Remote Heart Monitoring for Fainting

(REMOSYNCED Trial)

Overseen By Iris Nguyen, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Prolonged unconsciousness, Seizure, Head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: 15 days

580 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a device called a Cardiophone (a Mobile Cardiac Telemetry device) for 15 days can better detect irregular heart rhythms in people who have fainted and are discharged from the emergency department. Typically, patients either go home without heart monitoring or with a short-term device that tracks heartbeats for up to three days. By extending the monitoring period, the trial seeks to catch irregularities that might be missed early on, potentially improving safety and reducing healthcare costs. Suitable candidates for this trial are those who have fainted recently and are considered at medium to high risk for heart issues. As an unphased trial, it offers patients the chance to contribute to research that could enhance heart monitoring practices and improve patient safety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Cardiophone device is safe for remote heart monitoring?

Research has shown that Cardiophone, a heart monitoring device, is generally well-received by patients. It effectively tracks heart rhythms and detects irregular heartbeats, which is crucial for those at risk of heart issues like arrhythmias. No specific reports of negative side effects have emerged, indicating it is likely safe to use. Since this trial is not in its early stages, Cardiophone is already considered safe for humans. Its use in other studies and situations further supports its reliability in monitoring heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cardiophone because it offers continuous 24/7 live cardiac rhythm monitoring, which is a significant upgrade from the standard care options like Holter monitors that provide only short-term monitoring for 24 to 72 hours. This real-time, prolonged monitoring can help detect irregular heart rhythms more accurately and promptly, especially after a fainting episode. By potentially reducing the time to diagnosis and offering more comprehensive data, Cardiophone could improve patient outcomes and provide peace of mind for those with heart-related fainting issues.

What evidence suggests that the Cardiophone is effective for remote heart monitoring in syncope patients?

In this trial, participants in the intervention arm will receive mobile cardiac outpatient telemetry, a portable heart monitor, for continuous 24/7 live cardiac rhythm monitoring over 15 days. Research has shown that this type of monitoring detects fainting episodes caused by irregular heartbeats more effectively than Holter monitors, which only track heartbeats for a short period. By continuously monitoring for 15 days, more irregular heart rhythms can be identified, helping to prevent serious issues like fainting, strokes, and even heart failure. Early detection of these rhythms can improve patient safety and reduce healthcare costs. ^{1 2 4 6 7}

Who Is on the Research Team?

Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

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.

Inclusion 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.

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

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).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 24/7 live cardiac rhythm monitoring for 15 days using Cardiophone Plus

15 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Follow-up at Day 30 via telephone or email

Long-term Follow-up

Participants are followed up through data linkage with the provincial health database

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cardiophone

Trial Overview 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.

How Is the Trial Designed?

Group I: Prolonged 24/7 live outpatient cardiac rhythm monitoring Experimental Treatment 1 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 care Active Control 1 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).

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

The newly developed wireless ECG smart sensor allows for continuous monitoring of patients at risk for serious heart conditions for up to three days, providing a convenient and effective way to track heart health.

In tests, the smart sensor demonstrated better noise immunity against motion and muscle artifacts compared to traditional telemetry monitors, making it a reliable option for accurate heart rate and arrhythmia detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wireless ECG smart sensor for broad application in life threatening event detection. Welch, J., Guilak, F., Baker, S.[2020]

Mobile cardiac telemetry (MCT) has a diagnostic yield of 61%, significantly higher than the 23% yield from Event monitors and 24% from Holter monitors, indicating it is more effective in detecting arrhythmias.

Patients monitored with MCT are more likely to start antiarrhythmic drug therapy (61%) compared to those using Event (39%) or Holter monitors (43%), suggesting MCT may lead to better therapeutic management and significant cost savings in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of monitoring patients with mobile cardiac telemetry (MCT) compared with the Event or Holter monitors. Tsang, JP., Mohan, S.[2021]

In a study of 122 patients using continuous mobile cardiac outpatient telemetry (MCOT), 59% of those evaluated for presyncope/syncope received a diagnosis, highlighting MCOT's effectiveness in identifying heart rhythm issues even after previous negative evaluations.

