ClinicalTrials.gg
Enrolling by invitationNCT05538143Updated Mar 6, 2024

Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective Validation of the Canadian Syncope Risk Score

An observational study in Syncope, sponsored by Kaiser Permanente. Enrolling by invitation at 5 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Kaiser Permanente · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
16 Years and older
Sex
All
01

Study 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 not evident during index ED evaluation?

02

Conditions studied

  • Syncope

Browse trials for

03

In context

Syncope

201 studies on the registry are indexed under Syncope; 36 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 250 across 84 observational studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients presenting to KPNC emergency departments with eligibility criteria

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Patient registry
No

Interventions

  • OtherComprehensive ED syncope/presyncope management tool

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 30 days

07

Study locations

5 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05538143
Lead sponsor
Kaiser Permanente
Responsible party
Sponsor
First posted
Sep 13, 2022
Start date
Mar 1, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion