NCT03231449

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
12 countries

19 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

3.8 years

First QC Date

July 21, 2017

Last Update Submit

May 24, 2018

Conditions

Keywords

routine care, evaluation, Africa, observatory

Outcome Measures

Primary Outcomes (6)

  • Description of patients in cardiology unit in sub-Saharan Africa:socio-demographic characterization

    low/medium low / medium high/high

    5 years

  • Description of patients in cardiology unit in sub-Saharan Africa:causes of hospitalization

    one answer with main reason for hospitalization

    5 years

  • 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

  • Description of patients in cardiology unit in sub-Saharan Africa: hospital examinations

    blood test/ECG/Chest Xray/Echocardiography/Coronarography/Brain scan

    5 years

  • Description of patients in cardiology unit in sub-Saharan Africa: duration of hospitalization

    number of days spent in cardiology departement

    5 years

  • Description of patients in cardiology unit in sub-Saharan Africa: discharge diagnosis

    medical conclusion

    5 years

Secondary Outcomes (3)

  • number of patients with heart failure

    5 years

  • number of patients with myocardial infarction

    5 years

  • number of patients with atrial fibrillation

    5 years

Interventions

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).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Each patient hospitalized in cardiology unit of participating centers during the month of February can be included.

You may qualify if:

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

You may not qualify if:

  • refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Centre national hospitalier et universitaire Koutoukou Maga

Cotonou, Benin

Location

Centre médical Paul IV

Ouagadougou, Burkina Faso

Location

Hopital militaire de Kamenge et polyclinique maison médicale

Bujumbura, Burundi

Location

Hôpital Régional

Bafoussam, Cameroon

Location

Douala General Hospital

Douala, Cameroon

Location

Central Hospital

Yaoundé, Cameroon

Location

Hôpital Général de Yaoundé

Yaoundé, Cameroon

Location

Institut de Cariologie d'Abidjan

Abidjan, Côte d’Ivoire

Location

CHU

Bouaké, Côte d’Ivoire

Location

Clinique Ngaliema

Kinshasa, Democratic Republic of the Congo

Location

Clinique universitaire de Kinshasa

Kinshasa, Democratic Republic of the Congo

Location

Centre Hospitalier Universitaire (CHUL)

Libreville, Gabon

Location

CHU Ignace Deen

Conakry, Guinea

Location

Institut du coeur

Maputo, Mozambique

Location

Hôpital National Lamorde

Niamey, Niger

Location

CHU

Brazzaville, Republic of the Congo

Location

Hôpital de Fann

Dakar, Senegal

Location

Hôpital général de Grand Yoff

Dakar, Senegal

Location

El Hadj-Ibrahima Niass

Kaolack, Senegal

Location

National Cardiothoracic center / Shab Teaching Hospital

Khartoum, Sudan

Location

Related Publications (6)

  • 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: 17671255BACKGROUND
  • 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: 19667239BACKGROUND
  • 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: 22405798BACKGROUND
  • 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: 27030156BACKGROUND
  • 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: 18297157BACKGROUND
  • 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: 25162888BACKGROUND

MeSH Terms

Conditions

Acute Coronary SyndromeHeart FailureSyncopeStrokePericarditisEndocarditisArrhythmias, CardiacPulmonary EmbolismVenous Thrombosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesPathologic ProcessesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisThrombosis

Study Officials

  • Xavier Jouven, MD, PhD

    cardiologie et Developpement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2017

First Posted

July 27, 2017

Study Start

February 1, 2017

Primary Completion

December 1, 2020

Study Completion

February 1, 2021

Last Updated

May 25, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations