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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm.

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 data supports the idea that Prototype Monitor for Heart Disease (also known as: Research Prototype Monitor, Research Prototype Monitor) is an effective treatment?

The available research shows that the Prototype Monitor for Heart Disease, also known as MONITORIA, is designed to improve heart failure management by allowing continuous and non-invasive monitoring of important health factors at home. Although there are no large studies yet to confirm its impact, the device is considered promising because it focuses on adapting care to the needs of patients rather than just the disease itself. This approach could potentially optimize patient care and reduce mortality rates. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Research Prototype Monitor for heart disease?

The MONITORIA device, which is similar to the Research Prototype Monitor, is designed to improve heart failure management by enabling continuous and non-invasive monitoring of critical health factors at home. Although there are no large studies yet, the theoretical basis suggests it could help optimize patient care by adapting to individual needs. ^{1 2 3 4 5}

What safety data exists for the Prototype Monitor for Heart Disease?

The provided research does not directly mention safety data for the Prototype Monitor for Heart Disease or its alternative names. However, it discusses general cardiovascular safety monitoring and risk-based monitoring approaches in clinical trials, which could be relevant to the safety assessment of such devices. The Cardiac Safety Research Consortium and FDA ECG Warehouse are involved in evaluating cardiovascular safety, which may indirectly relate to the safety of similar monitoring technologies. ^{6 7 8 9 10}

What safety data exists for the Prototype Monitor for Heart Disease?

The articles discuss general cardiovascular safety monitoring and improvements in data quality for cardiac device trials, but they do not provide specific safety data for the Prototype Monitor for Heart Disease. ^{6 7 8 9 10}

Is the Research Prototype Monitor a promising treatment for heart disease?

Yes, the Research Prototype Monitor is promising because it allows patients to easily monitor their heart signals, helps them understand their heart health, and improves communication with doctors. It can gather important data that is usually hard to get, which can benefit both patients and healthcare providers. ^{11 12 13 14 15}

How does the Research Prototype Monitor treatment differ from other heart disease treatments?

The Research Prototype Monitor is unique because it focuses on self-monitoring of heart sounds using a mobile and web-based platform, allowing patients to track and understand their heart signals in real-time. This approach enhances patient awareness and communication with physicians, which is not typically available with standard heart disease treatments. ^{11 12 13 14 15}

Research Team

Danielle Gottlieb Sen, MD, MPH

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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 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 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 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]

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

MONITORIA: The start of a new era of ambulatory heart failure monitoring? Part I - Theoretical Rationale. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

MONITORIA: The start of a new era of ambulatory heart failure monitoring? Part I - Theoretical Rationale. [2021]

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

Heart failure symptom monitoring and response training. [2022]

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

An Exploratory Factor Analysis of the Scale Structure of the Patient Care Monitor Version 2.0. [2020]

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

Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients. [2022]

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

Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium. [2017]

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

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

8. England pubmed.ncbi.nlm.nih.gov

How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines? [2022]

9. England pubmed.ncbi.nlm.nih.gov

Current and future approaches to nonclinical cardiovascular safety assessment. [2021]

10. England 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. [2019]

11. China pubmed.ncbi.nlm.nih.gov

[A wireless ECG monitor based on ARM]. [2009]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Intellicor: Mobile Design for Monitoring Phonographic Signals. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Individualized biomonitoring in heart failure--Biomon-HF "Keep an eye on heart failure--especially at night". [2015]

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

Patient Self-Monitoring Using Intelligent Phonocardiography on a Mobile Platform. [2023]

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

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