Sudden Cardiac DeathC-SCANNCT03642587
Canadian Sudden Cardiac Arrest Network
An observational study of Sudden Cardiac Death and Sudden Cardiac Arrest, run by Unity Health Toronto at 6 sites in Canada.
Trial summary
The overall aim of the project is to develop a national registry to accurately measure the burden of Sudden Cardiac Arrest (SCA) among the general Canadian population. This project will create a common platform to link existing sources of information (EMS, Coroner and Administrative Databases) in order to fully… Read more about this study
- Who is it for?
- Ages 2 to 85 years
- Conditions the study is for
- Sudden Cardiac Death, Sudden Cardiac Arrest
- How many people
- 82,054 participants
- Where
- 6 sitesCanada
- Study dates
- 1 Jan 2019to 1 Jun 2023
- How long will I take part?
- 1 Year
- 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 2 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People between the ages of 2 and 85 years old with out-of-hospital cardiac arrest of no obvious cause who are attended to by paramedics who survive or die.
Who may be able to join
- All out of hospital cardiac arrest cases of "no obvious cause"
- Age between 2 and 85 years
- Attended to by paramedics, and survived or died.
Who cannot join
- Patients under the age of 2 years old or older than the age of 85 years old
- Do not resuscitate orders
- Cardiac arrests with obvious causes such as trauma, anaphylaxis, sudden upper airway occlusion, asthma, confirmed drug overdoses, homicides and suicides.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Alberta Health Services
Calgary, Alberta
Emergency Health Services
Halifax, Nova Scotia
Urgences-Sante
Montreal, Quebec
Ottawa Health Research Institute
Ottawa, Ontario
Saskatchewan Health Authority
Saskatoon, Saskatchewan
University of British Columbia
Vancouver, British Columbia
About this study
The overall aim of the project is to develop a national registry to accurately measure the burden of Sudden Cardiac Arrest (SCA) among the general Canadian population. This project will create a common platform to link existing sources of information (EMS, Coroner and Administrative Databases) in order to fully understand the causes and outcomes of SCA. This comprehensive, unique registry will inform the progress and effectiveness of all CANet SCA programs aimed at reducing SCA. Understanding the antecedents, causes and outcomes of SCA will allow for new initiatives/investigations to reduce SCA, by using targeted interventions both effectively and efficiently.
Read the detailed description
SCA is defined as an abrupt collapse with documented loss of vital signs,in a seemingly healthy individual and attributable to a cardiac cause. Estimates of SCA incidence vary widely from 53 to 153 per 100,000 persons/year. Most published studies use public reporting, death certificates or autopsy based registries to identify and classify SCA cases, but limited sources often result in missed cases. Prospective registries monitoring SCAs over time in large populations provide the most accurate estimation of incidence rates.
An ongoing challenge in developing effective strategies to decrease SCA are the varying definitions used to define SCA. Many published studies identify SCA as OHCA of "no obvious cause" (assumed to be a cardiac arrest due to an underlying primary cardiac cause); however, the two are not synonymous. Verifying that a particular OHCA is due to cardiac disease requires careful establishment, using data from multiple sources and case-by-case adjudication, which is difficult and not routinely performed. Accurate identification of true SCAs is crucial if we plan to implement interventions aimed to prevent them.
The Canadian Resuscitation Outcomes Consortium (CanROC) investigators are proposing to leverage experience gained from developing a sophisticated registry of all emergency medical service (EMS)-attended OHCA patients in Ontario and British Columbia (Resuscitation Outcomes Consortium - ROC 2005-2015). This registry has since been spread across Canada to include nine other provinces covering >15 million people in urban and rural communities. The proposed C-SCAN Registry will leverage and expand upon the CanROC infrastructure by augmenting its dataset to include detailed information both preceding and following the SCA event. Using this information to identify high-risk patients, we aim to implement targeted initiatives to decrease the incidence of SCA in Canada.
Objectives:
- To accurately identify and classify all possible SCA cases within the study area using new and existing data sources.
- To accurately measure the incidence and causes of SCA by age and sex.
- To measure the triggers and warning signs of SCA cases in relation to age, sex and etiology for the purposes of prediction and prevention.
- To confirm if the preliminary/pilot observations seen in southern Ontario are mirrored in other Canadian communities, both urban and rural, and in communities that are culturally and ethnically different from those in urban Toronto.
- Conditions
- Sudden Cardiac Death, Sudden Cardiac Arrest
- Being tested
- There is no intervention in this study.
