SyncopeNCT05560126
Canadian Prehospital Syncope Risk Score (Prehospital CSRS)
An observational study of Syncope, run by Venkatesh Thiruganasambandamoorthy at 1 site in Canada.
Trial summary
Background: Syncope is defined as a sudden, brief loss of consciousness (LOC) followed by a rapid complete recovery. It accounts for 160,000 emergency department (ED) visits each year in Canada. Despite this, few people are hospitalized (~15%) and even fewer will die (~1%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- How many people
- 4,875 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who access paramedic services through the 911 system will be included if they have suffered syncope, defined as a sudden transient loss of consciousness followed by spontaneous complete recovery.
Who may be able to join
- Patients who access paramedic services through the 911 system will be included if they have suffered syncope, defined as a sudden transient loss of consciousness followed by spontaneous complete recovery.
Who cannot join
- Pediatric patients (<18 years old),
- Patients who have a prolonged period of unconsciousness (>5 minutes),
- Change in mental status from baseline, witnessed seizure,
- Loss of consciousness due to head trauma (i.e., trauma was the initial event),
- or if unable to provide accurate details due to language barrier, cognitive impairment, alcohol, or drug intoxication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
Iris Nguyen, BSc, 613-798-5555 ext. 17766, pnguyen@ohri.ca
Jane Park, BHSc, 613-798-5555 ext. 19347, junpark@ohri.ca
About this study
Official title: Validation of the Canadian Prehospital Syncope Risk Score
Background: Syncope is defined as a sudden, brief loss of consciousness (LOC) followed by a rapid complete recovery. It accounts for 160,000 emergency department (ED) visits each year in Canada. Despite this, few people are hospitalized (~15%) and even fewer will die (~1%). Two-thirds of patients with syncope arrive at the ED by calling 911. There are many causes of syncope. Identifying patients at low risk for bad outcomes would allow paramedics to safely determine which patients need care in the ED from those who can remain home. The research team recently developed the Canadian Prehospital Syncope Risk Score (CPSRS) which accurately identified patients at low risk for 30-day serious outcomes.
Objective: The goal of this study is to validate the accuracy of the CPSRS in the prehospital setting or refine if needed to predict the risk of 30-day serious outcomes for patients with syncope.
Read more
Methods: The research team will enroll patients with syncope from five paramedic services across Canada (British Columbia - Vancouver and Kelowna areas only, London-Middlesex, York Region, Frontenac, and Ottawa). The research team will exclude patients <18 years old, LOC >5 minutes, changes in mental status from baseline, alcohol or drug intoxication, or language barrier. Paramedics will fill out a study data collection form with the CPSRS items and additional data should the tool need refinement. The data will be entered into a secure database and will assess patient outcomes (death and potentially life-threatening medical conditions) at 30 days. The research team will examine model accuracy using standard prediction measures and look to improve model accuracy if needed. The research team expects to enroll 4875 patients over a 1-year recruitment period based on annual call volumes.
Expected Outcomes: Once validated, the tool could reduce the number of patients transported to the hospital by identifying those at low risk. This would improve patient-oriented care, while at the same time saving valuable paramedic and ED resources.
Read the detailed description
The study will include patients from British Columbia (BC) Emergency Health Services (Vancouver and Kelowna areas only), London-Middlesex Paramedic Services - receiving hospitals: London Health Science Centre, York Region Paramedic Services - receiving hospital Markham Stouffville Hospital, Southlake Regional Health Centre, Mackenzie Health (Richmond Hill and Vaughan Hospital), Frontenac Paramedic Services - receiving hospitals: Kingston General Hospital, Hotel Dieu Hospital, and Ottawa Paramedic Services - receiving hospitals: The Ottawa Hospital (Civic and General campus), Queensway Carleton Hospital, Montfort Hospital.
Consecutive 911 patients will be screened by paramedics during their initial assessment. Patients meeting the above inclusion and exclusion criteria will be enrolled in the study. The research team will collect data for the CPSRS validation as well as additional variables for tool refinement if necessary. The additional variables were identified through literature, and experts in areas of syncope, prehospital, and emergency medicine. The research team will prospectively collect data in the prehospital setting, and through records review in both prehospital and in-hospital settings.
