Photoplethysmography for Heart Disease

Overseen By Quintrele Jones, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Under 18, Cognitive impairments, others

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

Compensation: Varies

Number of Visits: 2

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how well signals from a device called Photoplethysmography (PPG) can predict heart health details, such as ejection fraction, which measures how well the heart pumps blood. Researchers also aim to determine if PPG can reveal connections between blood pressure and various heart conditions, including heart valve issues or cardiomyopathy (a disease of the heart muscle). The trial targets individuals scheduled for an echocardiogram (a heart ultrasound) at Tulane Medical Center. Participants should be able to wear a Biostrap during their test. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could enhance heart health diagnostics.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Photoplethysmography is safe for use in this study?

Research has shown that photoplethysmography (PPG) is a safe method used in many wearable devices, such as smartwatches. It has long measured changes in blood flow in the body. Studies have found that PPG is well-tolerated, with no reports of harm when used in everyday wearable devices.

PPG sensors use light to monitor blood flow through small vessels under the skin. This non-invasive method, which does not involve inserting anything into the body, keeps the risk of side effects low.

In summary, PPG is considered safe for most people and is already part of many products used regularly without issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using photoplethysmography (PPG) to predict ejection fraction and other echographic data because it offers a non-invasive and potentially more accessible way to gather crucial heart health information. Unlike traditional echocardiograms, which require specialized equipment and trained technicians, PPG uses simple light-based technology that can be integrated into wearable devices. This could make heart monitoring more convenient and widespread, potentially allowing for earlier detection of heart issues in the general population.

What evidence suggests that Photoplethysmography is effective for assessing cardiac conditions?

Research has shown that photoplethysmography (PPG) is a promising tool for assessing heart function. Studies have found a strong link between PPG readings and traditional heart ultrasound results when measuring heart pumping efficiency. Specifically, one study found that PPG and ultrasound results aligned well when measuring heart pumping times. Additionally, PPG has demonstrated high accuracy in detecting heartbeat timings, with one study showing a 94.6% accuracy rate within 100 milliseconds. This trial will explore the effectiveness of PPG in assessing heart health and predicting heart-related issues in patients undergoing echocardiograms. ^{6 7 8 9 10}

Who Is on the Research Team?

Nassir Marrouche, MD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients scheduled to undergo an echocardiogram at Tulane Medical Center.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Data Collection

Participants undergo echocardiography and PPG recording using the Biostrap wristband

1 day

1 visit (in-person)

Analysis

Analysis of the association between echographic imaging features and PPG waveforms to develop a predictive model

Not specified

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Photoplethysmography

How Is the Trial Designed?

Group I: Patient Group Experimental Treatment 1 Intervention

All patients undergoing an echocardiogram at Tulane Medical Center may be asked to participate in the study. Doctors, including PI and co-PI, will identify eligible patients from their clinic using their clinical knowledge and expertise and the patients' medical history and records. They will provide patients with information regarding the study and if interested, patients will be consented prior to their scheduled echocardiogram.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12398815/

Assessing Cardiac Flow Measurements Using a Noninvasive ... This study aims to evaluate a photoplethysmography (PPG)-based wearable monitoring device, which has shown promise in preliminary validations ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022073621001291

The accuracy of heartbeat detection using ... In 180 patients 7914 ECG-, and 7880 (99%) PPG-heartbeats were recorded. The PPG-accuracy within 100 ms was 94.6% (95% CI 94.1–95.1) and 89.2% (95% CI 88.5–89.9) ...

3. akjournals.com akjournals.com/view/journals/2060/112/3/article-p229.xml

A comparison with echocardiography in Our results show a good correlation between PPG-based and echocardiography-derived ejection times (r = 0.648, P < 0.001), though Bland-Altmann ...

4. academic.oup.com academic.oup.com/europace/article/doi/10.1093/europace/euaf085.850/8141356

Evaluating the effectiveness of technical adjustments for ... Of the 30 patients (mean age: 58.1 years, 33.3% female), 20 (66.7%) demonstrated high PPG accuracy at baseline, with a mean of 88.4±5.2% ...

5. journals.plos.org journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0003204

Predicting cardiovascular disease risk using ... We developed a deep learning PPG-based CVD risk score (DLS) to predict the probability of having major adverse cardiovascular events (MACE)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6426305/

A review on wearable photoplethysmography sensors and ... The aim of this article is to briefly consider some of the current developments and challenges of wearable PPG-based monitoring technologies.

7. biomedai.lab.nycu.edu.tw biomedai.lab.nycu.edu.tw/en/wearable-photoplethysmogram-ppg-smart-device-safety-and-functional-test/

Safety and Functional Test of Wearable ... 1.Ingredient review through ingredient list and safety data sheet (SDS) to find potential skin irritants and allergens. 2.Toxicologists perform exposure ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0263224123007145

Photoplethysmograhic sensors, potential and limitations Photoplethysmography (PPG) is an optical technique already integrated into wrist-worn commercial products which presents significant advantages ...

9. mdpi.com mdpi.com/2079-9292/12/13/2923

Photoplethysmography in Wearable Devices Photoplethysmography (PPG) is an affordable and straightforward optical technique used to detect changes in blood volume within tissue microvascular beds.

10. slatesafety.com slatesafety.com/revolutionizing-workplace-safety-ppg-sensors/

PPG Sensors: The Future of Safety Wearables Learn how PPG sensors shape the future of safety wearables, with innovative solutions for heat stress management and setting new standards in workplace ...