Continuous Cardiac Monitoring for Heart Arrhythmia

(CARING Trial)

Recruiting at 1 trial location

Overseen By Joshua D Mitchell, M.D., FACC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Arsenic trioxide, Capecitabine, Ribociclib

Disqualifiers: Younger than 18, 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: 5

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for monitoring heart rhythms in individuals taking certain cancer drugs that may affect the heart. The study compares a continuous patch monitor, called BodyGuardian Heart, with regular heart tests like ECGs. Individuals with acute promyelocytic leukemia or certain solid tumors who are beginning specific cancer treatments may be suitable candidates. Participants must not have allergies to adhesive patches and should be willing to sign a consent form. As an unphased trial, this study allows participants to contribute to innovative monitoring techniques that could enhance heart health management during cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves patients starting specific cancer treatments, you may need to discuss your current medications with the trial team.

What prior data suggests that the BodyGuardian Heart is safe for continuous cardiac monitoring?

Research has shown that the BodyGuardian Heart monitor is safe and easy to use. It effectively tracks heart activity continuously. Studies have found that the BodyGuardian system matches the performance of other heart monitors, confirming its safety and effectiveness.

The device is comfortable and waterproof, allowing constant wear without concern. It tracks heart rhythms and sends information directly to doctors, enabling them to monitor heart issues closely without causing discomfort.

Overall, the BodyGuardian Heart monitor has proven reliable and safe in various situations, making it an effective tool for monitoring heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BodyGuardian Heart monitoring system because it offers a continuous and non-invasive way to monitor heart arrhythmias. Unlike traditional methods that might require patients to wear cumbersome devices or visit a clinic for periodic checks, this system is a wearable patch that continuously tracks heart activity. It allows for real-time monitoring and instant analysis, potentially catching irregularities earlier than other methods. This could lead to more timely interventions and better overall management of heart arrhythmias.

What evidence suggests that the BodyGuardian Heart is effective for monitoring heart arrhythmia?

Research has shown that the BodyGuardian Heart monitor, used by participants in this trial, effectively tracks heart rhythms continuously. It detects changes in heart rate during exercise, which is crucial for identifying irregular heartbeats. Studies indicate that this device provides real-time information on heart activity, aiding in the early detection of potential heart problems. It matches the reliability of standard ECGs, making it a strong choice for ongoing heart monitoring. This evidence supports its use in managing heart conditions caused by certain medications. ^{1 3 4 5 6}

Who Is on the Research Team?

Joshua D Mitchell, M.D., FACC

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with acute promyelocytic leukemia starting arsenic trioxide treatment, or those with solid tumors beginning capecitabine. Participants must not be allergic to adhesive patches and should be able to understand and sign a consent form.

Inclusion Criteria

I have acute promyelocytic leukemia and am starting treatment with arsenic trioxide.

No allergy to adhesive patches

I have a solid tumor and am starting treatment with capecitabine.

Exclusion Criteria

Allergy to adhesive patches

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care treatment with either arsenic trioxide, ribociclib, or capecitabine, and have continuous patch monitor system applied with at least 5 ECGs for comparison during the first 30 days

4 weeks

Continuous monitoring with at least 5 ECGs

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BodyGuardian Heart

Trial Overview The study is testing the BodyGuardian Mini Plus, a continuous patch monitoring system for cardiac arrhythmias, against standard ECGs in patients taking drugs that may affect the heart.

How Is the Trial Designed?

Group I: Continuous patch monitoring system Experimental Treatment 1 Intervention

-Participants will receive standard of care treatment with either arsenic trioxide, ribociclib, or capecitabine. They will have continuous patch monitor system (BodyGuardian Mini Plus) applied on or prior to the first day of therapy and will receive at least 5 ECGs for comparison during the first 30 days of treatment.

BodyGuardian Heart is already approved in United States for the following indications:

Approved in United States as BodyGuardian Heart for:

• Detection and monitoring of non-lethal cardiac arrhythmias for ambulatory patients

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Smartphone-based ECG monitors empower patients to take an active role in their heart health by allowing them to capture their own ECG readings anytime, which represents a significant shift from traditional monitoring methods.

Remote monitoring of cardiac implantable electronic devices (CIEDs) is now recommended as the preferred follow-up method, as it has been shown to reduce hospital visits, admissions, and even mortality, aligning with the goals of a value-based healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Based Electrocardiographic and Cardiac Implantable Electronic Device Monitoring. Mittal, S.[2022]

Remote monitoring of implantable cardioverter-defibrillators in a study of 176 patients over 12 months proved to be effective, allowing for timely detection of arrhythmias and device malfunctions without the need for frequent in-person visits.

Patients reported an increased sense of safety and preferred a combination of remote and outpatient visits, highlighting the patient-friendly nature of remote monitoring as a viable healthcare model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspective and safety of remote monitoring of implantable cardioverter-defibrillators in the Polish Nationwide Multicenter Registry: the Medtronic CareLink network evaluation. Maciąg, A., Mitkowski, P., Mazurek, M., et al.[2021]

Ultra-portable ECG patch monitors are being developed to improve the diagnostic yield of long-term cardiac monitoring, offering a more convenient and cost-effective alternative to traditional Holter monitors.

These patch devices, designed for long-term use, enable real-world monitoring of cardiac rhythms and may lead to better patient acceptance and the potential for new diagnostic algorithms in arrhythmia evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ECG patch monitors for assessment of cardiac rhythm abnormalities. Lobodzinski, SS.[2022]

Wearable and handheld devices that use photoplethysmography and electrocardiograms offer a promising alternative for remote screening and diagnosis of cardiac arrhythmias, improving accessibility and potentially increasing diagnostic yield for episodic arrhythmias.

Despite their advantages, there is still limited data on the accuracy and clinical utility of these devices, necessitating further research before they can be routinely integrated into clinical practice for managing arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Contemporary Wearable and Handheld Devices in the Diagnosis and Management of Cardiac Arrhythmias. Garikapati, K., Turnbull, S., Bennett, RG., et al.[2022]

A new real-time remote monitoring platform for cardiac arrhythmias allows continuous tracking of high-risk patients, improving the accuracy of diagnosing conditions like ventricular tachycardia.

This system enables patients to maintain a normal lifestyle while being monitored by a wireless ECG sensor, with immediate alerts sent to cardiologists for timely intervention, showing results comparable to traditional telemetry systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote continuous cardiac arrhythmias detection and monitoring. Zhou, H., Hou, KM., Ponsonnaille, J., et al.[2007]

The pilot study involving 21 firefighters showed that the advanced 12-lead electrocardiogram (A-ECG) can effectively identify cardiac risk, with only one subject showing signs of coronary artery disease, indicating its potential for early detection of cardiovascular issues.

Firefighters trained to use the A-ECG found the system user-friendly, suggesting that this remote assessment tool could be a practical and cost-effective method for monitoring cardiac health in high-risk environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deployment of remote advanced electrocardiography for improved cardiovascular risk assessment in career firefighters. Dolezal, BA., Abrazado, M., Batalin, MA., et al.[2014]

The ECG247 Smart Heart Sensor demonstrated high-quality ECG monitoring and usability among 13 professional cyclists during intensive training, with an average monitoring duration of 144 hours per athlete.

The device successfully detected potential arrhythmias in 24% of tests, although manual assessments confirmed that most were normal, indicating the sensor's effectiveness in a real-world athletic environment without causing discomfort during training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart rhythm assessment in elite endurance athletes: A better method? Ausland, Å., Sandberg, EL., Jortveit, J., et al.[2022]

The BeyondCare® Patch Monitor demonstrated a high correlation (98%) with standard 12-lead Holter monitoring in detecting heartbeats, indicating its effectiveness in cardiac arrhythmia detection.

The device was well-tolerated by patients, with a mean wear time of 4.7 days and a 93.6% analyzable wear time, allowing for extended monitoring and improved detection of arrhythmias, including new cases identified after the initial monitoring period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The quality of ECG data acquisition, and diagnostic performance of a novel adhesive patch for ambulatory cardiac rhythm monitoring in arrhythmia detection. Karaoğuz, MR., Yurtseven, E., Aslan, G., et al.[2020]

Continuous ambulatory ECG monitoring, especially with Holter systems, significantly improves the detection of transient atrial fibrillation in patients with cryptogenic stroke, even when standard ECG tests are negative.

