SyncopeNCT05538143
Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective Validation of the Canadian Syncope Risk Score
An observational study of Syncope, run by Kaiser Permanente at 5 sites in United States.
Trial summary
Among Kaiser Permanente Northern California (KPNC) health plan members, age ≥16 years, with recent syncope and presyncope undergoing emergency department (ED) management with a point-of-care clinical decision support (CDS) tool, how well does the Canadian Syncope Risk Score predict 30-day serious outcomes that were… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Comprehensive ED syncope/presyncope management tool
- How many people
- 4,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Mar 2022to 31 Dec 2024
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients presenting to KPNC emergency departments with eligibility criteria
Who may be able to join
- Age ≥16y
- Member of Kaiser Permanente Northern California (KPNC) health plan
- Presentation to the ED with an ED diagnosis of recent syncope or presyncope (<24h) without a serious etiology identified during the initial ED diagnostic assessment, that is, patients with unexplained syncope.
- Subjects who meet criteria will be identified electronically within the CDS tool in the electronic health record.
Who cannot join
- Age <16 years old
- Non-members of KPNC
- Patients with obvious witnessed seizure, prolonged loss of consciousness (>5 minutes), post-traumatic loss of consciousness, and new mental status changes
- Patients requiring hospitalization for traumatic injuries (e.g., syncope leading to motorized vehicle collision), because their outcomes may be related to trauma rather than syncope
- Patients with impaired communication capacity, e.g., intoxication, language barriers, and dementia.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Kaiser Permanente Oakland Emergency Department
Oakland, California, 94611
Kaiser Permanente Richmond Emergency Department
Richmond, California, 94801
Kaiser Permanente Roseville Emergency Department
Roseville, California, 95661
Kaiser Permanente South Sacramento Emergency Department
Sacramento, California, 95823
Kaiser Permanente Sacramento Emergency Department
Sacramento, California, 95825
About this study
Among Kaiser Permanente Northern California (KPNC) health plan members, age ≥16 years, with recent syncope and presyncope undergoing emergency department (ED) management with a point-of-care clinical decision support (CDS) tool, how well does the Canadian Syncope Risk Score predict 30-day serious outcomes that were not evident during index ED evaluation?
- Conditions
- Syncope
- Being tested
- Comprehensive ED syncope/presyncope management tool
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive ED syncope/presyncope management toolOther
This is a data-only, prospective observational cohort study to validate the performance metrics of the Canadian Syncope Risk Score in a diverse population of patients evaluated in community EDs of a U.S. integrated health care system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with arrhythmic and nonarrhythmic serious outcomes
Serious outcomes include those which are arrhythmic (arrhythmias, interventions for arrhythmia, or unknown cause of death) and nonarrhythmic (e.g., myocardial infarction, structural heart disease, pulmonary embolism, or hemorrhage)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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.
- More trials run by Kaiser PermanenteThe 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538143
- Sponsor's protocol ID
- 1721270
- Status last verified
- Mar 2024
- First submitted
- 8 Sep 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective Validation of the Canadian Syncope Risk Score
- ClinicalTrials.gov ID
- NCT05538143
- Acronym / sponsor ID
- 1721270
- Conditions
- Syncope
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 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.
Among Kaiser Permanente Northern California (KPNC) health plan members, age ≥16 years, with recent syncope and presyncope undergoing emergency department (ED) management with a point-of-care clinical decision support (CDS) tool, how well does the Canadian Syncope Risk Score predict 30-day serious outcomes that were not evident during index ED evaluation?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to KPNC emergency departments with eligibility criteria
Key inclusion criteria (4 listed)
- Age ≥16y
- Member of Kaiser Permanente Northern California (KPNC) health plan
- Presentation to the ED with an ED diagnosis of recent syncope or presyncope (<24h) without a serious etiology identified during the initial ED diagnostic assessment, that is, patients with unexplained syncope.
- Subjects who meet criteria will be identified electronically within the CDS tool in the electronic health record.
Key exclusion criteria (5 listed)
- Age <16 years old
- Non-members of KPNC
- Patients with obvious witnessed seizure, prolonged loss of consciousness (>5 minutes), post-traumatic loss of consciousness, and new mental status changes
- Patients requiring hospitalization for traumatic injuries (e.g., syncope leading to motorized vehicle collision), because their outcomes may be related to trauma rather than syncope
- Patients with impaired communication capacity, e.g., intoxication, language barriers, and dementia.
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 |
|---|---|---|
| Comprehensive ED syncope/presyncope management toolThis is a data-only, prospective observational cohort study to validate the performance metrics of the Canadian Syncope Risk Score in a diverse population of patients evaluated in community EDs of a U.S. integrated health care system. | Other | – |
Primary outcome
Number of patients with arrhythmic and nonarrhythmic serious outcomes
Time frame: 30 days
Serious outcomes include those which are arrhythmic (arrhythmias, interventions for arrhythmia, or unknown cause of death) and nonarrhythmic (e.g., myocardial infarction, structural heart disease, pulmonary embolism, or hemorrhage)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites 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 Kaiser Permanente at 5 sites in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
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?
Number of patients with arrhythmic and nonarrhythmic serious outcomes (time frame: 30 days). 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 6 Mar 2024.