RecruitingNAINTERVENTIONAL

ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO

This study, called ISCHEMIA-CTO, is for people with heart disease where a main artery to the heart is completely blocked, known as a Chronic Total Occlusion (CTO). Researchers want to find out if a procedure to unblock this artery (PCI) is a better treatment than just using medicines. They're looking at two groups: one with few symptoms but significant heart muscle strain, and another with more noticeable symptoms. For the first group, they'll check if PCI reduces serious heart events over five years. For the second group, they'll see if PCI greatly improves their quality of life after six months. This will help doctors understand the best way to treat CTOs.

At a glance

Status

Recruiting

Phase

Sponsor

Aarhus University Hospital Skejby

Enrolment target

1,560

Start

06 Nov 2018

Estimated completion

01 Nov 2032

Ischemic Heart Disease Chronic Total Occlusion of Coronary Artery

What is this study about?

Imagine your heart is a house and the arteries are pipes bringing water. Sometimes, a pipe can get completely blocked, which doctors call a Chronic Total Occlusion (CTO). This means a part of your heart muscle might not be getting enough blood.

Doctors aren't entirely sure whether it's always best to try and unblock these pipes using a procedure (like putting in a small tube called a stent) or if it's better to manage the problem with medicines alone. This study was designed to help answer that question. It compares the procedure, called Percutaneous Coronary Intervention (PCI), with using the best possible medicines.

The study looks at people in two main groups. One group has a CTO but doesn't have many symptoms, though tests show their heart muscle is struggling. For them, the study wants to see if unblocking the artery prevents serious health problems like heart attacks or strokes in the long run. The other group has more noticeable symptoms, and for them, the study aims to find out if unblocking the artery improves their daily life and how they feel.

Key takeaways

This study compares unblocking heart arteries (PCI) with medicine for CTOs.
It aims to see if PCI improves major health outcomes or quality of life.
Participation involves initial medical therapy, then random assignment to PCI or continued medicine.
Follow-up can last from six months to five years, depending on your group.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you would need to have a completely blocked heart artery (CTO) and tests must show that your heart muscle isn't getting enough blood to the area. You also need to be at least 18 years old and willing to attend follow-up appointments.

There are some reasons you wouldn't be able to join. For example, if you've recently had a heart attack, if your heart arteries aren't suitable for the unblocking procedure, if your doctors think another surgery would be better, or if you have other serious health problems that shorten your life expectancy, like very severe lung disease. Also, if you're pregnant or have severe kidney problems, you wouldn't be able to take part.

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.

Do I have a completely blocked heart artery (CTO)?
Do tests show my heart muscle isn't getting enough blood because of the CTO?
Am I at least 18 years old?
Am I willing to come to follow-up visits?
Have I recently had a heart attack (within the last month)? (If yes, you might not be eligible)

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first be given the best possible medical treatment for three months. After this, you'll be randomly assigned to one of two groups: either you'll have the procedure to unblock your artery (PCI), or you'll continue with just your medicines. This decision is made by chance, like flipping a coin.

During the study, you'll have regular check-ups and answer questions about how you're feeling and your quality of life. If you're in the group with fewer symptoms, your follow-up will last for five years. If you're in the group with more symptoms, your follow-up will be for six months. The total duration of your involvement could be several months to five years, depending on which group you are in.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving very close medical attention and the most up-to-date treatments. However, there are also potential risks linked to the unblocking procedure, like bleeding, infection, or issues with the heart. The study aims to compare these risks and benefits against just using medicines. Remember, you can choose to stop being part of the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

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

Aarhus University Hospital
Verified postcode
Aarhus N, Denmark· Recruiting
Rigshospitalet
Verified postcode
Copenhagen, Denmark· Recruiting
Gentofte Hospital
Verified postcode
Hellerup, Denmark· Recruiting
Odense University Hospital
Verified postcode
Odense, Denmark· Recruiting
Zealand University Hospital
Verified postcode
Roskilde, Denmark· Recruiting
North-Estonia Medical Centre
Verified postcode
Tallinn, Estonia· Recruiting
Helsinki University Central Hospital
Verified postcode
Helsinki, Finland· Active not recruiting
Kuopio University Hospital
Verified postcode
Kuopio, Finland· Active not recruiting
Heart Hospital Tampere
Verified postcode
Tampere, Finland· Recruiting
Turku University Hospital
Verified postcode
Turku, Finland· Recruiting
Clinique Louis Pasteur
Verified postcode
Essey-lès-Nancy, France· Active not recruiting
Cardiovascular Institute, Groupe Hospitalier Mutualiste
Verified postcode
Grenoble, France· Recruiting

Common questions

What is a CTO?

A CTO stands for Chronic Total Occlusion. It means one of the main arteries that supplies blood to your heart has become completely blocked for a long time.

What is PCI?

PCI, or Percutaneous Coronary Intervention, is a procedure where doctors use a tiny balloon and sometimes a small tube called a stent to open up blocked heart arteries.

What does 'optimal medical therapy' mean?

This means receiving the best available medicines and lifestyle advice to manage your heart condition without needing a procedure to unblock the artery.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study meaning both you and your doctors will know if you are having the PCI procedure or are continuing with medicines.

What is 'ischemia'?

Ischemia means that a part of your heart muscle isn't getting enough oxygen-rich blood, which can cause symptoms or put a strain on your heart.

How to find out more

Evald Christiansen, MD PhD

evald.christiansen@dadlnet.dk +45 78452028 Official trial record

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