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Enrolling by invitationNAINTERVENTIONAL

Optical Coherence Tomography in Acute Vessel Evaluation

This study is looking at the best way to treat people who are having a heart attack, also known as acute coronary syndrome (ACS). When you have a heart attack, doctors often need to clear blockages in your heart's arteries. They can use a procedure called PCI, which involves tiny balloons and stents. Usually, doctors guide this procedure using special X-ray scans. However, this study will compare that standard method with a newer one that uses a tiny camera called Optical Coherence Tomography (OCT). The OCT camera gives a very detailed view inside your arteries. The main goal is to find out if using this detailed OCT camera helps patients recover better over one year compared to the standard X-ray guidance.

At a glance

Status
Enrolling by invitation
Phase
NA
Sponsor
Aarhus University Hospital Skejby
Enrolment target
3,000
Start
23 Nov 2025
Estimated completion
01 Sep 2039

What is this study about?

When someone has a heart attack, it's because a blood vessel in their heart has become blocked. Doctors need to open this blockage quickly to save heart muscle. This is usually done with a procedure called PCI, where they put a small tube into the artery and often place a tiny mesh tube (called a stent) to keep it open. Traditionally, doctors use a special type of X-ray, called an angiogram, to see where the blockages are and guide their work.

However, sometimes these X-rays don't give a perfectly clear picture, making it hard to see all the details of the blockage or how well the stent has been placed. This study is investigating whether using a more advanced camera, called Optical Coherence Tomography (OCT), can help. OCT is like a very tiny camera that gives a super-detailed image from inside the artery. The idea is that with this clearer view, doctors might be able to do an even better job of identifying and treating the problem areas.

The main aim of this research is to see if guiding the PCI procedure with OCT leads to better health outcomes for patients over the first year after their heart attack, compared to the standard X-ray guidance alone. We want to find out if having a more detailed view helps reduce problems like having another heart attack, stroke, or even death, in the long run.

Key takeaways

  • This study compares two ways to guide heart attack treatment: standard X-rays vs. a special detailed camera (OCT).
  • Its main goal is to see if OCT guidance leads to better patient outcomes over one year.
  • Participation involves either standard X-ray guided PCI or OCT-guided PCI, followed by a year of monitoring.
  • You would be at least 18 years old and recently had a specific type of heart attack to be eligible.
  • The study helps us learn how to improve care for people with heart attacks.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have recently experienced a specific type of heart attack (NSTEMI or STEMI) with symptoms that started within a certain timeframe. Doctors would also need to see signs of a blockage in your heart's arteries with an X-ray scan that can be safely treated during the procedure.

There are some reasons why you might not be able to join. For example, if you are very unwell with other serious heart conditions like severe heart failure or very low blood pressure, or if you have severe kidney problems. You also couldn't take part if you have certain allergies to medicines used in the procedure, or if doctors think it would be unsafe to place a camera inside your artery due to the specific shape or location of the blockage. It's also important that you would be able to lie flat for the procedure and attend follow-up appointments.

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.

  1. Are you 18 years old or older?
  2. Have you recently had a heart attack (NSTEMI or STEMI)?
  3. Are you able to provide written consent to join the study?
  4. Do you have suitable blockages in your heart arteries that can be treated during the procedure?
  5. Do you have any severe kidney problems or uncontrolled serious heart conditions?
  6. Are you able to lie flat for the procedure and attend follow-up appointments for a year?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two groups, like flipping a coin. One group will have their heart procedure guided by the standard X-ray method, and the other group will have it guided by the special OCT camera. Both procedures are standard treatments for heart attacks. Your doctors will perform the procedure as usual, but for those in the OCT group, they will also use the tiny OCT camera to get a detailed view of your arteries during the procedure itself. We would then monitor your health closely for one year, to see how you are doing. This will likely involve some follow-up appointments and may include checks of your heart and general health. The total duration of your active involvement in the study would be about one year.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as it could lead to a better understanding of how to treat heart attacks more effectively, which might benefit you and future patients. You would receive excellent medical care as part of both groups. However, like any medical procedure, there are potential risks involved with PCI itself, and using the OCT camera carries a small additional risk, such as a very slight chance of irritating the artery wall. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (19)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Leuven University Hospital
    Verified postcode
    Leuven, Belgium
  • Aalborg University Hospital
    Verified postcode
    Aalborg, Denmark
  • Aarhus University Hospital Skejby
    Verified postcode
    Aarhus N, Denmark
  • Rigshospitalet
    Verified postcode
    København Ø, Denmark
  • Odense University Hospital
    Verified postcode
    Odense, Denmark
  • Zealand University Hospital, Roskilde Sygehus
    Verified postcode
    Roskilde, Denmark
  • North-Estonia Medical Centre
    Verified postcode
    Tallinn, Estonia
  • North Karelia Central Hospital
    Verified postcode
    Joensuu, Finland
  • Vivantes Klinikum im Friedrichshain
    Verified postcode
    Berlin, Germany
  • Universitätsklinikum Schleswig-Holstein Campus Kiel
    Verified postcode
    Kiel, Germany
  • Turin Nord Emergency Hospital
    Verified postcode
    Turin, Italy
  • Latvia Centre of Cardiology
    Verified postcode
    Riga, Latvia

Common questions

What is a heart attack (ACS)?

A heart attack happens when blood flow to part of the heart is blocked, often by a blood clot. This can damage heart muscle.

What is PCI?

PCI stands for Percutaneous Coronary Intervention. It's a procedure where doctors use a small balloon and sometimes a stent to open blocked heart arteries.

What is OCT?

OCT (Optical Coherence Tomography) is a special tiny camera that doctors can use inside your arteries to get very detailed pictures of any blockages.

Will I know which group I'm in?

Yes, this is an 'open label' study, meaning both you and your doctors will know if you are in the standard X-ray group or the OCT camera group.

What happens after the procedure?

After your procedure, your medical team will continue to look after you. We'll then monitor your health and recovery for about one year, which involves some follow-up checks.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Optical Coherence Tomography in Acute Vessel Evaluation…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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