Portable Cardiac Monitoring for Childhood Cancer Survivors

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Cancer therapy, Pacemaker, Defibrillator, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The clinical trial compares the reproducibility and accuracy of cardiac tonometry-based portable systems that may detect early cardiac dysfunction (SphygmoCor® Xcel and Oscar 2™ ambulatory blood pressure monitor) at home and in the clinic to currently available screening tests for heart failure including echocardiogram (echo) and cardiovascular magnetic resonance (CMR). The SphygmoCor® Xcel and Oscar 2™ systems may help detect cardiac dysfunction earlier than other available screening tests because it can be self-administered outside of the clinic. This study aims to test the accuracy and practicality of these devices in the clinic setting and at home.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Wireless Synchronized Cardiac Function Monitoring Device, SphygmoCor XCEL, Oscar 2 for childhood cancer survivors?

The research shows that a similar handheld wireless platform, Vivio, accurately detects cardiac dysfunction in childhood cancer survivors, matching the accuracy of cardiac magnetic resonance imaging (CMR). This suggests that portable cardiac monitoring devices can effectively monitor heart health in this population. ^{1 2 3 4 5}

Is portable cardiac monitoring safe for childhood cancer survivors?

The research does not provide specific safety data for portable cardiac monitoring devices like the Wireless Synchronized Cardiac Function Monitoring Device, SphygmoCor XCEL, or Oscar 2, but it does suggest that similar technology (Vivio) is accurate and potentially beneficial for monitoring cardiac function in childhood cancer survivors. ^{1 4 5 6 7}

How is the Wireless Synchronized Cardiac Function Monitoring Device treatment different from other treatments for childhood cancer survivors?

The Wireless Synchronized Cardiac Function Monitoring Device is unique because it provides continuous, real-time monitoring of heart function without the need for hospital visits, using a portable and wireless system. This allows for more freedom and less disruption to the daily lives of childhood cancer survivors compared to traditional cardiac monitoring methods that require frequent hospital visits. ^{8 9 10 11 12}

Research Team

Saro H Armenian

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for childhood cancer survivors who were part of a previous study (IRB# 14154) and can consent to participate. It's not suitable for those currently on cancer treatment or with certain implants like pacemakers, insulin pumps, cochlear implants, aneurysm clips, neural stimulators, metal in the eye, or other medical devices.

Inclusion Criteria

Previously enrolled in IRB# 14154

Able to understand and sign the study specific informed consent form (ICF)

Exclusion Criteria

I do not have any metal implants or devices in my body.

I am not currently undergoing treatment for cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Assessment

Participants undergo a one-time assessment of cardiac function by echo, CMR, and the Tonometry-based system in the clinic over 4-6 hours, and perform home-based measurements within 1-5 days.

1 week

1 visit (in-person), home-based measurements

Follow-up

Participants are monitored for the accuracy and reproducibility of cardiac function measurements over time.

Up to 2 years

Treatment Details

Interventions

• Wireless Synchronized Cardiac Function Monitoring Device

Trial Overview The trial tests new portable systems (SphygmoCor® Xcel and Oscar 2™) against standard heart failure screenings like echocardiograms and cardiac MRIs. These devices could detect early heart issues from home use compared to traditional clinic-based tests.

Participant Groups

Group I: Screening (echo, CMR, Tonometry-based system) Experimental Treatment 4 Interventions

Patients undergo a one time assessment of cardiac function by echo, CMR, and the Tonometry-based system system in the clinic over 4-6 hours, and will be asked to perform their home-based measurements within 1-5 days of the clinical assessment, allowing us to directly compare measurements obtained by survivors to those by research personnel. Patients also complete questionnaires at baseline.

