Cardiovascular DiseasesDOUALA-SDNCT02031315
Epidemiology of Sudden Death in Cameroon
An observational study of Cardiovascular Diseases, run by Cameroon Resuscitation Council at 1 site in Cameroon.
Trial summary
Background The burden of sudden death (SD) in sub-Saharan Africa is unknown. The aim is to assess the incidence, etiology and patient characteristics of SD in a sub-Saharan country. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 240,000 participants
- Where
- 1 siteCameroon
- Study dates
- Jan 2014to Dec 2016
- How long will I take part?
- 72 Months
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: First, the subject must be a permanent resident of one of 4 'health areas' included in the study. Second, each district of interest must have an updated population census.
Who may be able to join
None listed.
Who cannot join
- Victims living in the area of interest for a short time frame (< 12 months)
- Absence of information helping to determine circumstances of death
Trial locations and contacts
1 site in 1 country.
Cameroon1 site, 1 recruiting
- Recruiting
Cameroon Resuscitation Council
Douala
Robinson ATEH, MsC
Aimé BONNY, MD
About this study
Official title: Sudden Death in Sub-Saharan Africa: Design and Protocol of The DOUALA-SD Prospective Survey
Background The burden of sudden death (SD) in sub-Saharan Africa is unknown. The aim is to assess the incidence, etiology and patient characteristics of SD in a sub-Saharan country. Methods The Douala-SD study is a prospective, multicenter, community-based registry monitoring all cases of SD occurring in index areas of Douala city. Investigators will use the definition of SD as natural death occurring within 24h at the onset of symptoms. Demographic, clinical, electrocardiographic and biological variables (when available) of victims will be recorded. All deaths occurring in residents of health areas of interest will be checked for past medical history, circumstances of death, and autopsy (if possible). Conclusion This maiden Douala-SD study will provide comprehensive, contemporary data on the epidemiology of SD in a sub-Saharan African country and will help in the development of strategies to prevent and manage SD in Africa.
Read the detailed description
Two health areas were excluded for inaccurate data collection, and 2 other were randomly disqualified as investigators previously decided to conduct the survey in ≤ 4 areas. The mode of randomization aimed at includes no more than 1 health area per district. Finally, investigators retained 4 health areas representing 4 out of 6 districts of Douala. Thus, the sampling of 240,384 inhabitants will be monitored prospectively. All administrative staff and community-healthcare committee, the so-called " comité de santé" (COSA) of each health area will be a key component of the research team, helping identify every case of death in the area of concern. Every case of death will be reported by the staff of COSA in a specific questionnaire form. In addition to the deaths noted by members of each COSA, investigators will pay attention with all notices of deaths in local newspapers, radio, interrogation of health area residents, and death certificates from local medical centers.
- Conditions
- Cardiovascular Diseases
- Keywords
- sudden death, sudden cardiac arrest
- Medical subject headings
- Cardiovascular Diseases, Death, Sudden, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resident of health areas of interest | Residents of 4 health areas will be monitored for sudden unexpected death within 72 months of follow up. Circumstances and past medical conditions will be checked. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudden death, either cardiac or non-cardiac origin
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- 240,000 participants (estimated)
- Target duration
- 72 Months
Sponsor and investigators
- Lead sponsor
- Cameroon Resuscitation Council
- Sponsor type
- University, hospital or other
- Collaborators
- ARCV
- Responsible party
- Principal investigator, BONNY Aimé, Cameroon Resuscitation Council
- Investigators
- Aimé BONNY, MD, Principal investigator, Teaching Hospital Laquintinie, University of Douala, Cameroon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031315
- Sponsor's protocol ID
- CRC-SD 2013
- Acronym
- DOUALA-SD
- Status last verified
- Jan 2014
- First submitted
- 7 Jan 2014
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arthur JT. Sudden deaths: cardiac and non-cardiac in children in Accra. West Afr J Med. 1995 Apr-Jun;14(2):108-11.
