AuthorisedTherapeutic exploratory (Phase II)Interventional

Phase II: 68Ga-NODAGA-E[c(RGDyK)]2 Angiogenese PET for imaging angiogenesis in ischemic heart disease

This study is for people with long-term heart problems due to narrowed arteries, known as ischemic heart disease. We want to understand how the heart forms new blood vessels after a typical heart procedure to open up blocked arteries. This process is called angiogenesis. We use a special type of scan, called a PET scan, before and after your heart procedure to see these new blood vessels forming. We also look at how much blood flows to your heart and if your heart muscle recovers and works better afterwards. The aim is to see if growing new blood vessels can help the heart heal and improve its function, ultimately helping doctors find better ways to treat heart disease.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Rigshospitalet

Enrolment target

Start

08 Jan 2025

Chronic ischemic heart disease

What is this study about?

This research study is looking at a common heart condition called chronic ischemic heart disease. This happens when the blood vessels supplying your heart become narrowed, reducing blood flow and leading to problems like chest pain. To help with this, doctors often perform procedures to open up these blocked arteries, allowing more blood to reach the heart muscle.

After these procedures, your body naturally tries to repair the heart. One way it does this is by growing new tiny blood vessels – a process called angiogenesis. This study uses a special scanning technique, called a PET scan, to see and measure how much your heart is growing these new blood vessels. We perform these scans before and after your heart procedure.

The main goal is to understand if there's a connection between how many new blood vessels grow and how well your heart recovers and functions afterwards. By learning more about this process, we hope to find better ways to help people with heart disease heal and improve their quality of life. This research is in an early stage (Phase II), meaning we are exploring and gathering important information.

Key takeaways

The study uses special scans to understand how hearts heal after treatment.
It's for people with long-term heart problems due to blocked arteries.
The goal is to see if growing new blood vessels helps the heart recover.
Participation involves PET scans before and after a heart procedure, plus follow-up.
Your regular heart treatment is not affected by taking part.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Beyond these basic requirements, there will be specific health criteria that the study doctors will go through with you. For example, you would typically need to have been diagnosed with a type of long-term heart condition where your heart isn't getting enough blood, known as chronic ischemic heart disease.

The research team will carry out several checks to make sure the study is a good fit for you and that it's safe for you to take part. This will involve reviewing your medical history and possibly conducting some tests.

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?
Have you been diagnosed with chronic ischemic heart disease?
Are you scheduled for a procedure to open up blocked heart arteries?
Are you able to attend appointments for scans and follow-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a special scan, called a PET scan, before your planned heart procedure to open up blocked arteries. After your procedure, you would have another PET scan to see how your heart has changed. You might also have other types of scans, like an 82Rb-PET scan to check blood flow and an 18F-FDG-PET scan to look at heart muscle recovery and damage. These scans usually involve a small injection of a safe, temporary tracing substance. There will also be follow-up checks over several weeks to see how you are recovering and how your heart is functioning. The total duration of your participation would involve these scans and follow-up assessments.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is that it helps us learn more about how the heart heals, which could lead to better treatments for heart disease in the future. You may also get extra monitoring of your heart health. Potential risks might include discomfort from the injections for the scans, or very rare reactions to the tracing substances used in the PET scans. The research team will explain all known risks in detail. Remember, your participation is voluntary, and you are free to withdraw from the study at any time without 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 is 'ischemic heart disease'?

It's a long-term heart problem where your heart muscle isn't getting enough oxygen-rich blood because the arteries supplying it are narrowed.

What is a 'PET scan'?

A PET scan is a special type of imaging test that uses a small amount of a safe, short-lasting tracer to show how organs and tissues are working at a cellular level.

What is 'revascularisation'?

This is a medical procedure, like a stent or bypass surgery, to restore normal blood flow to an organ, in this case, your heart.

Will I get the study drug?

In this study, the 'intervention' is a tracing substance used in the PET scan to help doctors see the new blood vessels, rather than a treatment drug itself.

How long will I be in the study?

Your participation will involve scans before and after your heart procedure, with follow-up checks over several weeks, typically lasting 6-8 weeks in total.