Not yet recruitingNAINTERVENTIONAL

Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

This study looks at two different ways of giving a medicine called adenosine when doctors are checking the blood flow in the tiny vessels of the heart. This test is for people who have a condition called microvascular coronary artery disease. One way is giving adenosine into a vein (intravenously), and the other is directly into the heart's arteries (intracoronarily). The main goal is to see if both methods give similar and reliable results for measuring how well these tiny vessels are working. Researchers will also look at how long the test takes, and if patients experience any chest pain or side effects, to help find the best and safest way to perform this important heart assessment.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Johannes Gutenberg University Mainz

Enrolment target

Start

02 Mar 2027

Estimated completion

31 Aug 2027

Microvascular Coronary Artery Disease

What is this study about?

This study is for people who have a condition affecting the tiny blood vessels in their heart, known as microvascular coronary artery disease. These tiny vessels can sometimes stop enough blood reaching the heart muscle, even if the main arteries are clear. To understand this better, doctors do a special test where they measure how easily blood flows through these vessels. A key part of this test involves giving a medicine called adenosine, which temporarily opens up these blood vessels.

The main idea behind this study is to compare two common ways of giving adenosine during this heart test: one is into a vein (like for a blood test), and the other is directly into the heart's arteries during a procedure. The researchers want to find out if both methods give the same reliable and consistent results. This is important because if one method is found to be more accurate or easier to repeat, it could help doctors make better decisions about diagnosing and treating patients.

Ultimately, this research aims to improve how doctors assess microvascular heart disease. By understanding the best way to give adenosine, they can get clearer pictures of heart health and potentially develop more effective treatments. It's all about making sure patients get the most accurate information about their heart condition.

Key takeaways

This study compares two ways of giving a medicine (adenosine) during a heart test.
It's for people with a condition affecting tiny heart blood vessels (microvascular coronary artery disease).
The goal is to find the most consistent and reliable way to measure heart blood flow.
Participation happens during your already planned heart procedure, with no extra visits.
Findings could help doctors make better diagnoses and treatment decisions in the future.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

You might be able to take part in this study if you are 18 years or older and have a long-lasting heart condition where you experience chest pain or similar symptoms, and your doctor has already decided you need a heart catheterisation procedure.

More specifically, your doctor would need to have planned to check the blood flow in the tiny vessels of your heart as part of your normal care. You'd also need to be willing to take part and be able to understand and sign the consent forms.

You would not be able to join if you are under 18, have certain lung conditions like asthma or severe COPD, or if you have a specific type of heart block (a problem with the heart's electrical system) that isn't already managed by a pacemaker. Also, if you've had certain types of heart bypass surgery or significant blockages in a main heart artery, you wouldn't be suitable for this particular study, nor if you can't give informed consent.

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 ongoing chest pain or similar heart symptoms for which your doctor has planned a heart catheterisation?
Has your doctor also planned to measure the blood flow in your heart's tiny vessels as part of your care?
Do you feel able to understand and sign a consent form for the study?
Do you NOT have severe lung conditions like asthma or specific heart rhythm problems without a pacemaker?
Have you NOT had certain heart bypass surgeries or severe blockages in a main heart artery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first have a thorough chat with the study team to ensure you understand everything and are happy to sign a consent form. All the procedures are done during a single hospital visit that you would be having anyway for your standard heart assessment.

During your heart test, you will receive the medicine adenosine in two different ways at different times, so the doctors can compare the measurements. This involves giving the medicine both into a vein and directly into your heart's arteries during the same session. The study team will take several measurements of your heart's blood flow using special equipment. They will also ask you questions about any chest pain you might have and check for any immediate side effects like dizziness or feeling flushed. There are no extra hospital visits required beyond your planned procedure.

Potential risks and benefits

Participating in this study might help doctors understand your heart condition better, although there's no guarantee of direct personal benefit from the comparison of the two adenosine methods. The information gathered will contribute to improving heart disease diagnosis for future patients. Potential risks are generally linked to the standard heart catheterisation procedure itself, such as bruising or infection at the entry site, and temporary side effects from adenosine like flushing or a brief feeling of shortness of breath. The study also checks for rare but serious side effects like irregular heartbeats. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Center of Cardiology, Cardiology I, university hospital Mainz
Verified postcode
Mainz, Germany

Common questions

What is adenosine?

Adenosine is a medication that temporarily opens up your blood vessels, which helps doctors measure blood flow more accurately during a heart test.

What is microvascular coronary artery disease?

This is a condition where the tiny blood vessels in your heart don't work as well as they should, which can cause symptoms like chest pain, even if your main heart arteries are clear.

Will taking part mean extra hospital trips?

No, all the study activities are done during a single hospital visit that you would be having anyway for your planned heart assessment.

Will I know which way I'm given the adenosine?

Yes, this is an 'open label' study, meaning both you and the doctors will know which method is being used at any given time.

What if I change my mind about taking part?

You are free to withdraw from the study at any point, and your decision will not affect your medical care.

How to find out more

Tommaso Gori, MD, PhD

tomgori@hotmail.com 00496131172829 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.