PubMed 7495711Akinwusi PO, Komolafe AO, Olayemi OO, Adeomi AA. Pattern of sudden death at Ladoke Akintola University of Technology Teaching Hospital, Osogbo, South West Nigeria. Vasc Health Risk Manag. 2013;9:333-9. doi: 10.2147/VHRM.S44923. Epub 2013 Jun 24.
PubMed 23836978
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sudden Death in Sub-Saharan Africa: Design and Protocol of The DOUALA-SD Prospective Survey
- ClinicalTrials.gov ID
- NCT02031315
- Acronym / sponsor ID
- DOUALA-SD / CRC-SD 2013
- Conditions
- Cardiovascular Diseases
- Keywords
- sudden death, sudden cardiac arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240,000 participants (estimated)
- Lead sponsor
- Cameroon Resuscitation CouncilUniversity, hospital or other
- Collaborators
- ARCV
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Jan 2014 (estimated)
- 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.
Background The burden of sudden death (SD) in sub-Saharan Africa is unknown. The aim is to assess the incidence, etiology and patient characteristics of SD in a sub-Saharan country. Methods The Douala-SD study is a prospective, multicenter, community-based registry monitoring all cases of SD occurring in index areas of Douala city. Investigators will use the definition of SD as natural death occurring within 24h at the onset of symptoms. Demographic, clinical, electrocardiographic and biological variables (when available) of victims will be recorded. All deaths occurring in residents of health areas of interest will be checked for past medical history, circumstances of death, and autopsy (if possible). Conclusion This maiden Douala-SD study will provide comprehensive, contemporary data on the epidemiology of SD in a sub-Saharan African country and will help in the development of strategies to prevent and manage SD in Africa.
Detailed description
Two health areas were excluded for inaccurate data collection, and 2 other were randomly disqualified as investigators previously decided to conduct the survey in ≤ 4 areas. The mode of randomization aimed at includes no more than 1 health area per district. Finally, investigators retained 4 health areas representing 4 out of 6 districts of Douala. Thus, the sampling of 240,384 inhabitants will be monitored prospectively. All administrative staff and community-healthcare committee, the so-called " comité de santé" (COSA) of each health area will be a key component of the research team, helping identify every case of death in the area of concern. Every case of death will be reported by the staff of COSA in a specific questionnaire form. In addition to the deaths noted by members of each COSA, investigators will pay attention with all notices of deaths in local newspapers, radio, interrogation of health area residents, and death certificates from local medical centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 72 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resident of health areas of interest | – | –Residents of 4 health areas will be monitored for sudden unexpected death within 72 months of follow up. Circumstances and past medical conditions will be checked. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- First, the subject must be a permanent resident of one of 4 'health areas' included in the study. Second, each district of interest must have an updated population census.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Victims living in the area of interest for a short time frame (< 12 months)
- Absence of information helping to determine circumstances of death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sudden death, either cardiac or non-cardiac origin
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
- Background: PubMed 7495711Arthur JT. Sudden deaths: cardiac and non-cardiac in children in Accra. West Afr J Med. 1995 Apr-Jun;14(2):108-11.
- Background: PubMed 23836978Akinwusi PO, Komolafe AO, Olayemi OO, Adeomi AA. Pattern of sudden death at Ladoke Akintola University of Technology Teaching Hospital, Osogbo, South West Nigeria. Vasc Health Risk Manag. 2013;9:333-9. doi: 10.2147/VHRM.S44923. Epub 2013 Jun 24.
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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.
Aimé BONNY, MD principal investigator
Teaching Hospital Laquintinie, University of Douala, Cameroon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Cameroon Resuscitation Council at 1 site in Cameroon.
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 0 inclusion and 2 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 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. 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?
Contact Aimé BONNY, MD (+33637975227, aimebonny@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sudden death, either cardiac or non-cardiac origin (time frame: one year). 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 NCT02031315, which also lists 2 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 13 Jan 2014.