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Remote Heart Monitoring for Fainting (REMOSYNCED Trial)
N/A
Recruiting
Led By Venkatesh Thiruganasambandamoorthy
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
REMOSYNCED Trial Summary
This trial is testing whether it's better to have a short or long heart monitor for people who faint.
Who is the study for?
This trial is for adults over 18 who've fainted and are at medium to high risk of heart rhythm problems, as determined by the CSRS score. They must have visited the emergency department within 24 hours and be discharged home. It's not for those hospitalized with a clear cause for fainting, had a long loss of consciousness, seizures or head trauma before fainting, or can't give details due to substance use.Check my eligibility
What is being tested?
The study tests if using Cardiophone Plus—a device that monitors heart rhythms live—for 15 days after ED discharge helps find irregular heartbeats in patients who've fainted. The goal is to see if this leads to better safety and lower healthcare costs compared to standard care with no prolonged monitoring.See study design
What are the potential side effects?
Since this trial involves non-invasive monitoring rather than medication, typical drug side effects aren't expected. However, participants may experience discomfort or skin irritation from wearing the device continuously.
REMOSYNCED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with arrhythmia that required treatment
Secondary outcome measures
Any serious outcome
Device Insertion
Number of participants with arrhythmias that did not require treatment
+4 moreREMOSYNCED Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged 24/7 live outpatient cardiac rhythm monitoringExperimental Treatment1 Intervention
Patients randomized to the intervention arm will receive 24/7 live cardiac rhythm monitoring for 15 days. If a patient is randomized to the intervention arm and was prescribed outpatient cardiac monitoring such as Holter monitor, this will be replaced by the 24/7 live monitoring and will be applied either prior or within 24 hours of discharge from the ED.
Group II: Usual careActive Control1 Intervention
Patients randomized to usual care will receive all care as prescribed by the discharging physician and there will be no study specific interventions. The current usual care varies from no outpatient monitoring to short-term Holter monitoring (24 hours to 72 hours).
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,111 Total Patients Enrolled
Venkatesh ThiruganasambandamoorthyPrincipal InvestigatorOttawa Hospital Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult who fainted and was seen at the ER within 24 hours, considered medium or high risk, and am being discharged.You were hospitalized during your first visit to the emergency room for fainting due to a serious health problem.Your level of alertness and awareness is lower than normal.You have experienced a seizure or head injury before losing consciousness, and you are not able to explain what happened (for example, due to being intoxicated).I have experienced a loss of consciousness for more than 5 minutes.
Research Study Groups:
This trial has the following groups:- Group 1: Prolonged 24/7 live outpatient cardiac rhythm monitoring
- Group 2: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for enrolment in this medical experiment?
"Indeed, the information posted on clinicaltrials.gov provides evidence that this medical trial is actively recruiting participants. The study was initially announced on July 1st 2022 and its most recent update took place in September 28th of the same year; currently 426 patients are needed at a single site."
Answered by AI
What is the approximate number of individuals participating in this experiment?
"Affirmative, clinicaltrials.gov confirms that this research study is actively searching for 426 individuals from a single site. This experiment was first posted on July 1st 2022 and has been updated as of September 28th 2022."
Answered by AI
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