Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Plethysmography with acetylcholin and carbacholin – A clinical method study

This study is for people who have a problem with how their blood vessels work. It's called a 'clinical method study,' which means researchers are trying to improve how they measure blood flow. They are using eye drops, which contain special substances called MIOSTAT and Miochol®-E, usually used in eye surgery, to see what happens to blood flow in the arm. The main goal is to test and refine ways to measure how much blood flows through your forearm, both in general and in response to these substances. This is an early-stage study (Phase II) meaning it's still exploring if this measurement method is useful. Participants must be 18 years or older, and both men and women can take part.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Regionshospitalet Godstrup

Enrolment target

Start

25 May 2023

Vascular dysfunction

What is this study about?

This study is called 'Plethysmography with acetylcholin and carbacholin – A clinical method study.' In simple terms, it's about finding better ways to understand and measure how our blood vessels are working, especially when they aren't functioning as they should. The main condition being looked at is called 'vascular dysfunction,' which just means there's a problem with your blood vessels.

The researchers are focusing on measuring blood flow in the forearm. To do this, they are using specific eye drops, which are medicines usually given during eye surgery to make the pupil smaller. These medicines are called MIOSTAT and Miochol®-E. The study wants to see how these eye drops affect the blood flow in your arm and if measuring this is a good way to check the health of your blood vessels.

This is a 'Phase II' study, which means it's an early-stage investigation. Researchers are exploring if this method of using these eye drops and measuring blood flow can give them useful information. It's about developing and testing new techniques to better understand blood vessel problems, rather than testing a specific treatment for a disease.

Key takeaways

The study aims to improve ways of measuring blood flow in forearms.
It uses special eye-drop medicines to see how they affect blood flow.
This is an early-stage study, focusing on research methods.
It is for adults aged 18 and over, with blood vessel problems.
No direct treatment for your condition is expected from this study.

Who may be eligible?

To be able to take part in this study, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate.

Both men and women are welcome to join this study.

The study is specifically for people who have problems with how their blood vessels work. The researchers will be looking for specific health information from you to see if you are a good fit for this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a known condition or concern with your blood vessels?
Are you comfortable with having your arm's blood flow measured?
Are you available for a few study visits, potentially in a hospital setting?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would undergo specific tests to measure the blood flow in your forearm. This involves a technique called 'plethysmography,' which uses a blood pressure cuff-like device to measure changes in arm volume as blood flows through.

You would also be given small doses of the eye drop medicines (MIOSTAT and Miochol®-E) and researchers would then observe and measure how these affect your blood flow. The study is focused on the measurement itself, so there are no long-term treatments or follow-up over many months. The number of visits and the total duration aren't specified in detail, but because it's a 'method study' focusing on immediate responses, it would likely involve a limited number of visits for the testing procedures.

Potential risks and benefits

The main benefit of taking part in this study is helping doctors understand more about how blood vessels work and how to measure problems with them. This could lead to better ways to diagnose or monitor conditions in the future, even if it doesn't directly help you. Potential risks might involve the side effects of the medicines used (MIOSTAT and Miochol®-E), though these are usually used safely in eye surgery, and potentially some discomfort from the blood flow measurements. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What exactly are MIOSTAT and Miochol®-E?

These are medicines, typically used as eye drops during eye surgery. They contain substances that affect blood vessels and other body functions, and the researchers want to see how they impact blood flow in the arm for this study.

Will this study cure my blood vessel problems?

No, this study is not designed to be a treatment or cure for blood vessel problems. It's a method study, which means it's focused on finding better ways to measure and understand these conditions.

What does 'plethysmography' mean?

Plethysmography is a way to measure changes in the size of a body part, like your arm. In this study, it's used to measure how much blood is flowing in and out of your forearm.

How long will I need to be in the study?

The study description doesn't give a specific duration, but because it's about measuring immediate responses to medicines, it's likely to involve a limited number of visits rather than a long-term commitment.

Will I have to pay to join the study?

Clinical trials generally do not charge participants. Any costs associated with the study procedures are typically covered by the research organisers.