Epidemiology of Sudden Death in Cameroon (DOUALA-SD)

January 9, 2014 updated by: BONNY Aimé, Cameroon Resuscitation Council

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

240000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Cameroon
      • Douala, Cameroon
        • Recruiting
        • Cameroon Resuscitation Council
        • Sub-Investigator:
          • Robinson ATEH, MsC
        • Principal Investigator:
          • Aime Bonny, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sudden death, either cardiac or non-cardiac origin
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cameroon Resuscitation Council

Collaborators

ARCV

Investigators

  • Principal Investigator: Aimé BONNY, MD, Teaching Hospital Laquintinie, University of Douala, Cameroon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC-SD 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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