MCOT was able to detect clinically significant arrhythmias in asymptomatic patients and facilitated medication adjustments for 33% of those monitored for antiarrhythmic therapy, demonstrating its utility in outpatient settings and reducing the need for hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of mobile cardiac outpatient telemetry for the diagnosis of palpitations, presyncope, syncope, and the assessment of therapy efficacy. Olson, JA., Fouts, AM., Padanilam, BJ., et al.[2007]

Remote monitoring for heart failure has shown promising results, with high-quality systematic reviews indicating a significant reduction in mortality risk (relative risk ranging from 0.53 to 0.88) and hospitalizations (relative risk for all-cause hospitalizations between 0.52 and 0.96, and heart failure-related hospitalizations between 0.72 and 0.79).

Despite these positive findings, the majority of systematic reviews (58%) were of poor methodological quality, highlighting the need for further research to identify which heart failure patients benefit most from remote monitoring, the best technologies to use, and the optimal duration for monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Not all systematic reviews are systematic: a meta-review of the quality of systematic reviews for non-invasive remote monitoring in heart failure. Conway, A., Inglis, SC., Chang, AM., et al.[2022]

Sudden cardiac arrest (SCA) is a significant risk for marathon runners, occurring in about 1 in 57,000 participants, particularly affecting older males during the last part of the race.

A trial using a real-time electrocardiographic tele-monitoring system showed that 3 out of 5 monitored runners had effective ECG measurements, indicating potential for early detection of SCA and improved response with automated external defibrillators (AEDs), though further improvements are needed for practical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new approach to prevent critical cardiac accidents in athletes by real-time electrocardiographic tele-monitoring system: Initial trial in full marathon. Ousaka, D., Sakano, N., Morita, M., et al.[2020]

A study involving 20 healthy marathon runners tested a new ECG sensor-embedded fabric wear (SFW) for continuous heart monitoring, achieving adequate data acquisition in 65% of participants, with issues more common in female runners and during the early race phase.

The findings suggest that while the SFW can effectively monitor heart rates, improvements in device design and software are needed to enhance data collection and better detect potential cardiac abnormalities that could lead to sudden cardiac accidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial evaluation of a novel electrocardiography sensor-embedded fabric wear during a full marathon. Ousaka, D., Hirai, K., Sakano, N., et al.[2022]

The mobile cardiac outpatient telemetry (MCOT) system proved to be safe and effective for diagnosing cardiac arrhythmias in children and adolescents, with a diagnostic rate of 61% among 54 subjects studied over an average of 24.5 days.

MCOT demonstrated a higher diagnostic yield compared to traditional monitoring methods, with 39% of subjects remaining asymptomatic during the study, and only minor skin irritation reported as a complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with novel mobile cardiac outpatient telemetry for children and adolescents with suspected arrhythmia. Saarel, EV., Doratotaj, S., Sterba, R.[2011]

The mobile cardiac outpatient telemetry (MCOT) system continuously monitors patients' electrocardiograms and automatically detects arrhythmias without requiring patient activation, enhancing patient safety and monitoring efficiency.

Data from the first 100 patients using MCOT demonstrate its capability to transmit abnormal heart rhythms instantaneously, which could lead to quicker medical responses and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First experience with a Mobile Cardiac Outpatient Telemetry (MCOT) system for the diagnosis and management of cardiac arrhythmia. Joshi, AK., Kowey, PR., Prystowsky, EN., et al.[2007]

The IMPACT Shirt is a non-invasive, easy-to-use device that continuously monitors stroke volume and ECG at home, making it a practical option for assessing heart health in patients at risk.

A proof-of-concept trial demonstrated that the stroke volume measurements from the IMPACT Shirt closely matched those from a commercial device, indicating its potential reliability for home monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The IMPACT shirt: textile integrated and portable impedance cardiography. Ulbrich, M., Mühlsteff, J., Sipilä, A., et al.[2014]

In a study involving 266 patients, the mobile cardiac outpatient telemetry system (MCOT) was able to confirm a probable arrhythmic cause of symptoms in 88% of cases, significantly outperforming the patient-activated external looping event monitor (LOOP), which had a diagnosis rate of 75%.