Wireless Synchronized Cardiac Function Monitoring Device is already approved in United States, European Union for the following indications:

Approved in United States as SphygmoCor XCEL for:

• Cardiac dysfunction detection
• Arterial stiffness assessment
• Central blood pressure monitoring

Approved in European Union as SphygmoCor XCEL for:

• Cardiac dysfunction detection
• Arterial stiffness assessment
• Central blood pressure monitoring

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A study involving 191 childhood cancer survivors showed that the handheld mHealth platform (Vivio) accurately assessed cardiac function, with results closely matching those from cardiac magnetic resonance imaging (CMR), indicating its potential for effective real-time monitoring.

In contrast, traditional echocardiography significantly overestimated left ventricular ejection fraction (EF) and had poor sensitivity for detecting cardiac dysfunction, highlighting the advantages of using Vivio for better identification of at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a Novel Handheld Wireless Platform for Detection of Cardiac Dysfunction in Anthracycline-Exposed Survivors of Childhood Cancer. Armenian, SH., Rinderknecht, D., Au, K., et al.[2019]

Long-term survivors of childhood cancer are at an increased risk of cardiovascular disease (CVD) due to treatments like anthracycline chemotherapy and chest radiation, compounded by traditional risk factors over time.

Personalized risk prediction models and ongoing prevention trials are crucial for managing CVD risk in these survivors, highlighting the need for multidisciplinary collaboration in screening and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Disease in Survivors of Childhood Cancer: Insights Into Epidemiology, Pathophysiology, and Prevention. Armenian, SH., Armstrong, GT., Aune, G., et al.[2020]

In a study of 77 childhood cancer survivors (CCSs) who were at least 1 year post-chemotherapy, the prevalence of abnormal left ventricular global longitudinal strain (GLS) increased with exercise stress, indicating some CCSs may have impaired cardiac adaptation during physical activity.

Despite the increased prevalence of abnormal GLS under stress, CCSs showed similar average GLS and strain values compared to healthy controls, suggesting that significant cardiac dysfunction may not be evident early after treatment, particularly in those treated with high-dose anthracyclines or diagnosed before age 5.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Ventricular Strain Analysis During Submaximal Semisupine Bicycle Exercise Stress Echocardiography in Childhood Cancer Survivors. von Scheidt, F., Pleyer, C., Kiesler, V., et al.[2022]

In a study of 601 childhood cancer survivors, 27% exhibited subclinical left ventricular dysfunction, indicating a significant risk of cardiac issues in this population.

The strongest predictors of reduced heart function were younger age at diagnosis, higher cumulative doses of anthracyclines, and radiation to the chest, while high-dose cyclophosphamide and ifosfamide did not show a significant impact on heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac function in 5-year survivors of childhood cancer: a long-term follow-up study. van der Pal, HJ., van Dalen, EC., Hauptmann, M., et al.[2013]

The LATER CARD study aims to assess the prevalence of subclinical cardiac dysfunction in long-term childhood cancer survivors (CCS) compared to sibling controls, involving 1900 CCS and 500 siblings from 2017 to 2020.

By using advanced echocardiographic techniques and biomarkers, the study seeks to improve early detection of cardiac dysfunction, potentially leading to better long-term follow-up guidelines for CCS at risk of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic tools for early detection of cardiac dysfunction in childhood cancer survivors: Methodological aspects of the Dutch late effects after childhood cancer (LATER) cardiology study. Leerink, JM., Feijen, ELAM., van der Pal, HJH., et al.[2020]

In a study of 277 adult childhood cancer survivors (CCS) treated with potentially harmful therapies, there was a significant increase in both systolic and diastolic dysfunction compared to healthy controls, indicating long-term cardiovascular risks.

The prevalence of diastolic dysfunction was notably higher in CCS (12%) compared to controls (1%), and these cardiac issues were linked to the cumulative doses of anthracyclines and mediastinal radiation, suggesting a connection between cancer treatment and early cardiac aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systolic and diastolic dysfunction in long-term adult survivors of childhood cancer. Brouwer, CA., Postma, A., Vonk, JM., et al.[2015]

In a study of 2,715 childhood cancer survivors, major ECG abnormalities were found in 10.7% of participants, significantly higher than the 4.9% observed in community controls, indicating a concerning prevalence of heart issues in this population.