The research team will assess for outcome occurrence using a stepwise approach: 1) Review of prehospital records including ECG; 2) ED and inpatient hospital records during the index ED or any return ED visits including autopsy records for those who died, outpatient clinical notes and results of outpatient investigations available in the electronic medical records. 3) The research team will conduct a 30-day outcome assessment by telephone follow-up to verify that the patient is alive and has not sustained any SAE. During follow-up, The research team will ask questions regarding ED or outpatient clinic visits after the index event, any new diagnosis or procedural interventions, and if the cause for the syncope has been identified. The questions will require a yes/no answer. If the patient has difficulty comprehending the questions, the research team will assist the patient to understand the meaning of the questions. In addition to the questions for outcome assessment, the research team will ask patients their comfort with paramedics using the CPSRS to make disposition decisions. Our team has successfully used similar follow-up for outcomes in previous clinical decision rule studies. The research team will also work with Institute for Clinical Evaluative Sciences (ICES) or Population Data BC to check for deaths, return to ED, hospitalization, and device insertion for 1-year outcomes. Final determination of SAE will be completed by an independent Adjudication Committee blinded to the predictor variables comprised of three investigators (1 advanced care paramedic and 2 ED physicians).
The research team plans to complete the study over a twenty-one-month period which is highly feasible. The first three months are for study preparation, 12 months of data collection, and 3 months for data cleaning and analysis. The research team will publish and undertake end-of-grant knowledge translation (KT) activities during the last three months.
- Conditions
- Syncope
- Keywords
- Syncope, Emergency Medicine Services, Prehospital, Risk-stratification, Emergency Department
- Medical subject headings
- Syncope, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
A serious adverse event (SAE) occurring within 30 days of the 911 call
The definition of SAE is consistent with our previous syncope research studies including the CPSRS derivation and comprises of any one of the following: a) Death due to a cause of syncope or an unknown cause; b) Arrhythmia; c) Myocardial infarction; d) Identification of serious structural heart disease; e) Aortic dissection; f) Pulmonary embolism; g) Severe pulmonary artery hypertension; h) Subarachnoid hemorrhage; i) Significant hemorrhage; j) Other serious conditions such as ectopic pregnancy, pneumothorax, or sepsis that will require treatment, or any intervention used to treat a cause of syncope.
Measured: 30 days after the 911 call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies 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
- 4,875 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venkatesh Thiruganasambandamoorthy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Venkatesh Thiruganasambandamoorthy, Ottawa Hospital Research Institute
- Investigators
- Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560126
- Sponsor's protocol ID
- 4136
- Status last verified
- Mar 2025
- First submitted
- 26 Sep 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't have no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Canadian Prehospital Syncope Risk Score
- ClinicalTrials.gov ID
- NCT05560126
- Acronym / sponsor ID
- 4136
- Conditions
- Syncope
- Keywords
- Syncope, Emergency Medicine Services, Prehospital, Risk-stratification, Emergency Department
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,875 participants (estimated)
- Lead sponsor
- Venkatesh ThiruganasambandamoorthyUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 29 Sep 2022 (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.
Background: Syncope is defined as a sudden, brief loss of consciousness (LOC) followed by a rapid complete recovery. It accounts for 160,000 emergency department (ED) visits each year in Canada. Despite this, few people are hospitalized (~15%) and even fewer will die (~1%). Two-thirds of patients with syncope arrive at the ED by calling 911. There are many causes of syncope. Identifying patients at low risk for bad outcomes would allow paramedics to safely determine which patients need care in the ED from those who can remain home. The research team recently developed the Canadian Prehospital Syncope Risk Score (CPSRS) which accurately identified patients at low risk for 30-day serious outcomes.
Objective: The goal of this study is to validate the accuracy of the CPSRS in the prehospital setting or refine if needed to predict the risk of 30-day serious outcomes for patients with syncope.
Methods: The research team will enroll patients with syncope from five paramedic services across Canada (British Columbia - Vancouver and Kelowna areas only, London-Middlesex, York Region, Frontenac, and Ottawa). The research team will exclude patients <18 years old, LOC >5 minutes, changes in mental status from baseline, alcohol or drug intoxication, or language barrier. Paramedics will fill out a study data collection form with the CPSRS items and additional data should the tool need refinement. The data will be entered into a secure database and will assess patient outcomes (death and potentially life-threatening medical conditions) at 30 days. The research team will examine model accuracy using standard prediction measures and look to improve model accuracy if needed. The research team expects to enroll 4875 patients over a 1-year recruitment period based on annual call volumes.
Expected Outcomes: Once validated, the tool could reduce the number of patients transported to the hospital by identifying those at low risk. This would improve patient-oriented care, while at the same time saving valuable paramedic and ED resources.
