Epidemiology of Sudden Death in Cameroon

Cardiovascular Diseases Clinical Trial

— DOUALA-SD  

Official title:

Sudden Death in Sub-Saharan Africa: Design and Protocol of The DOUALA-SD Prospective Survey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02031315
• Other study ID #: CRC-SD 2013
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2014
• Last updated: January 9, 2014
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2014
• Source: Cameroon Resuscitation Council
• Contact: Aimé BONNY, MD
• Phone: +33637975227
• Email: aimebonny[@]yahoo.fr
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health, Délégation du littoral, Douala
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240000
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Death, Sudden

Locations

Country	Name	City	State
Cameroon	Cameroon Resuscitation Council	Douala

Sponsors (2)

Lead Sponsor	Collaborator
Cameroon Resuscitation Council	ARCV

Country where clinical trial is conducted

Cameroon, 

References & Publications (2)

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. — View Citation

Arthur JT. Sudden deaths: cardiac and non-cardiac in children in Accra. West Afr J Med. 1995 Apr-Jun;14(2):108-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sudden death, either cardiac or non-cardiac origin		one year	No