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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05538143
Enrollment
4000
Registered
2022-09-13
Start date
2022-03-01
Completion date
2024-12-31
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope

Brief 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?

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.

Sponsors

Kaiser Permanente
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with arrhythmic and nonarrhythmic serious outcomes30 daysSerious 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026