Detailed description
The study will include patients from British Columbia (BC) Emergency Health Services (Vancouver and Kelowna areas only), London-Middlesex Paramedic Services - receiving hospitals: London Health Science Centre, York Region Paramedic Services - receiving hospital Markham Stouffville Hospital, Southlake Regional Health Centre, Mackenzie Health (Richmond Hill and Vaughan Hospital), Frontenac Paramedic Services - receiving hospitals: Kingston General Hospital, Hotel Dieu Hospital, and Ottawa Paramedic Services - receiving hospitals: The Ottawa Hospital (Civic and General campus), Queensway Carleton Hospital, Montfort Hospital.
Consecutive 911 patients will be screened by paramedics during their initial assessment. Patients meeting the above inclusion and exclusion criteria will be enrolled in the study. The research team will collect data for the CPSRS validation as well as additional variables for tool refinement if necessary. The additional variables were identified through literature, and experts in areas of syncope, prehospital, and emergency medicine. The research team will prospectively collect data in the prehospital setting, and through records review in both prehospital and in-hospital settings.
The research team will assess for outcome occurrence using a stepwise approach: 1) Review of prehospital records including ECG; 2) ED and inpatient hospital records during the index ED or any return ED visits including autopsy records for those who died, outpatient clinical notes and results of outpatient investigations available in the electronic medical records. 3) The research team will conduct a 30-day outcome assessment by telephone follow-up to verify that the patient is alive and has not sustained any SAE. During follow-up, The research team will ask questions regarding ED or outpatient clinic visits after the index event, any new diagnosis or procedural interventions, and if the cause for the syncope has been identified. The questions will require a yes/no answer. If the patient has difficulty comprehending the questions, the research team will assist the patient to understand the meaning of the questions. In addition to the questions for outcome assessment, the research team will ask patients their comfort with paramedics using the CPSRS to make disposition decisions. Our team has successfully used similar follow-up for outcomes in previous clinical decision rule studies. The research team will also work with Institute for Clinical Evaluative Sciences (ICES) or Population Data BC to check for deaths, return to ED, hospitalization, and device insertion for 1-year outcomes. Final determination of SAE will be completed by an independent Adjudication Committee blinded to the predictor variables comprised of three investigators (1 advanced care paramedic and 2 ED physicians).
The research team plans to complete the study over a twenty-one-month period which is highly feasible. The first three months are for study preparation, 12 months of data collection, and 3 months for data cleaning and analysis. The research team will publish and undertake end-of-grant knowledge translation (KT) activities during the last three months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who access paramedic services through the 911 system will be included if they have suffered syncope, defined as a sudden transient loss of consciousness followed by spontaneous complete recovery.
Key inclusion criteria (1 listed)
- Patients who access paramedic services through the 911 system will be included if they have suffered syncope, defined as a sudden transient loss of consciousness followed by spontaneous complete recovery.
Key exclusion criteria (5 listed)
- Pediatric patients (<18 years old),
- Patients who have a prolonged period of unconsciousness (>5 minutes),
- Change in mental status from baseline, witnessed seizure,
- Loss of consciousness due to head trauma (i.e., trauma was the initial event),
- or if unable to provide accurate details due to language barrier, cognitive impairment, alcohol, or drug intoxication.
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
A serious adverse event (SAE) occurring within 30 days of the 911 call
Time frame: 30 days after the 911 call
The definition of SAE is consistent with our previous syncope research studies including the CPSRS derivation and comprises of any one of the following: a) Death due to a cause of syncope or an unknown cause; b) Arrhythmia; c) Myocardial infarction; d) Identification of serious structural heart disease; e) Aortic dissection; f) Pulmonary embolism; g) Severe pulmonary artery hypertension; h) Subarachnoid hemorrhage; i) Significant hemorrhage; j) Other serious conditions such as ectopic pregnancy, pneumothorax, or sepsis that will require treatment, or any intervention used to treat a cause of syncope.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No. We don't have no plan to share IPD
Related trials for Syncope
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
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.
Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc principal investigator
Ottawa Hospital Research Institute
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 Syncope, run by Venkatesh Thiruganasambandamoorthy at 1 site 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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 31 Jul 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Nguyen, BSc (613-798-5555 ext. 17766, pnguyen@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A serious adverse event (SAE) occurring within 30 days of the 911 call (time frame: 30 days after the 911 call). 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 31 Jul 2025.