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Study on Colchicine for Patients with Angina Symptoms and Coronary Microvascular Disease

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 a condition known as Coronary Microvascular Disease (CMD), which affects the small blood vessels in the heart and can cause chest pain, known as angina, even when larger coronary arteries are not blocked. The study will explore the effects of a medication called Colchicine, which is commonly used to treat inflammation, on improving blood flow in these small vessels. Participants in the study will receive either Colchicine 500 microgram Tablets or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to see if Colchicine can improve blood flow in the heart and reduce symptoms in patients with CMD. The study will last for about six months. During this time, participants will undergo various assessments, including heart scans, to measure changes in blood flow and symptom questionnaires to evaluate any changes in their angina symptoms. The study will also look at how Colchicine affects certain proteins and functions in the blood vessels.

In addition to Colchicine, the study will involve the use of Regadenoson and Adenosine, which are substances used to stress the heart during certain tests, and local anesthetics, which are used to numb specific areas of the body. These substances will help researchers better understand the effects of Colchicine on heart function and blood flow. The study aims to provide valuable insights into potential new treatments for CMD and improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the clinical trial, you will be informed about the study's purpose, procedures, and your role as a participant. You will be asked to provide informed consent, which means you agree to participate after understanding all aspects of the trial.
Step 2
Initial assessment
You will undergo an initial assessment to confirm eligibility. This includes a test called [15O]H2O-PET-scan to measure your myocardial blood flow reserve (MBFR) and hyperemic myocardial blood flow (hMBF). These tests help determine if you have coronary microvascular disease (CMD) without obstructive coronary artery disease (CAD).
Step 3
Medication administration
If eligible, you will be assigned to receive either Colchicine 500 microgram Tablets or a placebo. A placebo is a substance with no active medication, used to compare effects. You will take the assigned tablets orally, as directed by the study team.
Step 4
Ongoing monitoring
Throughout the trial, you will have regular check-ups to monitor your health and any changes in symptoms. You may be asked to complete questionnaires, such as the Seattle Angina Questionnaire, to assess symptom burden.
Step 5
Follow-up assessments
After six months, you will undergo another [15O]H2O-PET-scan to assess changes in your myocardial blood flow reserve and hyperemic myocardial blood flow. This helps evaluate the effect of the treatment.
Step 6
Study completion
Once the trial period is over, you will have a final assessment to review your overall health and any changes observed during the study. The study team will discuss the results with you and provide any necessary follow-up care.

Who can join the trial?

6 criteria

Must have CMD (Coronary Microvascular Disease), which means the small blood vessels in the heart are not working properly.
Must have a myocardial blood flow reserve (MBFR) of less than 2.5 or a hyperemic myocardial blood flow (hMBF) of less than 2.3 ml/g/min. These are measures of how well blood flows through the heart.
Must not have obstructive CAD (Coronary Artery Disease), which means there are no blockages in the main heart arteries, as determined by a special heart scan called [15O]H2O-PET.
Must be within the age range of 18 to 65 years old.
Both males and females can participate.
Participants should not be from a vulnerable population, meaning they should not be in a situation that makes them more at risk or in need of special protection.

Who cannot join the trial?

8 criteria

Patients with other serious heart conditions that are not related to **coronary microvascular disease** (CMD) cannot participate.
Individuals who have had a heart attack or stroke in the last 6 months are excluded.
Patients with severe liver or kidney disease are not eligible.
People with uncontrolled high blood pressure cannot join the study.
Individuals with a history of severe allergic reactions to medications are excluded.
Pregnant or breastfeeding women cannot participate.
Patients currently participating in another clinical trial are not eligible.
Individuals with any condition that the study doctors believe would make it unsafe for them to participate are excluded.

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Bispebjerg Hospital
Copenhagen, Denmark

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Investigated drugs

Colchicine is a medication that is being studied for its potential to improve blood flow in the heart. It is often used to treat inflammation and is being tested to see if it can help people who have chest pain due to small blood vessels in the heart not working properly. The goal is to see if colchicine can help these blood vessels work better, which might reduce chest pain and improve heart health.

What is already known about the treatment

Colchicine – Colchicine is administered orally in the form of tablets. It is currently being studied for its potential benefits in treating patients with ischemia who have no obstructive coronary artery disease but suffer from microvascular dysfunction. The main therapeutic indication being explored is its ability to improve coronary flow and coronary flow reserve, which are important for heart health, especially in patients experiencing angina symptoms. At the molecular level, colchicine works by reducing inflammation, which can help improve blood flow in the small vessels of the heart. It is classified pharmacologically as an anti-inflammatory medication.

Investigated diseases

Coronary Microvascular Disease – Coronary Microvascular Disease (CMD) is a condition affecting the small blood vessels in the heart. Unlike larger coronary artery disease, CMD involves the tiny arteries that branch off from the larger coronary arteries. These small vessels can become damaged or dysfunctional, leading to reduced blood flow to the heart muscle. The disease progresses as these microvessels fail to dilate properly, which can cause chest pain or angina, especially during physical exertion or stress. Over time, the impaired blood flow can lead to persistent symptoms and may affect heart function. CMD is often associated with other conditions like high blood pressure or diabetes, which can exacerbate the dysfunction of the microvessels.