Remote cardiac monitoring for patients at risk of fainting after emergency department discharge
REmote Cardiac MOnitoring of At-risk SYNCope Patients After Emergency Department Discharge - A Multicenter Randomized Controlled Trial: REMOSYNCED
This study is testing if a special heart monitor can help find serious heart problems in adults who faint and are at risk after leaving the emergency room.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 580 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05066347 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients who experience syncope, or fainting, and are discharged from the emergency department. It aims to assess the effectiveness of prolonged live cardiac rhythm monitoring for 15 days using the Cardiophone Plus device in identifying serious underlying heart conditions that may not be detected with standard monitoring. The study will enroll adult patients classified as medium to high risk for arrhythmias based on a specific risk score. By providing continuous monitoring, the study seeks to improve patient outcomes and risk stratification after discharge.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who present with syncope and are classified as medium to high risk for arrhythmias.
Not a fit: Patients who experience prolonged loss of consciousness, have a Glasgow Coma Scale score below 15, or have a witnessed seizure or head trauma prior to fainting may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of life-threatening heart conditions in patients who experience syncope.
How similar studies have performed: Other studies have indicated that prolonged cardiac monitoring can improve detection rates of arrhythmias, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital - Civic and General Campuses — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Venkatesh Thiruganasambandamoorthy — Ottawa Hospital Research Institute
- Study coordinator: Iris Nguyen, BSc
- Email: pnguyen@ohri.ca
- Phone: 613-798-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.