Acute Coronary SyndromeFEVRIERNCT03231449
A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa
An observational study of Acute Coronary Syndrome and Heart Failure, run by Cardiologie et Développement at 20 sites in 13 countries.
Trial summary
FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan Africa. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Heart Failure, Syncope
- What is being tested?
- observation of current care
- How many people
- 5,000 participants
- Where
- 20 sitesin 13 countries
- Study dates
- 1 Feb 2017to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Each patient hospitalized in cardiology unit of participating centers during the month of February can be included.
Who may be able to join
- to be hospitalized in a cardiology department of a participating center during the month of February
Who cannot join
- refusal
Trial locations and contacts
20 sites in 13 countries.
20 sites in 13 countries
Cameroon4 sites
Hôpital Régional
Bafoussam
Douala General Hospital
Douala
Central Hospital
Yaoundé
Hôpital Général de Yaoundé
Yaoundé
Senegal3 sites
Hôpital de Fann
Dakar
Hôpital général de Grand Yoff
Dakar
El Hadj-Ibrahima Niass
Kaolack
Democratic Republic of the Congo2 sites
Clinique Ngaliema
Kinshasa
Clinique universitaire de Kinshasa
Kinshasa
Burundi1 site
Hopital militaire de Kamenge et polyclinique maison médicale
Bujumbura
About this study
FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan Africa.
Read the detailed 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.
- Conditions
- Acute Coronary Syndrome, Heart Failure, Syncope, Stroke, Pericarditis, Endocarditis
- Being tested
- observation of current care
- Keywords
- routine care, evaluation, Africa, observatory
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure, Syncope, Stroke, Pericarditis, Endocarditis, Arrhythmias, Cardiac, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of current careOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of patients in cardiology unit in sub-Saharan Africa:socio-demographic characterization
low/medium low / medium high/high
Measured: 5 years
Description of patients in cardiology unit in sub-Saharan Africa:causes of hospitalization
one answer with main reason for hospitalization
Measured: 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
Measured: 5 years
Description of patients in cardiology unit in sub-Saharan Africa: hospital examinations
blood test/ECG/Chest Xray/Echocardiography/Coronarography/Brain scan
Measured: 5 years
Description of patients in cardiology unit in sub-Saharan Africa: duration of hospitalization
number of days spent in cardiology departement
Measured: 5 years
Description of patients in cardiology unit in sub-Saharan Africa: discharge diagnosis
medical conclusion
Measured: 5 years
Secondary outcomes (3)
number of patients with heart failure
to measure the evolution of the number of patients with heart failure over 5 years
Measured: 5 years
number of patients with myocardial infarction
to measure the evolution of the number of patients with myocardial infarction over 5 years
Measured: 5 years
number of patients with atrial fibrillation
to measure the evolution of the number of patients with atrial fibrillation over 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 Feb 2017
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiologie et Développement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Jouven, Cardiologie et Développement
- Investigators
- Xavier Jouven, MD, PhD, Principal investigator, cardiologie et Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231449
- Sponsor's protocol ID
- 001
- Acronym
- FEVRIER
- Status last verified
- May 2018
- First submitted
- 21 Jul 2017
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 17671255Marijon 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.
PubMed 19667239Marijon 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.
PubMed 22405798Ranque 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.
PubMed 27030156Marijon 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.
PubMed 18297157Yusuf 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.
PubMed 25162888
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT03231449
- Acronym / sponsor ID
- FEVRIER / 001
- Conditions
- Acute Coronary Syndrome, Heart Failure, Syncope, Stroke, Pericarditis, Endocarditis
- Keywords
- routine care, evaluation, Africa, observatory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Cardiologie et DéveloppementUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan Africa.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Each patient hospitalized in cardiology unit of participating centers during the month of February can be included.
Key inclusion criteria (1 listed)
- to be hospitalized in a cardiology department of a participating center during the month of February
Key exclusion criteria (1 listed)
- refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation of current careThe 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). | Other | – |
Primary outcome
Description of patients in cardiology unit in sub-Saharan Africa:socio-demographic characterization
Time frame: 5 years
low/medium low / medium high/high
Description of patients in cardiology unit in sub-Saharan Africa:causes of hospitalization
Time frame: 5 years
one answer with main reason for hospitalization
Description of patients in cardiology unit in sub-Saharan Africa: co-morbidities
Time frame: 5 years
cardiovascular risk factors/history of cardiovascular disease/kidney disease/cancer/alcoholism/psychiatric disorder/sickle cell anemia/HIV:Hepatitis/tuberculosis/other
Description of patients in cardiology unit in sub-Saharan Africa: hospital examinations
Time frame: 5 years
blood test/ECG/Chest Xray/Echocardiography/Coronarography/Brain scan
Description of patients in cardiology unit in sub-Saharan Africa: duration of hospitalization
Time frame: 5 years
number of days spent in cardiology departement
Description of patients in cardiology unit in sub-Saharan Africa: discharge diagnosis
Time frame: 5 years
medical conclusion
3 secondary outcomes
number of patients with heart failure
Time frame: 5 years
number of patients with myocardial infarction
Time frame: 5 years
number of patients with atrial fibrillation
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Background: PubMed 17671255Marijon 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.
- Background: PubMed 19667239Marijon 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.
- Background: PubMed 22405798Marijon 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.
- Background: PubMed 27030156Ranque 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.
- Background: PubMed 18297157Marijon 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.
- Background: PubMed 25162888Yusuf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Jouven, MD, PhD principal investigator
cardiologie et Developpement
20 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Heart Failure, run by Cardiologie et Développement at 20 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Cameroon, Senegal, Côte d’Ivoire, Democratic Republic of the Congo, Benin and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of patients in cardiology unit in sub-Saharan Africa:socio-demographic characterization (time frame: 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231449, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.