What is the mechanism of action of this treatment?

Endothelial dysfunction treatments focus on improving vasodilation, reducing inflammation, and preventing thrombosis. Common approaches include lifestyle changes like smoking cessation and exercise, pharmacological agents such as statins, ACE inhibitors, and antiplatelet drugs, and dietary supplements like antioxidants. These treatments enhance nitric oxide availability, reduce oxidative stress, and improve blood flow. Devices like Vendys II, which assess vascular reactivity through digital thermal monitoring after blood flow restriction, are crucial for early detection and monitoring, guiding effective therapeutic interventions for better cardiovascular health.

What side effects are associated with this type of intervention?

Common treatments for endothelial dysfunction include lifestyle modifications, pharmacologic agents, and non-pharmacologic interventions. Statins, often used to improve endothelial function, can cause muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. ACE inhibitors may lead to cough, elevated blood potassium levels, and kidney dysfunction. Antiplatelet agents like aspirin can cause gastrointestinal bleeding and ulcers. Exercise therapy, while generally safe, may result in musculoskeletal injuries if not performed correctly. These treatments aim to improve vascular health but come with potential side effects that should be monitored by healthcare providers.

What prior FDA approvals exist?

FDA-approved treatments for endothelial dysfunction include various pharmacologic agents and devices aimed at improving vascular health. Notably, drugs such as statins, ACE inhibitors, and ARBs have been approved for their benefits in enhancing endothelial function. Additionally, non-invasive devices like the EndoPAT, which measures endothelial function through peripheral arterial tone, have been approved. These treatments and devices focus on improving or assessing vascular reactivity, similar to the digital thermal monitoring method used in the Vendys II trial.

What other types of research exist?

Promising alternatives to Vendys II for assessing vascular reactivity in endothelial dysfunction patients include: 1) EndoPAT (Peripheral Arterial Tone) which measures changes in arterial tone using finger plethysmography, 2) FMD (Flow-Mediated Dilation) which uses ultrasound to measure brachial artery dilation, and 3) Laser Doppler Flowmetry which assesses microvascular blood flow and endothelial function. These methods have shown potential in clinical studies and are expected to be viable options by 2024.

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Digital Thermal Monitoring for Endothelial Dysfunction

N/A

Recruiting

Led By Kris Mahadeo

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Healthy HCT donors between the ages of 6-26 years of age.

Recipients within 30 days prior to or within 14 days after autologous and allogeneic HCT.

Must not have

Any subject with skin toxicity or neuropathy which prevents comfortable use of the device.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive digital thermal monitoring with the Vendys II device, there are minimal expected side effects. However, discomfort at the site of application due to pressure from the device could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Select...

I am between 6 and 26 years old and a candidate for a stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vendys II DeviceExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endothelial dysfunction treatments focus on improving vasodilation, reducing inflammation, and preventing thrombosis. Common approaches include lifestyle changes like smoking cessation and exercise, pharmacological agents such as statins, ACE inhibitors, and antiplatelet drugs, and dietary supplements like antioxidants. These treatments enhance nitric oxide availability, reduce oxidative stress, and improve blood flow. Devices like Vendys II, which assess vascular reactivity through digital thermal monitoring after blood flow restriction, are crucial for early detection and monitoring, guiding effective therapeutic interventions for better cardiovascular health.

Soya isoflavone-enriched cereal bars affect markers of endothelial function in postmenopausal women.

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Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,651 Total Patients Enrolled

1 Trials studying Endothelial Dysfunction

90 Patients Enrolled for Endothelial Dysfunction

Kris MahadeoPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

500 Total Patients Enrolled

Dristhi RagoonananPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

500 Total Patients Enrolled

Media Library

Vendys II Device Clinical Trial Eligibility Overview. Trial Name: NCT05029752 — N/A

Endothelial Dysfunction Research Study Groups: Vendys II Device

Endothelial Dysfunction Clinical Trial 2023: Vendys II Device Highlights & Side Effects. Trial Name: NCT05029752 — N/A

Vendys II Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT05029752 — N/A

~17 spots leftby Jun 2026

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