Continuous Cardiac Monitoring for Heart Arrhythmia

(CARING Trial)

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

Trial Summary

What is the purpose of this trial?

This trial aims to test a small, wearable patch that continuously monitors heart activity. It focuses on patients taking medications that could lead to heart problems. The goal is to see if this patch is as effective as standard heart monitoring methods like electrocardiograms (ECGs).

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 data supports the effectiveness of the treatment BodyGuardian Heart and BodyGuardian Remote Monitoring System for heart arrhythmia?

Research shows that remote monitoring of heart devices can help doctors detect heart rhythm problems earlier, which can lead to quicker medical interventions. This approach has been shown to reduce hospital visits and improve survival rates in patients with heart conditions. ^{1 2 3 4 5}

Is continuous cardiac monitoring for heart arrhythmia safe for humans?

The safety of remote cardiac monitoring systems, like the BodyGuardian, is generally supported by studies on similar devices, which have been used safely for monitoring heart conditions in various populations, including those with pacemakers and athletes. These systems are designed to be noninvasive and have been used in long-term monitoring without significant safety concerns. ^{6 7 8 9 10}

How is the BodyGuardian Heart treatment different from other treatments for heart arrhythmia?

The BodyGuardian Heart treatment is unique because it uses a small, wearable device that continuously monitors heart rhythms in real-time, allowing patients to go about their daily lives while being remotely monitored. This contrasts with traditional methods like Holter monitors, which are less convenient and have a lower diagnostic yield due to limited monitoring duration. ^{4 11 12 13 14}

Research Team

Joshua D Mitchell, M.D., FACC

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

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

I am starting treatment with ribociclib for my solid tumor.

Exclusion Criteria

I am under 18 years old.

Allergy to adhesive patches

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Current and future technologies for remote monitoring in cardiology and evidence from trial data. [2016]

3. Poland 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. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

The Role of Contemporary Wearable and Handheld Devices in the Diagnosis and Management of Cardiac Arrhythmias. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Deployment of remote advanced electrocardiography for improved cardiovascular risk assessment in career firefighters. [2014]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Heart rhythm assessment in elite endurance athletes: A better method? [2022]

8. England 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). [2020]

9. Japan pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Next-generation Mobile Cardiac Telemetry: Clinical Value of Combining Electrocardiographic and Physiologic Parameters. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. United States 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. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

A wireless ECG smart sensor for broad application in life threatening event detection. [2020]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Remote continuous cardiac arrhythmias detection and monitoring. [2007]