CARDIOVASCULAR JOURNAL OF AFRICA • Volume 25, No 4, July/August 2014
AFRICA
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data on the prevalence and incidence of sudden cardiac death
in Africa, disease and patient characteristics, mechanisms of
cardiac arrest, as well as the survival rate in the setting of
underutilised CPR programmes.
Methods
This is a multicentre, community-based, prospective cohort
registry monitoring all cases of SCA. Several countries from all
African regions will take part in this Pan-African registry. The
specific objectives of the registry are as follows:
•
to estimate incidence of SCD in Africa
•
to estimate the prevalence of SCD among all causes of death
•
to determine factors associated with SCA in African victims
•
to study the characteristics and outcomes of SCA in Africa
•
to evaluate the extent of the use of cardio-pulmonary resus-
citation efforts.
To be eligible, subject must be a resident of the administrative
area (district) included in the study registry, and the district must
have an updated population census. Inclusion criteria are victims
of cardiac arrest, either SCD or aborted SCA. Exclusion criteria
are age ≤ 15 years, and refusal of consent (by the family).
Data collection
In each country and each city of interest, we will conduct a
pilot survey in some districts aiming to determine the number
of SCDs as well as to evaluate the adherence of the team of
each district to effectively collect data during the run-in period
of three months. The choice of these districts will be based on
eliminating areas of
<
30 000 inhabitants in the first step, and
random sampling among the remaining districts in the second.
We will calculate the approximate mean incidence rate of SCD
from all studied districts, taking into account the accuracy of
data collection in each area.
After the exclusion of districts with inaccurate data collection,
we will randomly select a few districts to constitute a sampling of
150 000 to 200 000 inhabitants in each country. All administrative
staff and community healthcare committees of selected districts
will be a key component of the research team, helping to identify
every case of death in the monitored area.
•
Every case of death will be reported by the non-medical
district staff in a specific questionnaire form (Appendix 1).
•
A nurse will collect circumstances of death to rule out the
cause of death, either natural or not.
•
A post-graduate medical student will collect socio-demo-
graphic and clinical data of every natural death victim.
•
A senior physician will study every case of suspected sudden
death, using all medical files available, as well as information
from the surroundings. Final diagnosis will be obtained by at
least two physicians. In the case of disagreement between the
experts, a third opinion will be sought. Data will be recorded
in an electronic case report form (e-CRF, Appendix 2).
•
For victims with ascertained diagnosis of SCD, informed
consent will be given to families for autopsy and eventually
for genetic analysis.
•
Biological sampling will be performed as much as is feasible
including: (1) blood sample for genetic test (DNA analysis)
of surviving individuals
<
40 years in the absence of clinical
diagnosis of cardiac disease, or in first-degree relatives of
individuals who died suddenly at a young age (
<
40 years)
and in whom autopsy was either not performed or failed to
identify the cause of death, and (2) autopsy for macroscopic
and cytological evaluation of victims.
During the time frame of the survey, all residents of districts of
interest will be monitored with regard to occurrence of death.
The non-medical staff will identify and report each case of death
to the medical staff. In addition to the deaths noted by the district
administrator’s staff and collaborators, we will pay attention to
all notices of deaths in local newspapers, radio, interrogation of
health area residents and death certificates from local medical
centres. We will propose ECG screening and a long-term follow
up for all first-degree relatives of victims under 40 years old.
The Pan-African SCD investigators will be members of the
PASCAR task force on SCD, which will be governed by the
PASCAR governing council to whom annual progress reports
will be provided. During bi-annual meetings, each research team
will discuss all cases of suspected SCD. Research teams for each
district will be composed of medical and non-medical staff. Both
will collect data of the victims.
The role of each member of the research team will as follows:
•
The district administrator and other collaborators (civil soci-
ety volunteers living in the neighbourhood constituting areas
of interest) will provide information about all deaths among
residents in the area where the survey is conducted.
•
One qualified nurse will organise collection of in-hospital
deaths. He or she will be expected to work in collaboration
with the chief of the mortuary to record out-of-hospi-
tal deaths, and with medical students who are voluntarily
involved in the project. All cases of SCD will be recorded
in the study data book. Either the nurse or the chief of the
mortuary will call the student when a suspicion of SCD needs
to be investigated within a short period of time, when family
members may provide valuable information.
•
One post-graduate fellow focusing on the topic ‘SCD epide-
miology in Africa’ for his/her thesis will participate in the
project. Apart from impromptu visits that will be dictated by
certain cases, the student will be expected to visit the mortu-
ary and the chief of the district bimonthly to evaluate the
records of all victims and determine causes of death. He or
she will be required to review the progress of the work with
the supervising physician on a monthly basis, during which
the work will be appraised.
•
The physician will be the leading coordinator in all districts
of the city where the survey is going on. Together with other
members of the research team, he will analyse all deaths and
resolve uncertainties in suspected cases of SCD.
Approval fromthe national ethics committee and local institutions
will be obtained before starting the survey in each country.
Before sampling, informed consent will be obtained from the
victim (for survivors of SCA) or his/her legal representative
and family members (for SCD) prior to inclusion in this study.
Confidentiality will be ensured in accordance with the Helsinki
Declaration.
Statistical analysis
Given the rate of incidence of SCD in the Maastricht study,
43
the need for about 70 SCAs to reach statistical significance, and
the average sample of 150 000 residents per district randomly