Recent advancements in wearable ECG technology, including waterproof Holter systems and various forms of wearable monitors, are paving the way for enhanced remote monitoring of heart health and arrhythmias in both athletes and the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Use and Future Needs of Noninvasive Ambulatory Electrocardiogram Monitoring. Ikeda, T.[2021]

In a study involving 583 patients across 27 cardiology practices, the ZOLL Arrhythmia Monitoring System, which combines ECG data with additional biometric information, led to treatment plan changes in 96% of cases, demonstrating its significant impact on patient management.

The integration of biometric data allowed for modifications in medications, follow-up, and lifestyle changes for 64% of patients, suggesting that this next-generation monitoring system enhances the ability of physicians to assess cardiovascular risks and improve overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-generation Mobile Cardiac Telemetry: Clinical Value of Combining Electrocardiographic and Physiologic Parameters. Yoo, D., Bhalla, K., Manyam, H., et al.[2022]

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]

The BIO-GUARD-MI study aims to determine if early detection and treatment of cardiac arrhythmias using implantable cardiac monitors (ICMs) can reduce the risk of major adverse cardiac events in high-risk post-myocardial infarction patients, with an estimated enrollment of 1400 participants.

Remote monitoring through ICMs may enhance clinical outcomes by identifying asymptomatic arrhythmias that could lead to serious complications, highlighting the importance of timely and effective responses to these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial. Jons, C., Sogaard, P., Behrens, S., et al.[2020]

Remote monitoring of implantable pacing or defibrillator devices can significantly improve early detection of arrhythmias and technical issues, offering considerable clinical benefits for heart failure patients compared to usual care, as shown in meta-analyses of randomized studies.

While remote monitoring is not yet widely adopted due to various challenges, it is expected to become an integral part of managing heart failure alongside traditional face-to-face clinical reviews, particularly for patients who may benefit from continuous monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future technologies for remote monitoring in cardiology and evidence from trial data. Acosta-Lobos, A., Riley, JP., Cowie, MR.[2016]

The RM-ALONE trial, involving 445 patients with pacemakers and implantable cardiac defibrillators, demonstrated that remote monitoring (RM) alone is as safe as traditional in-office evaluations, with similar rates of major adverse cardiac events (MACE) between the two groups.

Implementing a home monitoring-only approach significantly reduced the need for in-office evaluations by 79.2%, while also decreasing the time healthcare providers spent per patient, indicating a more efficient surveillance method for cardiac devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE). García-Fernández, FJ., Osca Asensi, J., Romero, R., et al.[2020]

Citations

1. cdx.bostonscientific.com cdx.bostonscientific.com/us/en/patients/cardiac-monitor/bodyguardian-mini.html

BodyGuardian MINI Remote Cardiac Monitors - For Patients The BodyGuardian™ MINI Remote Cardiac Monitor is a small, waterproof, easy-to-wear device that gives doctors robust data on your heart. Learn more here.

2. cdx.bostonscientific.com cdx.bostonscientific.com/us/en/patients/cardiac-monitor/bodyguardian-mini-plus.html

BodyGuardian MINI PLUS Remote Cardiac Monitors The BodyGuardian™ MINI PLUS Remote Cardiac Monitor is a comfortable, waterproof monitor that enables near-real-time data transmission to our monitoring ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6853263/

Continuous Monitoring Using a Wearable Device Detects ... The BodyGuardian device detected clear HR responses after amphetamine administration while subjects were physically active.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/K121197.pdf

k121197 - accessdata.fda.gov Conclusion: We conclude that the results of testing show the BodyGuardian System to be substantially equivalent to the predicate device. Page 3 ...

5. respiratory-therapy.com respiratory-therapy.com/products-treatment/monitoring-treatment/patient-monitoring-products/preventice-inc-introduces-bodyguardian-remote-patient-monitoring-system/

Preventice Introduces BodyGuardian Remote Patient ... A new noninvasive remote monitoring device designed to detect and monitor non-lethal cardiac arrhythmias for ambulatory patients.

6. cdx.bostonscientific.com cdx.bostonscientific.com/us/en/home.html

Boston Scientific Cardiac Diagnostics: BodyGuardian A comfortable, waterproof heart monitor that patients can wear 24/7. A powerful remote ECG device that delivers the data physicians require.