Continuous Cardiac Monitoring for Heart Arrhythmia
(CARING Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Washington University School of Medicine
Must be taking: Arsenic trioxide, Capecitabine, Ribociclib
Disqualifiers: Younger than 18, others
No Placebo Group
Breakthrough Therapy
Approved in 1 Jurisdiction
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?
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.678910
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.411121314
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.
See 3 more
Exclusion Criteria
I am under 18 years old.
Allergy to adhesive patches
Trial 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 (Cardiac Monitoring Device)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Continuous patch monitoring systemExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
References
The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial. [2020]The increasing use of implantable cardiac monitors (ICMs) allows early documentation of asymptomatic cardiac arrhythmias that would previously have gone unnoticed. The addition of remote monitoring to cardiac devices means that physicians receive an early warning in cases of new-onset arrhythmias. While remote monitoring has been suggested to increase survival in heart failure patients with implantable defibrillators, trials using ICMs for continuous electrocardiographic monitoring of cardiac arrhythmias in the postmyocardial infarction setting have shown that patients who experienced cardiac arrhythmias such as atrial fibrillation, bradycardia, and ventricular tachyarrhythmia have an increased risk of major adverse cardiac events.
Current and future technologies for remote monitoring in cardiology and evidence from trial data. [2016]All major manufacturers of implantable pacing or defibrillator technologies support remote monitoring of their devices. Integration of signals from several monitored variables can facilitate earlier detection of arrhythmia or technical problems, and can also identify patients at risk of deterioration. Meta-analyses of randomized studies of remote monitoring of heart failure using standalone systems suggest considerable clinical benefit when compared with usual care. However, there may be little to be gained by frequently monitoring patients with well-treated stable disease. Trials of implantable monitoring-only devices suggest that there is a subgroup of patients that may benefit from such remote monitoring. Remote monitoring is still not widely adopted due to a number of social, technological and reimbursement issues, but this is likely to change rapidly. Remote monitoring will not replace face-to-face clinical review, but it will be part of the solution to ever increasing numbers of patients with heart failure and/or an implantable device requiring expert input to their care.
Patient perspective and safety of remote monitoring of implantable cardioverter-defibrillators in the Polish Nationwide Multicenter Registry: the Medtronic CareLink network evaluation. [2021]Remote monitoring of cardiovascular implantable electronic devices allows the assessment of system effectiveness, arrhythmia occurrence, and indirectly, clinical changes. Medical interventions can be performed earlier because of a faster transfer of information to the monitoring site, even in the case of asymptomatic arrhythmias or abnormalities in the operation of the system.
The Role of Contemporary Wearable and Handheld Devices in the Diagnosis and Management of Cardiac Arrhythmias. [2022]Cardiac arrhythmias are associated with significant morbidity, mortality and economic burden on the health care system. Detection and surveillance of cardiac arrhythmias using medical grade non-invasive methods (electrocardiogram, Holter monitoring) is the accepted standard of care. Whilst their accuracy is excellent, significant limitations remain in terms of accessibility, ease of use, cost, and a suboptimal diagnostic yield (up to ∼50%) which is critically dependent on the duration of monitoring. Contemporary wearable and handheld devices that utilise photoplethysmography and the electrocardiogram present a novel opportunity for remote screening and diagnosis of arrhythmias. They have significant advantages in terms of accessibility and availability with the potential of enhancing the diagnostic yield of episodic arrhythmias. However, there is limited data on the accuracy and diagnostic utility of these devices and their role in therapeutic decision making in clinical practice remains unclear. Evidence is mounting that they may be useful in screening for atrial fibrillation, and anecdotally, for the diagnosis of other brady and tachyarrhythmias. Recently, there has been an explosion of patient uptake of such devices for self-monitoring of arrhythmias. Frequently, the clinician is presented such information for review and comment, which may influence clinical decisions about treatment. Further studies are needed before incorporation of such technologies in routine clinical practice, given the lack of systematic data on their accuracy and utility. Moreover, challenges with regulation of quality standards and privacy remain. This state-of-the-art review summarises the role of novel ambulatory, commercially available, heart rhythm monitors in the diagnosis and management of cardiac arrhythmias and their expanding role in the diagnostic and therapeutic paradigm in cardiology.
Smartphone-Based Electrocardiographic and Cardiac Implantable Electronic Device Monitoring. [2022]The field of arrhythmia monitoring is changing rapidly. The rapid advent of technology in combination with marked improvements in cellular communication and an increased desire by patients to be actively engaged in their care has ushered in a new era of clinical care. Today, physicians need to think about their patients outside the traditional in-office setting. Two technologies that embody this changing landscape are smartphone-based electrocardiographic (ECG) monitors and remote monitoring of cardiac implantable electronic devices (CIEDs). Smartphone-based ECG monitors allow the patient to assume a greater stake in their own care. They purchase the monitor, couple it to their smartphone, own it forever, and can capture a representative ECG whenever they want to assess symptoms. The physician needs to accept that this approach is vastly different from the use of standard ambulatory external ECG monitors that have been used for years in clinical practice. A similar paradigm shift is underway with respect to the care of the CIED patient. Remote follow-up was once considered an acceptable alternative to in-office calendar-based follow-up of CIEDs. Today, guidelines recommend remote monitoring to be the preferred method for device follow-up. Remote monitoring is tailor-made for the current evolution to a value-based healthcare system, having been demonstrated to reduce scheduled office visits, hospital admissions, and mortality. It is now time to educate patients and physicians on the value of remote monitoring and to ensure that clinical practices develop the infrastructure needed to enroll, monitor, and manage their patients.
Deployment of remote advanced electrocardiography for improved cardiovascular risk assessment in career firefighters. [2014]Firefighters perform strenuous muscular work while wearing heavy, encapsulating personal protective equipment in high temperature environments, under chaotic and emotionally stressful conditions. These factors can precipitate sudden cardiac events in firefighters with underlying cardiovascular disease. The purpose of this pilot study was to deploy and explore the feasibility of the resting "advanced" 12-lead electrocardiogram (A-ECG) as a remote firefighter risk assessment tool for improved assessment of cardiac risk.
Heart rhythm assessment in elite endurance athletes: A better method? [2022]Arrhythmias also occur among elite endurance athletes. Conventional diagnostic tools for assessment of arrhythmias suffer from limited availability and usability challenges, particularly under the demanding training conditions of an elite athlete. Among endurance athletes, there is a need for out-of-hospital monitoring to enhance detection of arrhythmias under conditions that are relevant and potentially provocative of underlying pathology. The Norwegian patch ECG247 Smart Heart Sensor has been developed to simplify the assessment of heart rhythm disorders. The current study aimed to evaluate the ECG247 Smart Heart Sensor function and usability in an elite athlete environment.
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]This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months.
Current Use and Future Needs of Noninvasive Ambulatory Electrocardiogram Monitoring. [2021]Remarkable progress has been seen in monitoring systems using noninvasive ambulatory electrocardiograms (ECGs). In the Holter ECG system, 12-channel formats have been utilized as diagnostic tools, particularly for the detection of transient or silent myocardial ischemia and dynamic electrical disorders. In patients diagnosed with cryptogenic stroke, despite negative results on standard ECG tests, continuous ambulatory ECG monitoring for up to 30 days has been shown to increase the detection rate of transient atrial fibrillation. At present, a waterproof Holter ECG system is available. Recently, continuous late potential measurements using the time domain method and frequency domain T-wave alternans using the spectral analysis method for 24 hours have been applied to the Holter ECG and developed as novel risk stratification markers. Wearable ECG monitors that are built into belts, vests, wristbands, adhesive patches, and mobile smartphones have been used as fitness products for athletes and healthcare products for the general population. In the future, such devices may be used as remote monitoring tools for the detection of arrhythmias.
