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Clinical Trials in Canada / NCT04790058
Active, not recruiting Observational

CSRS Implementation - A Pilot Study

NCT04790058 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2021-08-20
Last updated
2025-03-24

Condition(s) studied

Syncope

Investigational drug(s) / intervention(s)

Knowledge translation of the CSRS practice recommendations

Knowledge translation of the CSRS practice recommendations: The intervention is knowledge translation of the CSRS practice recommendations; the application of the practice recommendations will occur during the patient's ED visit and patients who are eligible for 15-day cardiac rhythm monitoring will have Holter monitor applied at the time of ED discharge. For the secondary objective to validate the accuracy of the ultra-low risk criteria of CSRS and assess for potential improvements in the practice recommendations and the prediction models we will request verbal consent during the index ED visit for addition of cardiac biomarker measurements \[troponin and NT-proBNP\] for patients who did not have such measurements performed as part of routine clinical care, and a 30-day telephone follow-up for serious outcome assessment. Patients who do not consent will be excluded from these portions of the study but included in the health resource utilization and generic patient safety outcome assessment objectives.

Study summary

Syncope is a common reason for emergency department (ED) presentation. While often benign, some patients have serious and life-threatening underlying causes, both cardiac and non-cardiac, which may or may not be apparent at the time of the initial ED assessment. Identifying which patients will benefit from further investigation, ongoing monitoring and/or hospital admission is essential to reduce both adverse outcomes and the high costs. Our group has spent over a decade developing the evidence base for a risk stratification tool directed at optimizing the accuracy of ED decisions: the Canadian Syncope Risk Score (CSRS). This tool is now ready for the final phase of its introduction into clinical practice, namely a robust, multicentre implementation trial of the CSRS based practice recommendations to demonstrate its real-world effectiveness. Prior to the launch of the large-scale implementation trial, a pilot study to assess primarily the feasibility and secondarily the effectiveness is needed.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
1. Physician: physicians involved in ED syncope care 2. Patients: * Inclusion Criteria: adult (aged \> 18 years) patients who present within 24 hours of syncope * Exclusion Criteria: * non-syncope (prolonged LOC \>5 minutes, change in the mental status from baseline, patients with witnessed obvious seizure, or head trauma preceding the LOC), * those unable to provide proper details - e.g., intoxication, and those with significant trauma requiring admission as per international consensus. * patients who had a serious underlying condition identified during the index ED evaluation * hospitalization for a reason other than syncope work-up (i.e. unable to cope at home).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Queensway-Carleton hospital Ottawa Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04790058 on ClinicalTrials.gov ↗ ← All trials in Canada