NCT02142270

Brief Summary

Background The burden of sudden cardiac death (SCD) in Africa is unknown. Our aim is to assess the epidemiology of SCD in Africa. Methods The sub-Saharan Africa SCD study is a prospective, multicenter, community-based registry monitoring all cases of cardiac arrest occurring in victims \> 15 years old. Investigators will use the definition of established SCD if an unexpected death without obvious extracardiac cause, occurred with a rapid witnessed collapse, or if unwitnessed, occurred within 1 hour after the onset of symptoms; probable SCD if an unexpected death without obvious extracardiac cause occurred within the previous 24 hours. After approval from institutional boards, Investigators will record demographic, clinical, electrocardiographic and biological variables of SCD victims (including survivors of cardiac arrest) in several sub-Saharan African cities. All deaths occurring in residents of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). Investigators will also analyze the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient populations throughout countries. Conclusion This study will provide comprehensive, contemporary data on the epidemiology of SCD in sub-Saharan Africa and will help in the development of strategies to prevent and manage cardiac arrest in this region of the world.

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
250,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 10, 2014

Last Update Submit

May 19, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sudden Cardiac Death

    3 years

Study Arms (2)

Victims of cardiac arrest, either SCD or aborted SCA

Premature death

All residents of districts of interest will be surveyed during 3 years. premature deaths occurring in residents of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). Investigators will also analyze the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient populations throughout African countries. The arm group of the study is every resident of the district of interest

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All residents of districts of interest will be surveyed during 3 years. premature deaths occurring in residents of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). Investigators will also analyze the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient populations throughout African countries. The arm group of the study is every resident of the district of interest

You may qualify if:

  • Victims of cardiac arrest, either SCD or aborted SCA

You may not qualify if:

  • Age ≤ 15 years.
  • Refusal of consent (by the family).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bonny

Douala, 2701, Cameroon

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 10, 2014

First Posted

May 20, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2018

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations