVRIER evaluates the modalities of care management. It will take place in cardiology units&#xD;
      of hospitals of sub-Saharian countries one month per year (month of February) during 5 years.&#xD;
&#xD;
      The investigator will thoroughly complete:&#xD;
&#xD;
        -  one information form describing the hospital and the department&#xD;
&#xD;
        -  one questionnaire (2o questions) for each hospitalized patient&#xD;
&#xD;
      Patients with at least one day of hospitalization will be enrolled in the study. On the first&#xD;
      day of February, all patients already hospitalized will be enrolled and all patients&#xD;
      hospitalized in the last day of February will be followed until their discharge. thus, data&#xD;
      collection will start 1st day of investigation, during February and will continue until the&#xD;
      discharge of the last enrolled patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Description of patients in cardiology unit in sub-Saharan Africa:socio-demographic characterization</measure>
    <time_frame>5 years</time_frame>
    <description>low/medium low / medium high/high</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of patients in cardiology unit in sub-Saharan Africa:causes of hospitalization</measure>
    <time_frame>5 years</time_frame>
    <description>one answer with main reason for hospitalization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of patients in cardiology unit in sub-Saharan Africa: co-morbidities</measure>
    <time_frame>5 years</time_frame>
    <description>cardiovascular risk factors/history of cardiovascular disease/kidney disease/cancer/alcoholism/psychiatric disorder/sickle cell anemia/HIV:Hepatitis/tuberculosis/other</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of patients in cardiology unit in sub-Saharan Africa: hospital examinations</measure>
    <time_frame>5 years</time_frame>
    <description>blood test/ECG/Chest Xray/Echocardiography/Coronarography/Brain scan</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of patients in cardiology unit in sub-Saharan Africa: duration of hospitalization</measure>
    <time_frame>5 years</time_frame>
    <description>number of days spent in cardiology departement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of patients in cardiology unit in sub-Saharan Africa: discharge diagnosis</measure>
    <time_frame>5 years</time_frame>
    <description>medical conclusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of patients with heart failure</measure>
    <time_frame>5 years</time_frame>
    <description>to measure the evolution of the number of patients with heart failure over 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients with myocardial infarction</measure>
    <time_frame>5 years</time_frame>
    <description>to measure the evolution of the number of patients with myocardial infarction over 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients with atrial fibrillation</measure>
    <time_frame>5 years</time_frame>
    <description>to measure the evolution of the number of patients with atrial fibrillation over 5 years</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Heart Failure</condition>
  <condition>Syncope</condition>
  <condition>Stroke</condition>
  <condition>Pericarditis</condition>
  <condition>Endocarditis</condition>
  <condition>Conduction Abnormalities</condition>
  <condition>Rhythm; Abnormal</condition>
  <condition>Pulmonary Embolism</condition>
  <condition>Deep Vein Thrombosis</condition>
  <condition>Other Cardiovascular Conditions</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observation of current care</intervention_name>
    <description>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).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Each patient hospitalized in cardiology unit of participating centers during the month of&#xD;
        February can be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  to be hospitalized in a cardiology department of a participating center during the&#xD;
             month of February&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier Jouven, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>cardiologie et Developpement</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre national hospitalier et universitaire Koutoukou Maga</name>
      <address>
        <city>Cotonou</city>
        <country>Benin</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre médical Paul IV</name>
      <address>
        <city>Ouagadougou</city>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital militaire de Kamenge et polyclinique maison médicale</name>
      <address>
        <city>Bujumbura</city>
        <country>Burundi</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Régional</name>
      <address>
        <city>Bafoussam</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Douala General Hospital</name>
      <address>
        <city>Douala</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Hospital</name>
      <address>
        <city>Yaounde</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Général de Yaoundé</name>
      <address>
        <city>Yaounde</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Ngaliema</name>
      <address>
        <city>Kinshasa</city>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique universitaire de Kinshasa</name>
      <address>
        <city>Kinshasa</city>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Brazzaville</city>
        <country>Congo</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cariologie d'Abidjan</name>
      <address>
        <city>Abidjan</city>
        <country>Côte D'Ivoire</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Bouake</city>
        <country>Côte D'Ivoire</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire (CHUL)</name>
      <address>
        <city>Libreville</city>
        <country>Gabon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Ignace Deen</name>
      <address>
        <city>Conakry</city>
        <country>Guinea</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut du coeur</name>
      <address>
        <city>Maputo</city>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital National Lamorde</name>
      <address>
        <city>Niamey</city>
        <country>Niger</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Fann</name>
      <address>
        <city>Dakar</city>
        <country>Senegal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital général de Grand Yoff</name>
      <address>
        <city>Dakar</city>
        <country>Senegal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>El Hadj-Ibrahima Niass</name>
      <address>
        <city>Kaolac</city>
        <country>Senegal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cardiothoracic center / Shab Teaching Hospital</name>
      <address>
        <city>Khartoum</city>
        <country>Sudan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Benin</country>
    <country>Burkina Faso</country>
    <country>Burundi</country>
    <country>Cameroon</country>
    <country>Congo</country>
    <country>Congo, The Democratic Republic of the</country>
    <country>Côte D'Ivoire</country>
    <country>Gabon</country>
    <country>Guinea</country>
    <country>Mozambique</country>
    <country>Niger</country>
    <country>Senegal</country>
    <country>Sudan</country>
  </location_countries>
  <reference>
    <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. doi: 10.1056/NEJMoa065085.</citation>
    <PMID>17671255</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19667239</PMID>
  </reference>
  <reference>
    <citation>Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9.</citation>
    <PMID>22405798</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27030156</PMID>
  </reference>
  <reference>
    <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. doi: 10.2471/blt.07.046680. No abstract available.</citation>
    <PMID>18297157</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25162888</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>May 24, 2018</last_update_submitted>
  <last_update_submitted_qc>May 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardiologie et Développement</investigator_affiliation>
    <investigator_full_name>Xavier Jouven</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>routine care, evaluation, Africa, observatory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Syncope</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Endocarditis</mesh_term>
    <mesh_term>Pericarditis</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03231449
org study id: 001
nct id: NCT03231449
lead sponsor: 
collaborator: 
has dmc: No
FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan
      Africa.
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.
observational model: Cohort
time perspective: Prospective
measure: Description of patients in cardiology unit in sub-Saharan Africa:socio-demographic characterization
time frame: 5 years
description: low/medium low / medium high/high
measure: Description of patients in cardiology unit in sub-Saharan Africa:causes of hospitalization
time frame: 5 years
description: one answer with main reason for hospitalization
measure: Description of patients in cardiology unit in sub-Saharan Africa: co-morbidities
time frame: 5 years
description: cardiovascular risk factors/history of cardiovascular disease/kidney disease/cancer/alcoholism/psychiatric disorder/sickle cell anemia/HIV:Hepatitis/tuberculosis/other
measure: Description of patients in cardiology unit in sub-Saharan Africa: hospital examinations
time frame: 5 years
description: blood test/ECG/Chest Xray/Echocardiography/Coronarography/Brain scan
measure: Description of patients in cardiology unit in sub-Saharan Africa: duration of hospitalization
time frame: 5 years
description: number of days spent in cardiology departement
measure: Description of patients in cardiology unit in sub-Saharan Africa: discharge diagnosis
time frame: 5 years
description: medical conclusion
measure: number of patients with heart failure
time frame: 5 years
description: to measure the evolution of the number of patients with heart failure over 5 years
measure: number of patients with myocardial infarction
time frame: 5 years
description: to measure the evolution of the number of patients with myocardial infarction over 5 years
measure: number of patients with atrial fibrillation
time frame: 5 years
description: to measure the evolution of the number of patients with atrial fibrillation over 5 years
intervention type: Other
intervention name: observation of current care
description: 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).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Xavier Jouven, MD, PhD
role: Principal Investigator
affiliation: cardiologie et Developpement
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Benin
country: Burkina Faso
country: Burundi
country: Cameroon
country: Congo
country: Congo, The Democratic Republic of the
country: Côte D'Ivoire
country: Gabon
country: Guinea
country: Mozambique
country: Niger
country: Senegal
country: Sudan
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. doi: 10.1056/NEJMoa065085.
PMID: 17671255
citation: 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.
PMID: 19667239
citation: Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9.
PMID: 22405798
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.
PMID: 27030156
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. doi: 10.2471/blt.07.046680. No abstract available.
PMID: 18297157
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.
PMID: 25162888
responsible party type: Principal Investigator
investigator affiliation: Cardiologie et Développement
investigator full name: Xavier Jouven
investigator title: Professor
mesh term: Pulmonary Embolism
mesh term: Syncope
mesh term: Thrombosis
mesh term: Acute Coronary Syndrome
mesh term: Embolism
mesh term: Venous Thrombosis
mesh term: Endocarditis
mesh term: Pericarditis
mesh term: Arrhythmias, Cardiac
sharing ipd: No