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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial measures how well blood vessels work by checking finger temperature changes after stopping and restarting blood flow. It focuses on children and young adults undergoing a major medical procedure. The goal is to see if this method can effectively measure their vascular health.

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 data supports the idea that Digital Thermal Monitoring for Endothelial Dysfunction is an effective treatment?

The available research shows that Digital Thermal Monitoring (DTM) is useful for assessing vascular function, which is important for understanding endothelial dysfunction. One study found that DTM correlates with known coronary artery disease, suggesting it can effectively monitor vascular health. However, the research does not directly show DTM as a treatment but rather as a tool for assessment. There is no direct comparison to other treatments for endothelial dysfunction in the provided data. ^{1 2 3 4 5}

What safety data exists for Digital Thermal Monitoring for Endothelial Dysfunction?

The safety of Digital Thermal Monitoring (DTM) for assessing endothelial dysfunction is supported by studies that demonstrate its noninvasive nature and its correlation with established methods like Doppler flow velocity. The VENDYS® device, used in a study with patients having Continuous Flow-Left Ventricular Assist Devices, showed no association with adverse events, indicating its safety in clinical settings. ^{1 2 3 6 7}

Is Digital Thermal Monitoring a promising treatment for endothelial dysfunction?

Digital Thermal Monitoring is a promising treatment because it offers a non-invasive way to assess endothelial function, which is important for detecting early signs of heart disease. It uses temperature changes to evaluate how well blood vessels are working, making it easier to identify problems early on. ^{1 2 8 9 10}

Research Team

Dristhi Ragoonanan, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

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]

References

1. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

In vivo assessment of endothelial function in small animals using an infrared pulse detector. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Intravascular thermography: Immediate functional and morphological vascular findings. [2019]

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

Endothelial pulse amplitude testing: feasibility and reproducibility in adolescents. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Evaluation of digital thermal monitoring as a tool to assess perioperative vascular reactivity. [2023]

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

Relations between digital thermal monitoring of vascular function, the Framingham risk score, and coronary artery calcium score. [2019]

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

Endothelial Dysfunction-related Neurological Bleeds with Continuous Flow-Left Ventricular Assist Devices Measured by Digital Thermal Monitor. [2021]

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

Digital thermal monitoring (DTM) of vascular reactivity closely correlates with Doppler flow velocity. [2021]

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

Non-invasive assessment of endothelial function - relation between vasodilatory responses in skin microcirculation and brachial artery. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Method to Assess Endothelial Function via Monitoring of Perfusion Response to Local Heating by Imaging Photoplethysmography. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Detection of frequency-dependent endothelial response to oscillatory shear stress using a microfluidic transcellular monitor. [2019]