Digital Thermal Monitoring for Endothelial Dysfunction

Overseen By Dristhi Ragoonanan

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Injury to index finger, Skin toxicity, Neuropathy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called Vendys II to assess blood vessel health in children and young adults undergoing hematopoietic cell transplantation (HCT). The device uses digital thermal monitoring to measure blood vessel response after temporarily restricting blood flow. The trial aims to determine if this method is feasible for children and young adults who are HCT candidates. Suitable participants are those aged 6-26 who are about to undergo or have recently undergone HCT. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future HCT outcomes.

Do I have to stop taking my current medications for this trial?

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

What prior data suggests that the Vendys II device is safe for measuring vascular health?

Research has shown that the Vendys II device, used for checking blood flow, is safe. Studies with similar devices have reported no problems, indicating that people generally tolerate it well.

The FDA has approved the Vendys II, confirming it has passed safety tests for specific uses. As a noninvasive tool, it does not involve surgery or entering the body, making it safer than more invasive treatments.

Overall, evidence suggests that the Vendys II device is safe for measuring blood vessel health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Vendys II Device because it offers a new, non-invasive way to assess blood vessel health by measuring temperature changes in the fingertips. Unlike traditional methods for evaluating endothelial dysfunction, which might require more invasive procedures or complex imaging, this device provides quick and easy monitoring. This approach helps in early identification of potential cardiovascular issues, potentially leading to better prevention strategies and personalized treatment plans.

What evidence suggests that the Vendys II device is effective for evaluating vascular health in children and adolescents undergoing HCT?

Studies have shown that the Vendys II device, used by participants in this trial, effectively measures blood vessel function, crucial for heart and blood health. This device assesses how blood vessels respond to changes in blood flow. It is fully automated and non-invasive, requiring no surgery or needles. Research indicates that it accurately measures changes in blood flow and vessel health. These findings suggest it could benefit patients undergoing treatments like hematopoietic cell transplantation, where monitoring blood vessel health is important. ^{1 3 4 6 7}

Who Is on the Research Team?

Keri Schadler

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 6-26 who are about to undergo or have recently had a hematopoietic cell transplant (HCT). It includes both recipients within a month before/after HCT and healthy donors. Participants must fit the device on their index finger without pain or difficulty, consent to join, and not have skin toxicity or neuropathy affecting device use.

Inclusion Criteria

I am a healthy donor aged 6-26 for hematopoietic cell transplantation.

I have had a stem cell transplant within the last month or plan to have one in the next two weeks.

Willing and eligible to enroll on PA19-0756

Exclusion Criteria

Any subject who does not consent/assent to participation.

You have an injury or deformity on your index finger that would make it impossible to wear the device comfortably.

I cannot use the device comfortably due to skin issues or nerve pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo a single measurement of vascular health using the Vendys II device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse events following the assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vendys II Device

Trial Overview

The study is testing the Vendys II device's ability to measure vascular health in patients undergoing HCT. The FDA-approved tool assesses how well blood vessels can dilate by monitoring temperature changes in the finger after temporarily stopping blood flow.

How Is the Trial Designed?

Group I: Vendys II Device Experimental Treatment 1 Intervention

Your participation in this study will be over after your blood vessel health is measured 1 time with the Vendys II device

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A study involving 56 patients with Continuous Flow-Left Ventricular Assist Devices (CF-LVADs) found that poor endothelial function, measured by the VENDYS® device, is linked to a significantly higher risk of future bleeding events, particularly neurologic bleeds.

The vascular reactivity index (VRI) from the VENDYS® test can effectively predict adverse outcomes, with a VRI less than 1 indicating a 5.56 times greater hazard for bleeding events, suggesting that monitoring endothelial function could be crucial for patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endothelial Dysfunction-related Neurological Bleeds with Continuous Flow-Left Ventricular Assist Devices Measured by Digital Thermal Monitor. Ali, A., Uribe, C., Araujo-Gutierrez, R., et al.[2021]

A new microfluidic device allows for real-time monitoring of endothelial permeability and adhesion protein expression, which are crucial for understanding cardiovascular disease progression.

The study found that changes in endothelial response occur at specific oscillatory shear stress frequencies, indicating that there is a threshold frequency that triggers significant changes in endothelial function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of frequency-dependent endothelial response to oscillatory shear stress using a microfluidic transcellular monitor. Sei, YJ., Ahn, SI., Virtue, T., et al.[2019]

A new method using digital thermal monitoring (DTM) can effectively measure peripheral vascular reactivity, providing a simpler and more cost-effective alternative to traditional Doppler systems.

The study demonstrated that DTM-derived flow signals closely matched those obtained from Doppler sensors, with a reactivity response difference of only +/- 15%, indicating that DTM can reliably assess vascular function in cardiovascular screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital thermal monitoring (DTM) of vascular reactivity closely correlates with Doppler flow velocity. McQuilkin, GL., Panthagani, D., Metcalfe, RW., et al.[2021]

Digital thermal monitoring (DTM) can effectively identify asymptomatic patients at risk for significant coronary artery disease, as indicated by lower temperature rebound (TR) in those with higher Framingham risk scores (FRS) and coronary artery calcium (CAC) levels.