Major ECG abnormalities were linked to higher doses of anthracycline chemotherapy and cardiac radiation, and they were predictive of increased all-cause mortality, with a hazard ratio of 4.0, highlighting the long-term risks faced by childhood cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocardiographic abnormalities and mortality in aging survivors of childhood cancer: A report from the St Jude Lifetime Cohort Study. Mulrooney, DA., Soliman, EZ., Ehrhardt, MJ., et al.[2018]

The ambulatory electrocardiographic (ECG) monitor, developed over 30 years ago, is crucial for detecting silent hemodynamic insufficiency states that can lead to serious organ damage, such as myocardial infarction or stroke.

Research from 1946 to 1971 demonstrated that timely treatment of the underlying causes of regional ischemic states can reverse these insufficiency events, highlighting the importance of early diagnosis and intervention using ECG monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Historical vignette celebrating the 30th anniversary of diagnostic ambulatory electrocardiographic monitoring and data reduction systems. Corday, E.[2019]

The textile-based device (SKIIN) effectively measures heart rate in various activities (lying down, sitting, standing, exercising, and cooling down) with a normalized root mean squared error of around 3.8% for healthy children and 3.6% for those with heart disease, indicating high accuracy compared to standard electrocardiogram measurements.

Participants, including children with heart disease, found the SKIIN device comfortable and easy to wear, suggesting it could improve the quality of life by allowing for more freedom in physical activity while still providing reliable cardiac monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Textile-based Wearable to Monitor Heart Activity in Paediatric Population: A Pilot Study. Montazeri Ghahjaverstan, N., Balmer-Minnes, D., Taghibeyglou, B., et al.[2023]

Wireless hemodynamic monitoring using pulmonary artery pressure sensors is a safe and effective method for assessing heart failure patients, allowing for early detection of worsening conditions without the need for physical exams.

The use of these devices has been shown to improve patient outcomes in heart failure, regardless of whether the patients have preserved or reduced ejection fraction, making it a valuable tool in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless Hemodynamic Monitoring in Patients with Heart Failure. Lander, MM., Aldweib, N., Abraham, WT.[2022]

Real-time cardiac monitors (RTCMs) are effective for long-term monitoring of patients, particularly in detecting transient abnormal ECG events, and are considered safe for clinical use, especially in identifying ventricular arrhythmias.

While RTCMs have advantages in diagnosing and managing cardiac conditions, their algorithms have limitations and cannot analyze certain rhythms like atrial fibrillation or pacemaker rhythms, which may lead to potential errors in detecting serious arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time cardiac monitors. Handelsman, H.[2007]

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]

References

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

Accuracy of a Novel Handheld Wireless Platform for Detection of Cardiac Dysfunction in Anthracycline-Exposed Survivors of Childhood Cancer. [2019]

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

Cardiovascular Disease in Survivors of Childhood Cancer: Insights Into Epidemiology, Pathophysiology, and Prevention. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Left Ventricular Strain Analysis During Submaximal Semisupine Bicycle Exercise Stress Echocardiography in Childhood Cancer Survivors. [2022]

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

Cardiac function in 5-year survivors of childhood cancer: a long-term follow-up study. [2013]

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

Diagnostic tools for early detection of cardiac dysfunction in childhood cancer survivors: Methodological aspects of the Dutch late effects after childhood cancer (LATER) cardiology study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Systolic and diastolic dysfunction in long-term adult survivors of childhood cancer. [2015]

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

Electrocardiographic abnormalities and mortality in aging survivors of childhood cancer: A report from the St Jude Lifetime Cohort Study. [2018]

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

Historical vignette celebrating the 30th anniversary of diagnostic ambulatory electrocardiographic monitoring and data reduction systems. [2019]

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

Textile-based Wearable to Monitor Heart Activity in Paediatric Population: A Pilot Study. [2023]

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

Wireless Hemodynamic Monitoring in Patients with Heart Failure. [2022]

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

Real-time cardiac monitors. [2007]

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

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