REmote Cardiac MOnitoring of At-risk SYNCope Patients After Emergency Department Discharge -RCT
Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Oct 1, 2021
Trial Information
Current as of November 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how effective long-term heart monitoring is for patients who have fainting spells, known as syncope, after they leave the emergency department (ED). Often, patients who faint may have serious heart conditions that go undetected because the usual monitoring only lasts for a short time after their visit. This study aims to see if monitoring for 15 days can help identify dangerous heart rhythm problems, potentially improving patient safety and reducing healthcare costs.
To participate in the trial, you need to be an adult aged 18 or older who has experienced syncope and is considered medium to high risk based on specific criteria. If you qualify and decide to join, you’ll receive a heart monitor to wear for 15 days after your ED visit, which will help doctors track your heart rhythms. It’s important to note that some patients, especially those with more severe conditions or who fainted for obvious reasons like seizures or head trauma, will not be eligible for this study. If you think you might qualify, talk to your healthcare provider for more information.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patients (aged ≥ 18 years old) who present with syncope to any of the study EDs (within 24 hours), are classified as medium (3-5,) or high-risk (≥6) as per the CSRS and are being discharged from the ED either by the ED team or the consulting team if consulted to another service. Patients will be enrolled after written consent.
- • For the secondary objectives related to the embedded observational study, validation of the CSRS ultra-low-risk criteria and to evaluate if the CSRS can be updated to improve its accuracy, ED physicians will obtain verbal consent from patients who are lower risk (score \<3). These patients will not be enrolled in the randomized controlled trial.
- Exclusion Criteria:
- • Prolonged loss of consciousness (i.e., \> 5 minutes),
- • Glasgow Coma Scale \< 15 in patients without dementia (or a change in the mental status from baseline in those with dementia);
- • Witnessed obvious seizure, or head trauma preceding the loss of consciousness; and those who are unable to provide proper details (e.g., alcohol intoxication or other substance use).
- • Patients who are hospitalized on their index ED visit and who had an obvious underlying serious condition for the syncope identified during the index ED visit
About Ottawa Hospital Research Institute
The Ottawa Hospital Research Institute (OHRI) is a leading academic research institute dedicated to advancing health and healthcare through innovative research and evidence-based practices. Affiliated with The Ottawa Hospital and the University of Ottawa, OHRI fosters a collaborative environment that brings together clinicians, scientists, and trainees to conduct groundbreaking clinical trials and translational research. With a focus on improving patient outcomes, OHRI specializes in a wide range of fields, including cancer, cardiovascular health, and regenerative medicine. The institute is committed to ethical research practices and the dissemination of knowledge to enhance public health and inform healthcare policy.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ottawa, Ontario, Canada
Patients applied
Trial Officials
Venkatesh Thiruganasambandamoorthy
Principal Investigator
Ottawa Hospital Research Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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