In a study of 233 asymptomatic individuals, DTM measurements showed a stronger correlation with significant CAC than traditional risk assessments, improving predictive accuracy from an area under the ROC curve of 0.66 for FRS to 0.89 when combining TR and FRS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relations between digital thermal monitoring of vascular function, the Framingham risk score, and coronary artery calcium score. Ahmadi, N., Hajsadeghi, F., Gul, K., et al.[2019]

This study demonstrates that photoplethysmography can effectively assess microcirculation and endothelial function by measuring the response to local heating in healthy volunteers, indicating its potential as a novel diagnostic tool.

The method revealed a biphasic increase in the pulsatile component of blood flow in response to local hyperthermia, suggesting that endothelial function can be evaluated based on the dynamics of this response, which is influenced by initial skin temperature and temperature differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Method to Assess Endothelial Function via Monitoring of Perfusion Response to Local Heating by Imaging Photoplethysmography. Kamshilin, AA., Zaytsev, VV., Belaventseva, AV., et al.[2022]

Endo-PAT testing, a new FDA-approved technology, was found to be highly reproducible and feasible for assessing endothelial function in a study of 30 healthy adolescents aged 13 to 19, with a high completion rate of 100%.

The testing resulted in a low median pain score of 1, indicating minimal discomfort for participants, which suggests that Endo-PAT could be a reliable and non-invasive method for evaluating cardiovascular health in young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endothelial pulse amplitude testing: feasibility and reproducibility in adolescents. Selamet Tierney, ES., Newburger, JW., Gauvreau, K., et al.[2022]

In a study of 39 healthy subjects, laser Doppler flowmetry (LD) showed that acetylcholine (ACh) administration resulted in a greater and more sustained increase in skin blood flow compared to reactive hyperemia after arterial occlusion, indicating ACh's strong endothelial-dependent vasodilation effect.

Both laser Doppler measurements and flow-mediated dilation (FMD) of the brachial artery can effectively assess endothelial function, which is important for evaluating cardiovascular risk, and they show a significant correlation despite differences in their measurement methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive assessment of endothelial function - relation between vasodilatory responses in skin microcirculation and brachial artery. Hansell, J., Henareh, L., Agewall, S., et al.[2019]

The study successfully demonstrated a reliable method for assessing flow-mediated dilatation (FMD) in a rodent model using infrared pulse sensors, which is important for studying endothelial function in small animals.

Infusion of acetylcholine significantly increased the dilatation index, indicating enhanced endothelial function, while L-NAME reduced it, confirming the method's effectiveness in evaluating vascular responses similar to those observed in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo assessment of endothelial function in small animals using an infrared pulse detector. Liu, CC., Liu, WM., Wu, HT., et al.[2022]

The study demonstrated that using a thermography catheter in coronary arteries is safe and feasible, with no adverse events reported during the procedures on both rabbit and pig models.

The catheter caused acute but reversible de-endothelialization similar to that seen with intravascular ultrasound (IVUS), indicating that while there is some endothelial damage, it is not permanent and can be clinically acceptable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravascular thermography: Immediate functional and morphological vascular findings. Verheye, S., De Meyer, GR., Krams, R., et al.[2019]

In a study of 60 patients undergoing major thoracic surgery, Digital Thermal Monitoring (DTM) did not show significant changes in vascular reactivity after surgery, suggesting it may not be a reliable indicator of postoperative endothelial function.

Patients with cardiovascular risk factors, such as abdominal obesity and smoking, exhibited lower DTM values, indicating that these factors may influence vascular function and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of digital thermal monitoring as a tool to assess perioperative vascular reactivity. Schier, R., Marcus, HE., Mansur, E., et al.[2023]

Citations

1.

vendys2.com

vendys2.com/endothelial-function-testing-ig

Endothelial Function Test | VENDYS-II is FDA Cleared & ...

Improve patient care and bottom line with VENDYS-II. The first fully automated, office-based, noninvasive Endothelial Function testing device.

2.

vendys2.com

vendys2.com/for-patients

Patients

Endothelial function is a vital component of vascular function that enables adjustments of blood flow and alterations of vessel tone and diameter, when needed.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8984635/

A novel operator-independent noninvasive device for ...

A novel device that provides an automated measurement of the difference between baseline and post-ischemic, hyperemia-induced, brachial arterial compliance.

4.

withpower.com

withpower.com/trial/phase-5-2021-3bc2b

Digital Thermal Monitoring for Endothelial Dysfunction

Trial Overview The study is testing the Vendys II device's ability to measure vascular health in patients undergoing HCT. The FDA-approved tool assesses how ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8758294/

High Frequency of Microvascular Dysfunction in US ...

All DTM tests were performed using a VENDYS device (Endothelix, Palo Alto, CA), a nonimaging, simplified system that fully automates the arm- ...

6.

vendys2.com

vendys2.com/endothelial-function-testing-ev

Endothelial Function Test | VENDYS-II is FDA Cleared & ...

FDA-Cleared & Fully Automated · The only FDA cleared, fully automated, noninvasive vascular reactivity and endothelial function test in the US. · Reimbursable ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5088311/

New Indices of Endothelial Function Measured by Digital ...

DTM measures were correlated with age, sex, heart rate, and systolic and diastolic blood pressure in 6084 patients from 18 clinics.