Colchicine Assessment of Low-grade Inflammation and Biomarker Response in Atherosclerosis with Targeted Evaluation
This study, called 'Colchicine Assessment of Low-grade Inflammation and Biomarker Response in Atherosclerosis with Targeted Evaluation' (CALIBERATE), is investigating if a medicine called colchicine can help people with certain types of heart disease, such as ischemic heart disease or coronary artery disease. These conditions often involve inflammation in the blood vessels, which can make heart problems worse. The researchers want to see if colchicine can reduce this inflammation. They will be using special scans of the neck arteries (carotid arteries) to measure any changes in inflammation over six months. Some participants will receive colchicine, while others will receive a placebo (a dummy pill), to compare the effects fairly. This is a Phase IV study, meaning the medicine is already approved for other uses.
At a glance
What is this study about?
Imagine your blood vessels as pipes carrying blood around your body. Sometimes, these pipes can get inflamed, especially in people with heart conditions like coronary artery disease. This inflammation can contribute to blockages and other problems.
This study is trying to find out if a commonly used medicine called colchicine can help calm down this inflammation in the blood vessels. Colchicine is already used for other health issues, but researchers want to see if it can also help people with heart disease by reducing inflammation. Think of it like trying to cool down a hot spot in the 'pipes' of your body.
To see if colchicine works, the researchers will take special pictures, almost like advanced X-rays, of the blood vessels in your neck (called carotid arteries). They will do these scans at the beginning and again after six months to check if the level of inflammation has changed. Half the people in the study will get colchicine, and the other half will get a dummy pill (placebo). This way, the researchers can fairly compare if colchicine makes a real difference in reducing inflammation.
Key takeaways
- The study explores if colchicine can reduce inflammation in blood vessels for heart conditions.
- It uses special scans to measure inflammation in neck arteries over six months.
- Participants will receive either colchicine or a placebo (dummy pill).
- It's open to adults aged 18+ with certain heart diseases.
- Your participation could help improve future treatments for heart disease.
Who may be eligible?
This study is open to adults aged 18 and over, with no upper age limit. Both men and women can take part.
You might be suitable for this study if you have been diagnosed with certain heart conditions that affect the blood vessels, such as ischemic heart disease, coronary artery disease, or chronic coronary artery syndrome. These are all conditions where the blood vessels supplying the heart can become narrowed or hardened, often due to inflammation.
More detailed checks will be done by the study team to make sure it's safe and appropriate for you to participate, as there might be specific health aspects or other medications that could affect your ability to join. They will explain everything clearly.
- Are you 18 years old or older?
- Do you have a diagnosis of ischemic heart disease, coronary artery disease, or chronic coronary artery syndrome?
- Are you willing to take a study medication for six months?
- Are you able to attend clinic visits and have special scans?
- Are you prepared to potentially receive a placebo instead of the active drug?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be randomly assigned to either receive the study medicine (colchicine) or a placebo (a dummy pill). You won't know which one you're taking, and neither will your study doctor, to ensure fairness in the results. You will take the assigned medication for six months.
During these six months, you will have a few visits to the clinic. At the beginning, you'll have a thorough check-up, including some blood tests and a special scan of your neck arteries called a PET/CT scan. This scan helps measure the inflammation in your blood vessels. You'll then continue taking your medication, and after six months, you'll have another check-up and another PET/CT scan to see if there have been any changes in the inflammation. There will also be some follow-up calls or visits to monitor your health throughout the study.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What is colchicine used for normally?
Colchicine is typically used to treat conditions like gout, which is a type of arthritis, and also some other inflammatory conditions.
What is a placebo?
A placebo is a 'dummy pill' that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the actual medicine fairly.
What is a PET/CT scan?
It's a special type of scan that combines two imaging methods to create detailed pictures inside your body. For this study, it helps measure inflammation in your blood vessels.
Will I know if I'm getting the real medicine?
No, neither you nor your study doctor will know whether you are receiving colchicine or the placebo. This is called 'blinding' and helps ensure the study results are unbiased.
How long will I be in the study?
You will take the study medication for six months, and there will be follow-up appointments and scans during and after this period.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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