NCT02031315

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

January 7, 2014

Last Update Submit

January 9, 2014

Conditions

Keywords

sudden deathsudden cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • Sudden death, either cardiac or non-cardiac origin

    one year

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cameroon Resuscitation Council

Douala, Cameroon

RECRUITING

Related Publications (2)

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

    PMID: 7495711BACKGROUND
  • 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.

    PMID: 23836978BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesDeath, SuddenDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsHeart ArrestHeart Diseases

Study Officials

  • Aimé BONNY, MD

    Teaching Hospital Laquintinie, University of Douala, Cameroon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimé BONNY, MD

CONTACT

Robinson ATEH, MsC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
72 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief manager

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 9, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2016

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations