Prototype Monitor for Heart Disease

Overseen By Kate Calligy, BSN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors measure heart function during cardiac catheterization. Researchers are testing a new device, the Research Prototype Monitor, to develop a better method for calculating cardiac output, which measures how well the heart pumps blood. They seek participants already scheduled for cardiac catheterization who will be under general anesthesia during the procedure. Those fitting this description could help advance heart health technology by joining the trial. As an unphased trial, this study offers a unique opportunity to contribute to pioneering advancements in cardiac care technology.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this prototype monitor is safe for heart disease patients?

Research shows that wearable devices, like the Research Prototype Monitor, are generally safe and easy to use. Studies have found that these devices can accurately detect heart problems, such as irregular heartbeats, and help monitor heart failure without causing harm. Although specific safety data for this exact prototype is unavailable, similar devices have successfully managed heart conditions. These monitors are noninvasive, meaning they don't require surgery or enter the body, which lowers the risk of side effects. Overall, existing research suggests that these monitors are safe for managing heart disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional heart disease monitoring methods, which often rely on periodic check-ups and static data, the Research Prototype Monitor offers continuous, real-time monitoring of heart health. This device stands out because it provides dynamic insights into heart function, potentially catching issues earlier than standard monitors like Holter monitors or event recorders. Researchers are excited about this trial because it could transform how we track heart disease, making it possible to intervene more swiftly and prevent complications before they escalate.

What evidence suggests that this prototype monitor is effective for heart disease?

Studies have shown that using technology to monitor the heart can help detect problems early and manage heart disease more effectively. Research indicates that devices like the Research Prototype Monitor, used by participants in this trial, accurately identify issues such as irregular heartbeats and provide valuable information for managing heart failure. These tools have the potential to transform heart care by enhancing how heart health is tracked and addressed. Initial findings suggest these devices enable doctors to monitor patients' heart conditions more effectively, leading to improved care and outcomes. Thus, the monitor could be a valuable tool for maintaining healthier hearts. ^{2 3 6 7 8}

Who Is on the Research Team?

Danielle Gottlieb Sen, MD, MPH

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for cardiac catheterization to measure heart output and who will be under general anesthesia. A parent or guardian must provide consent if the participant is a minor.

Inclusion Criteria

I am scheduled for a heart catheter test to measure blood flow and oxygen.

I am scheduled for a heart procedure under general anesthesia.

Parent/Guardian able to provide informed consent

Exclusion Criteria

I am not scheduled for general anesthesia for heart catheterization.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Cardiac Catheterization

Participants undergo cardiac catheterization while impedance is measured to build a cardiac output algorithm

Up to 12 hours

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Research Prototype Monitor

Trial Overview The study aims to develop a non-invasive method to calculate heart output by measuring impedance during cardiac catheterization using a research prototype monitor.

How Is the Trial Designed?

Group I: Research Prototype Monitor Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

The Patient Care Monitor (PCM) demonstrated high internal consistency across its three main scales (Cronbach alpha 0.94-0.95) and good consistency in its six subscales (Cronbach alpha 0.80-0.95), indicating it is a reliable tool for assessing patient-reported outcomes in oncology.

An exploratory factor analysis revealed that a three-factor model, representing emotional function, physical function, and physical symptoms, better reflects patient experiences than the originally proposed six-factor model, suggesting a more accurate conceptualization of symptoms and concerns in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploratory Factor Analysis of the Scale Structure of the Patient Care Monitor Version 2.0. Samsa, GP., Wolf, S., LeBlanc, TW., et al.[2020]

The Patient Care Monitor 2.0 (PCM 2.0) has been validated as an effective electronic patient-reported outcomes tool for assessing symptoms in cancer patients, based on a study involving 275 participants across breast, gastrointestinal, and lung cancer populations.

PCM 2.0 demonstrated strong internal consistency and construct validity, correlating significantly with established quality-of-life measures, indicating it can reliably capture patient experiences and symptoms in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients. Abernethy, AP., Zafar, SY., Uronis, H., et al.[2022]

The Intellicor prototype is a mobile and web-based application designed to help patients self-monitor their heart sounds, enabling them to register and review heart signal recordings, which can enhance their understanding of their heart health.

Feedback from medical experts indicates that such a system could improve patient-physician communication and data collection, suggesting that further development in collaboration with clinical experts could lead to significant benefits for both patients and the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intellicor: Mobile Design for Monitoring Phonographic Signals. Wist Jakobsen, M., Babic, A.[2022]

The MONITORIA device is designed for comprehensive, non-invasive home monitoring of heart failure (HF) patients, aiming to improve management by continuously measuring critical health variables.

Current literature lacks large randomized studies on the impact of remote monitoring on HF management, highlighting the need for innovative solutions like MONITORIA that focus on patient-specific needs rather than just the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MONITORIA: The start of a new era of ambulatory heart failure monitoring? Part I - Theoretical Rationale. Martins, C., Machado da Silva, J., Guimarães, D., 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]

The white paper highlights the importance of long-term electrocardiographic safety monitoring in clinical drug development, emphasizing the need for ongoing discussions among stakeholders.

A Think Tank organized by the Cardiac Safety Research Consortium explored how new ambulatory monitoring technologies could enhance drug development processes, although the paper does not provide regulatory guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium. Piccini, JP., Clark, RL., Kowey, PR., et al.[2017]

The Cardiac Safety Research Consortium (CSRC) has access to a subset of ECG data from the FDA ECG Warehouse, which can be used for research on cardiovascular safety and efficacy of new drugs, enhancing the understanding of cardiac risks.

Utilizing previously collected ECG data for secondary analyses can significantly improve cardiovascular safety assessments, aligning with current guidelines that require thorough QT studies to evaluate the effects of new drugs on heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research implications of the FDA ECG warehouse and related resources. Green, CL.[2021]

The workshop highlighted the urgent need to fully understand and characterize the incidence and impact of drug-induced cardiovascular issues throughout the drug development process to reduce safety liabilities.

There is a critical requirement for better predictive models and assays that can accurately forecast clinical outcomes related to cardiovascular safety, as well as a deeper mechanistic understanding of these liabilities to improve drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines? Laverty, H., Benson, C., Cartwright, E., et al.[2022]

The study emphasizes the need to expand cardiovascular safety assessments beyond just electrocardiogram events to include a wider range of cardiovascular parameters, using real-life case studies to demonstrate progress.

To enhance the prediction of cardiovascular events in patients, the development of more relevant humanized models is essential, allowing for better translation of findings to novel therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future approaches to nonclinical cardiovascular safety assessment. Collins, TA., Rolf, MG., Pointon, A.[2021]

A comprehensive risk-based monitoring strategy implemented by BIOTRONIK for clinical trials involving implantable cardiac devices showed significant improvements in data quality over one year, particularly in follow-up compliance, critical data availability, and noncompliance rates.

The data-driven risk assessment methodology effectively identified high-risk sites among 133 investigator locations with 3442 subjects, leading to targeted monitoring efforts that resulted in statistically significant enhancements in data quality at the worst performing sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the effectiveness of a risk-based monitoring approach implemented with clinical trials involving implantable cardiac medical devices. Diani, CA., Rock, A., Moll, P.[2019]

The heart failure (HF) training program improved patients' self-care maintenance and confidence significantly more than usual care, suggesting that training can enhance patients' ability to manage their condition.

Despite these improvements in self-care, the training did not lead to a significant difference in event-free survival (such as death or hospitalization) at 90 days between the intervention and usual care groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure symptom monitoring and response training. Jurgens, CY., Lee, CS., Reitano, JM., et al.[2022]

The novel ECG monitor utilizes an ARM controller and features a Liquid Crystal Display for real-time visualization of heart activity, enhancing patient monitoring capabilities.

Equipped with an alarm for abnormalities and the ability to store data on an SD card, this portable device allows for dynamic ECG monitoring, making it a practical tool for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A wireless ECG monitor based on ARM]. Fan, AH., Bian, CH., Ning, XB., et al.[2009]

The Biomon-HF project developed and tested innovative sensors for monitoring vital signs during sleep in 115 heart failure patients, showing promise for personalized telemonitoring and therapy management.

These sensors can help detect heart failure exacerbations and related health issues early, potentially reducing complications and healthcare costs while improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized biomonitoring in heart failure--Biomon-HF "Keep an eye on heart failure--especially at night". Vollmer, T., Schauerte, P., Zink, M., et al.[2015]

The remote patient self-monitoring system combines intelligent phonocardiography with mobile and web platforms, allowing patients to track their heart health and enabling physicians to access and review patient data conveniently.

Two prototypes were developed: one for patients to measure and understand their heart sounds, and another for physicians to monitor patient data and conduct consultations, highlighting the need for clinical validation before implementation in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Self-Monitoring Using Intelligent Phonocardiography on a Mobile Platform. Jakobsen, M., Babic, A.[2023]

The MONITORIA device is designed for comprehensive, non-invasive home monitoring of heart failure (HF) patients, addressing the need for better management strategies in this chronic condition.

Unlike previous studies that focused on single variables, MONITORIA aims to track multiple critical factors simultaneously, potentially improving patient care and outcomes in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MONITORIA: The start of a new era of ambulatory heart failure monitoring? Part I - Theoretical Rationale. Martins, C., Machado da Silva, J., Guimarães, D., et al.[2021]

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