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention in this study.Other
There is no intervention in this study.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | People between the ages of 2 and 85 years old with out of hospital cardiac arrest of no obvious cause who are attended to by paramedics who survive or die Receives: Other: There is no intervention in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SCA
Incidence of sudden cardiac arrest across Canada, by province, age and sex
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Jan 2019
- Primary completion1 Mar 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- 82,054 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Sunnybrook Health Sciences Centre, Ottawa Hospital Research Institute, University of British Columbia, Providence Health & Services, McMaster University, Queen's University, Kingston, Ontario, Institute for Clinical Evaluative Sciences, Alberta Health services, University of Saskatchewan, Dalhousie University, University of Prince Edward Island, Memorial University of Newfoundland
- Responsible party
- Sponsor
- Investigators
- Steve S Lin, MD, MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642587
- Sponsor's protocol ID
- CSCAN version 2
- Acronym
- C-SCAN
- Status last verified
- Jan 2024
- First submitted
- 20 Aug 2018
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Sudden Cardiac Arrest Network
- ClinicalTrials.gov ID
- NCT03642587
- Acronym / sponsor ID
- C-SCAN / CSCAN version 2
- Conditions
- Sudden Cardiac Death, Sudden Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82,054 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto, Sunnybrook Health Sciences Centre, Ottawa Hospital Research Institute, University of British Columbia, Providence Health & Services, McMaster University, Queen's University, Kingston, Ontario, Institute for Clinical Evaluative Sciences, Alberta Health services, University of Saskatchewan, Dalhousie University, University of Prince Edward Island, Memorial University of Newfoundland
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 22 Aug 2018 (actual)
- 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.
The overall aim of the project is to develop a national registry to accurately measure the burden of Sudden Cardiac Arrest (SCA) among the general Canadian population. This project will create a common platform to link existing sources of information (EMS, Coroner and Administrative Databases) in order to fully understand the causes and outcomes of SCA. This comprehensive, unique registry will inform the progress and effectiveness of all CANet SCA programs aimed at reducing SCA. Understanding the antecedents, causes and outcomes of SCA will allow for new initiatives/investigations to reduce SCA, by using targeted interventions both effectively and efficiently.
Detailed description
SCA is defined as an abrupt collapse with documented loss of vital signs,in a seemingly healthy individual and attributable to a cardiac cause. Estimates of SCA incidence vary widely from 53 to 153 per 100,000 persons/year. Most published studies use public reporting, death certificates or autopsy based registries to identify and classify SCA cases, but limited sources often result in missed cases. Prospective registries monitoring SCAs over time in large populations provide the most accurate estimation of incidence rates.
An ongoing challenge in developing effective strategies to decrease SCA are the varying definitions used to define SCA. Many published studies identify SCA as OHCA of "no obvious cause" (assumed to be a cardiac arrest due to an underlying primary cardiac cause); however, the two are not synonymous. Verifying that a particular OHCA is due to cardiac disease requires careful establishment, using data from multiple sources and case-by-case adjudication, which is difficult and not routinely performed. Accurate identification of true SCAs is crucial if we plan to implement interventions aimed to prevent them.
The Canadian Resuscitation Outcomes Consortium (CanROC) investigators are proposing to leverage experience gained from developing a sophisticated registry of all emergency medical service (EMS)-attended OHCA patients in Ontario and British Columbia (Resuscitation Outcomes Consortium - ROC 2005-2015). This registry has since been spread across Canada to include nine other provinces covering >15 million people in urban and rural communities. The proposed C-SCAN Registry will leverage and expand upon the CanROC infrastructure by augmenting its dataset to include detailed information both preceding and following the SCA event. Using this information to identify high-risk patients, we aim to implement targeted initiatives to decrease the incidence of SCA in Canada.
Objectives:
- To accurately identify and classify all possible SCA cases within the study area using new and existing data sources.
- To accurately measure the incidence and causes of SCA by age and sex.
- To measure the triggers and warning signs of SCA cases in relation to age, sex and etiology for the purposes of prediction and prevention.
- To confirm if the preliminary/pilot observations seen in southern Ontario are mirrored in other Canadian communities, both urban and rural, and in communities that are culturally and ethnically different from those in urban Toronto.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Other: There is no intervention in this study.People between the ages of 2 and 85 years old with out of hospital cardiac arrest of no obvious cause who are attended to by paramedics who survive or die |
Who may qualify
- Ages
- 2 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People between the ages of 2 and 85 years old with out-of-hospital cardiac arrest of no obvious cause who are attended to by paramedics who survive or die.
Key inclusion criteria (3 listed)
- All out of hospital cardiac arrest cases of "no obvious cause"
- Age between 2 and 85 years
- Attended to by paramedics, and survived or died.
Key exclusion criteria (3 listed)
- Patients under the age of 2 years old or older than the age of 85 years old
- Do not resuscitate orders
- Cardiac arrests with obvious causes such as trauma, anaphylaxis, sudden upper airway occlusion, asthma, confirmed drug overdoses, homicides and suicides.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention in this study.There is no intervention in this study. | Other | Study Population |
Primary outcome
Incidence of SCA
Time frame: 2 years
Incidence of sudden cardiac arrest across Canada, by province, age and sex
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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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.
Steve S Lin, MD, MSc principal investigator
Unity Health Toronto
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death and Sudden Cardiac Arrest, run by Unity Health Toronto at 6 sites in Canada.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of SCA (time frame: 2 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 11 Jan 2024.