Next-generation Mobile Cardiac Telemetry: Clinical Value of Combining Electrocardiographic and Physiologic Parameters. [2022]The ZOLL Arrhythmia Monitoring System, a mobile cardiac telemetry (MCT) device from ZOLL Corporation (Chelmsford, MA, USA), records single-channel electrocardiogram (ECG) signals, heart rate, activity, respiratory rate, and posture. Comprehensive reporting from these multiple biometrics may provide a global evaluation of arrhythmic or other cardiovascular risks in individual patients and insights into the patient's overall wellness and health status. The objective of the study was to evaluate the physician-perceived utility of adding biometric data to the traditional ECG-only-based assessment and subject-reported symptoms. This prospective study recruited candidates for MCT. Independent event and end-of-use (EOU) reports based on ECG and biometrics data were provided to physicians. To document whether the biometric data affected treatment plan decisions or added value over the ECG-alone data, physicians completed a questionnaire for each report. Additionally, they completed the questionnaire to understand the utility of the subject wellness information provided in the EOU report. From December 2020 to July 2021, 583 patients were enrolled by 27 physicians from 18 cardiology practices in the United States. When using biometrics data compared to the ECG alone, this study found that 96% of the physicians made changes to the treatment plan that initially was based on the ECG alone. The biometrics-based changes involved 64% of all patients (n = 535), and included modifications to medications, follow-up, and lifestyle in 18%, 19%, and 63% of the subjects, respectively. In this largest MCT study conducted to date, next-generation MCT, by providing multiple biometric parameters along with ECG data, improves physicians' ability to make patient management decisions. This added functionality and clarity may replace traditional "ECG with diary"-based monitoring.
ECG patch monitors for assessment of cardiac rhythm abnormalities. [2022]The primary goal of long-term monitoring is the improvement of diagnostic yield. Despite the clear utility of Holter monitoring in clinical cardiology, issues of relatively low diagnostic yield, cost and inconvenience have motivated the development of ultra-portable devices referred to as ECG patch monitors. Although the "gold standard" for assessing cardiac rhythm abnormalities remains a 12-lead Holter, there is an increasing interest in portable monitoring devices that provide the opportunity for evaluating cardiac rhythm in real-world environments such as the workplace or home. To facilitate patient acceptance these monitors underwent a radical miniaturization and redesign to include wireless communication, water proofing and a patch carrier for attaching devices directly to the skin. We review recent developments in the field of "patch" devices primarily designed for very long-term monitoring of cardiac arrhythmic events. As the body of supporting clinical validation data grows, these devices hold promise for a variety of cardiac monitoring applications. From a clinical and research standpoint, the capacity to obtain longitudinal cardiac activity data by patch devices may have significant implications for device selection, monitoring duration, and care pathways for arrhythmia evaluation and atrial fibrillation surveillance. From a research standpoint, the new devices may allow for the development of novel diagnostic algorithms with the goal of finding patterns and correlations with exercise and drug regimens.
The quality of ECG data acquisition, and diagnostic performance of a novel adhesive patch for ambulatory cardiac rhythm monitoring in arrhythmia detection. [2020]Short and long ambulatory electrocardiographic monitoring with different systems is a widely used method to detect cardiac arrhythmias. In this study, we aimed to evaluate the effectiveness of a novel monitoring device on cardiac arrhythmia detection.
A wireless ECG smart sensor for broad application in life threatening event detection. [2020]A single channel wireless, wearable ECG smart sensor has been developed for long-term monitoring of patients at risk of life-threatening cardiac arrhythmias. The battery-operated sensor can be applied in virtually any orientation on the upper left quadrant of the chest, and monitors patient health continuously for up to three days. An embedded microcontroller calculates heart rate and monitors the ECG signal for life-threatening arrhythmias, which are transmitted wirelessly to a central server and relayed to a respondent device. Tests on human subjects demonstrated signal amplitude from the closely-spaced smart sensor electrodes to be one-half that of the best vector from traditional limb lead placement. Tests with motion and muscle artifact showed superior noise immunity by the smart sensor as compared to a state-of-the-art telemetry monitor.
Remote continuous cardiac arrhythmias detection and monitoring. [2007]The current techniques used to diagnose cardiac arrhythmias such as Holter, Rtest and telemetry systems are partially efficient because they are limited either in time or in space. In this paper, a platform dedicated to the real-time remote continuous cardiac arrhythmias detection and monitoring is proposed. Such a platform allows to improve the accuracy and the efficiency of the diagnostic of ventricular tachycardia among the high-risk patients and enables the implantation of ICD to prevent sudden death. The new method allows the patient to lead a normal life while being remotely monitored in real-time by an ambulatory wireless ECG sensor. When a cardiac arrhythmia is detected a message including a sequence of ECG signals and the patient's images (indoors only) is sent to a remote surveillance server. According to the gravity of the symptom, the cardiologist can intervene in real time or later. The system has been evaluated on some ten patients with regard to heartbeat and cardiac rhythm disturbance. The real-time results are similar to those offered by HP telemetry systems.