Cardiovascular DiseasesNCT02142270
Epidemiology of Sudden Cardiac Arrest in Sub-Saharan Africa: Rationale and Design
An observational study of Cardiovascular Diseases, run by Cameroon Resuscitation Council at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 250,000 participants
- Where
- 1 siteCameroon
- Study dates
- Jan 2015to Jan 2018
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Victims of cardiac arrest, either SCD or aborted SCA
Who cannot join
- Age ≤ 15 years.
- Refusal of consent (by the family).
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Bonny
Douala, 2701
Aime Bonny, 33637975227, aimebonny@yahoo.fr
Aime Bonny, MD
About this study
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.
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Victims of cardiac arrest, either SCD or aborted SCA | Not described | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudden Cardiac Death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Cameroon Resuscitation Council
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BONNY Aimé, Cameroon Resuscitation Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142270
- Sponsor's protocol ID
- PASCAR
- Status last verified
- May 2014
- First submitted
- 10 May 2014
- Last updated
- 20 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Sudden Cardiac Arrest in Sub-Saharan Africa: Rationale and Design
- ClinicalTrials.gov ID
- NCT02142270
- Acronym / sponsor ID
- PASCAR
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250,000 participants (estimated)
- Lead sponsor
- Cameroon Resuscitation CouncilUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Victims of cardiac arrest, either SCD or aborted SCA
Key exclusion criteria (2 listed)
- Age ≤ 15 years.
- Refusal of consent (by the family).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sudden Cardiac Death
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Cameroon Resuscitation Council at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aime Bonny (33637975227, aimebonny@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sudden Cardiac Death (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.