Clinical trial NCT02031315: Epidemiology of Sudden Death in Cameroon
Official title: Sudden Death in Sub-Saharan Africa: Design and Protocol of The DOUALA-SD Prospective Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Keywords: sudden death
sudden cardiac arrest
Lead sponsor: Cameroon Resuscitation Council
Sponsor class: OTHER
Collaborators: name: ARCV
First posted: 2014-01-09
Enrollment: 240000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria: All witnessed and unwitnessed victims of unexpected natural death

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Exclusion Criteria:

* Victims living in the area of interest for a short time frame (\< 12 months)
* Absence of information helping to determine circumstances of death

Primary outcomes:
measure: Sudden death, either cardiac or non-cardiac origin
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Douala
country: Cameroon
facility: Cameroon Resuscitation Council
Study officials:
affiliation: Teaching Hospital Laquintinie, University of Douala, Cameroon
name: Aimé BONNY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arthur JT. Sudden deaths: cardiac and non-cardiac in children in Accra. West Afr J Med. 1995 Apr-Jun;14(2):108-11.
citation: Akinwusi 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.