Remote cardiac monitoring for patients at risk of fainting after emergency department discharge

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Whole-body bedside ultrasound in older adults after a fall

  This study tests whether doing a full-body ultrasound at the bedside changes how doctors manage older adults (65+) who come to the emergency department after a fall.

  Recruiting Kocaeli City Hospital · İzmit, Kocaeli · NCT07886164

• Do medicines that lengthen the heart's QT interval cause serious heart problems in hospitalized adults?

  This project will test whether commonly used hospital medicines that can prolong the heart's QT interval lead to serious cardiac events in adults admitted to Ontario hospitals.

  Recruiting at 2 sites St. Joseph's Healthcare Hamilton · Hamilton, Ontario and 1 other locations · NCT07374263

• AVEIR leadless pacemaker registry in the United Kingdom

  This project will follow people in the UK who receive an AVEIR leadless pacemaker to see how well the device works and how safe it is over five years.

  Recruiting Royal Brompton & Harefield NHS Foundation Trust · London, UK and 1 other locations · NCT06854484

• AI-based assessment of heart function using ECG wearable monitors

  This study tests if a new AI tool using a wearable heart monitor can accurately check heart function in people with heart failure compared to traditional heart scans.

  Recruiting at 8 sites Peerbridge Health, Inc · Orange, California and 7 other locations · NCT06699056

• 24-hour observation for patients with fainting episodes

  This study is testing if keeping patients with fainting episodes under observation for 24 hours can help doctors decide when it's safe for them to go home instead of sending them home right away.

  Recruiting Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam · NCT06472375

• Evaluating the timing of syncope and asystole during tilt table testing

  This study is testing if the timing of fainting during a tilt table test can help predict how well a pacemaker will work for people with reflex syncope.

  Recruiting Azienda Ospedaliera di Bolzano · Bolzano · NCT06356207

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.