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Study on Vascular Dysfunction: Comparing Acetylcholine Chloride and Carbachol for Forearm Blood Flow Evaluation in Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying *vascular dysfunction*, which refers to problems with blood vessels that can affect blood flow. The study is investigating two treatments: *carbachol* and *acetylcholine chloride*. These are substances used to help understand how blood flows in the forearm. The purpose of the study is to see if *carbachol* is as effective as *acetylcholine chloride* in measuring blood flow in the forearm.

Participants in the study will receive either *carbachol* or *acetylcholine chloride* through a method called *intraocular instillation solution*, which involves applying the solution directly to the eye. The study will use a technique called *plethysmography* to measure blood flow. This method involves gently restricting blood flow in the arm to see how well the blood vessels work. The study aims to compare the effects of the two substances on blood flow.

The study will take place over a short period, with participants receiving the treatment and having their blood flow measured. The goal is to gather information on how these substances affect blood flow, which could help in understanding and treating *vascular dysfunction* in the future. Participants will not be informed about whether they are receiving *carbachol*, *acetylcholine chloride*, or a placebo during the study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as age, health status, and body mass index (BMI).
You will be informed about the study's purpose, which is to assess the effectiveness of two substances, carbachol and acetylcholine, in measuring blood flow in the forearm.
Step 2
Medication administration
You will receive an intraocular instillation solution containing either carbachol or acetylcholine chloride. This solution is administered directly into the eye.
The purpose of this administration is to evaluate the blood flow in your forearm using a method called plethysmography, which measures changes in volume within an organ or whole body.
Step 3
Monitoring and assessment
After the medication is administered, your forearm blood flow will be monitored. This involves measuring both relative and absolute blood flow to assess the effectiveness of the substances.
The monitoring process is non-invasive and aims to provide data on how well the substances work in evaluating blood flow.
Step 4
Follow-up visits
You may be required to attend follow-up visits to monitor any changes or effects resulting from the medication.
These visits are important to ensure your safety and to gather additional data for the study.
Step 5
Completion of study
The study is expected to conclude by May 1, 2025. Upon completion, you will be informed about the study's findings and any relevant information regarding your participation.
Your contribution to the study will help in understanding the effectiveness of carbachol and acetylcholine in measuring blood flow.

Who can join the trial?

4 criteria

Must be a healthy man or woman.
Age must be between 18-40 years.
If you are a woman who can have children, you must use contraceptive treatment (methods to prevent pregnancy).
Your Body Mass Index (BMI) must be between 18.5-30 kg/m². BMI is a measure that uses your height and weight to work out if your weight is healthy.

Who cannot join the trial?

1 criterion

Patients with **vascular dysfunction** cannot participate. This means if you have problems with your blood vessels, you may not be eligible.

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Region Midtjylland
Aarhus, Denmark

Trial locations

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Investigated drugs

Acetylcholine
is a medication used in this study to help measure blood flow in the forearm. It works by causing blood vessels to widen, which increases blood flow. This helps researchers understand how well blood is moving through the forearm and can be used to compare with other medications.
Carbachol
is another medication used in the study to measure blood flow in the forearm, similar to acetylcholine. It also causes blood vessels to widen, which helps increase blood flow. The study aims to see if carbachol is as effective as acetylcholine in evaluating blood flow in the forearm.

What is already known about the treatment

Acetylcholine
Acetylcholine is administered through injection and is used in clinical settings to study blood flow in the forearm. It is currently being researched to understand its effectiveness in measuring blood flow compared to other substances. The main therapeutic use of acetylcholine in this context is to assess vascular function. At the molecular level, acetylcholine works by binding to receptors on blood vessels, causing them to widen and increase blood flow. It is classified as a neurotransmitter and plays a role in the parasympathetic nervous system.
Carbachol
Carbachol is also administered via injection and is used in clinical trials to evaluate blood flow in the forearm, similar to acetylcholine. It is being studied to determine if it can effectively measure blood flow in comparison to acetylcholine. The primary therapeutic indication for carbachol in this study is to assess vascular function. Carbachol acts at the molecular level by mimicking acetylcholine, binding to the same receptors, and causing blood vessels to widen, thus increasing blood flow. It is classified as a cholinergic agonist, which means it stimulates the same receptors as acetylcholine.

Investigated diseases

Vascular dysfunction – Vascular dysfunction refers to the impaired function of blood vessels, which can affect the regulation of blood flow and pressure. It often involves the endothelium, the inner lining of blood vessels, which plays a crucial role in maintaining vascular health. When the endothelium is damaged or not functioning properly, it can lead to reduced vasodilation, increased inflammation, and a higher risk of blood clot formation. Over time, these changes can contribute to the development of various cardiovascular conditions. The progression of vascular dysfunction can vary, but it generally involves a gradual worsening of blood vessel function. This condition can affect different parts of the body, leading to symptoms depending on the specific vessels involved.