For patients experiencing syncope or presyncope, MCOT diagnosed 89% of cases compared to 69% for LOOP, and it detected clinically significant arrhythmias in 41% of patients, while LOOP only detected them in 15%, highlighting MCOT's superior efficacy in identifying serious heart rhythm issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diagnosis of cardiac arrhythmias: a prospective multi-center randomized study comparing mobile cardiac outpatient telemetry versus standard loop event monitoring. Rothman, SA., Laughlin, JC., Seltzer, J., et al.[2022]

Telemonitoring and remote monitoring of heart failure patients using devices that track vital signs like weight, heart rate, and blood pressure can help healthcare professionals manage care more effectively, but current methods have not shown a significant impact on patient outcomes.

Investigational devices that measure cardiac hemodynamic status through invasive pressure monitoring may improve the ability to predict heart failure events, suggesting a potential advancement in managing refractory heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring in chronic heart failure. Hasan, A., Paul, V.[2022]

The CardioMEMS device, an implantable sensor for remote monitoring of heart function, has shown promising results in preventing hospitalizations for chronic heart failure (HF) patients, particularly those who were hospitalized in the previous year and classified as New York Heart Association functional class III.

Current telemonitoring methods using traditional non-hemodynamic parameters have produced inconsistent results, highlighting the need for advanced monitoring technologies like CardioMEMS to improve patient outcomes and reduce hospital resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote monitoring of chronic heart failure patients: invasive versus non-invasive tools for optimising patient management. Veenis, JF., Brugts, JJ.[2020]

A systematic review of 11 randomized controlled trials involving 6196 heart failure patients found that remote monitoring using implantable devices did not significantly reduce all-cause mortality or hospitalizations for cardiovascular issues compared to standard care.

However, the analysis indicated that right ventricular/pulmonary pressure monitoring might help reduce heart failure hospitalizations, suggesting a potential area for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote monitoring for heart failure using implantable devices: a systematic review, meta-analysis, and meta-regression of randomized controlled trials. Hajduczok, AG., Muallem, SN., Nudy, MS., et al.[2022]

A systematic review and meta-analysis, updated with data from the GUIDE-HF trial involving 1000 heart failure patients over 12 months, found that implantable remote monitoring devices did not significantly reduce mortality or cardiovascular hospitalizations compared to standard care.

However, monitoring right ventricular or pulmonary pressure may help reduce hospitalizations due to heart failure, suggesting a potential benefit in specific aspects of patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Letter to the editor to update the article "Remote monitoring for heart failure using implantable devices: a systematic review, meta-analysis, and meta-regression of randomized controlled trials". Hajduczok, AG., Muallem, SN., Nudy, MS., et al.[2022]

Streaming electrocardiograms via mobile phones during marathons is technically feasible and allows for real-time monitoring of heart rhythms, which could help prevent sudden cardiac events.

After software improvements, the quality of data transfer during the second marathon was excellent, achieving 89% success, and all arrhythmias were correctly identified, indicating strong potential for this telemedical approach in endurance sports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocardiographic monitoring during marathon running: a proof of feasibility for a new telemedical approach. Spethmann, S., Prescher, S., Dreger, H., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3941093/

Cardiac Monitoring in Patients with Syncope - PubMed Central The implantable cardiac monitor (ICM) has become the investigative tool of choice in recurrent unexplained syncope following negative initial investigations.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05957315

Mobile Cardiac Outpatient Telemetry for Unexplained ... Wearing the mobile cardiac outpatient telemetry monitor increases the likelihood of identifying fainting episodes that were caused by abnormal heart rhythms.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3862588/

Benefits of monitoring patients with mobile cardiac ... Use of MCT instead of an Event or a Holter monitor leads to better outcomes regarding diagnostic yield, management of arrhythmia through the use of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0002870323003459

Comparative effectiveness and healthcare utilization for ... Recognition and treatment of rhythm disturbances can reduce the risk of adverse outcomes such as syncope, stroke, heart failure, sudden death, and potentially ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05066347

REmote Cardiac MOnitoring of At-risk SYNCope Patients ... The overall objective of this study is to evaluate a strategy of 15-day live cardiac rhythm monitoring versus usual care to improve the identification of an ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02786940

NCT02786940 | Remote Cardiac Monitoring of Higher-Risk ... Methods: The study will be a double-blind RCT comparing two different approaches for detecting serious arrhythmias among high-risk ED syncope patients who are ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7316129/

Wearable Devices for Ambulatory Cardiac Monitoring Ambulatory monitoring devices are enabling a new paradigm of health care by collecting and analyzing long-term data for reliable diagnostics.