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RecruitingNot ApplicableInterventional

Using light-based imaging to make heart stent treatment safer and more effective

This study is about improving how doctors treat heart attacks. When someone has a heart attack, doctors often use X-ray pictures (angiography) to guide tiny tubes, called stents, into blood vessels to open them up. These X-rays can sometimes be blurry. A newer scan, called OCT (optical coherence tomography), takes much clearer pictures from inside the blood vessels. This research aims to find out if using OCT to guide treatment leads to better results for people who have had a heart attack, compared to using the standard X-ray method. Participants will be randomly placed into one of two groups and followed for a year. The study hopes to make heart attack treatment more effective and safer for future patients.

At a glance

Status
Recruiting
Phase
Not Applicable
Sponsor
Aarhus University Hospital
Enrolment target
3,000
Start
10 Nov 2025
Estimated completion
01 Nov 2027

What is this study about?

This research is looking for better ways to treat heart attacks. When you have a heart attack, it means blood flow to part of your heart is blocked. Doctors often fix this by putting a small tube, called a stent, into the narrowed blood vessel to hold it open. To guide this procedure, they usually use X-ray pictures called angiography. While angiography is very helpful, the images can sometimes be hard to see clearly.

There's a newer imagining technique called OCT, or Optical Coherence Tomography. Think of it like a tiny camera that goes inside your blood vessel and gives doctors a much more detailed, 3D picture. This study wants to find out if using these very clear OCT images to guide the stent placement will lead to better results for patients who have had a heart attack, compared to the standard X-ray guidance.

The main goal is to see if using OCT can make the treatment safer and more successful in the long run. By comparing these two methods, the researchers hope to learn how to best treat people who have had a heart attack, helping them to recover better and have fewer problems in the future.

Key takeaways

  • The study compares a new imaging method (OCT) with standard X-rays (angiography) for heart attack treatment.
  • It aims to see if OCT helps doctors place stents more effectively.
  • Participants will get standard heart attack care, guided by either OCT or X-rays.
  • The study involves a one-year follow-up to check on your health.
  • Participation may help improve future heart attack treatments.
  • Your medical care will not be affected if you choose not to join or decide to leave the study.

Who may be eligible?

This study is designed for adults aged 18 or older who come to the hospital with a heart attack. This includes both severe heart attacks (STEMI) and less severe ones (NSTEMI) that started fairly recently – within 12 hours for STEMI or 48 hours for NSTEMI.

There are also some reasons why you might not be able to join. For instance, if you are very unwell, such as being in shock or having serious kidney problems. Also, if you have certain existing heart conditions, such as severe heart failure, or if you can't lie flat for a period of time, you might not be suitable for this study.

It's important that you are able to understand what the study involves and give your permission to take part. If you have any allergies to common medications like aspirin or the dye used in these procedures, or if doctors think you won't be able to keep up with the follow-up appointments, you might not be able to participate.

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 (within 12 hours for STEMI or 48 hours for NSTEMI)?
  3. Are you generally well enough to undergo a heart procedure?
  4. Can you understand the study information and give your permission?
  5. Do you not have any severe kidney disease or very serious heart failure?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups, like flipping a coin. Both groups will get the standard care for their heart condition, including treatment to open up any blocked arteries. In one group, doctors will use the new OCT imaging to guide their work. In the other group, they will use the standard X-ray imaging (angiography) to guide the treatment.

During your hospital stay, doctors might also check other blood vessels that aren't causing immediate problems. After your initial treatment, you won't need extra hospital visits just for the study. Instead, the researchers will keep track of how you're doing for a full year using information from your regular medical follow-up appointments. There are no special medications involved in the study; you'll receive the treatments your doctor thinks are best for your condition.

Potential risks and benefits

Taking part in this study might help doctors learn more about the best way to treat heart attacks, which could benefit future patients. For you, the OCT imaging might offer a more precise treatment, but we don't yet know if it's actually better than the standard method. The risks involved are similar to those of any standard heart procedure, such as bleeding, allergic reactions to medications or dyes, or other complications that can sometimes happen during these treatments. 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.
  • Bournmouth
    City only
    Bournemouth, England

Common questions

What is a stent?

A stent is a tiny mesh tube that doctors place inside a narrowed or blocked blood vessel to help keep it open and improve blood flow to your heart.

What does 'imaging' mean?

Imaging refers to different ways doctors take pictures inside your body to see what's going on, like X-rays or the more detailed OCT scan mentioned in this study.

Will I know which group I'm in?

Yes, you will be told if you are in the group receiving OCT-guided treatment or the group receiving standard X-ray (angiography) guided treatment.

Who is paying for this study?

The study is receiving funding from a company called Abbott, based in Denmark.

Can I stop participating if I change my mind?

Yes, you have the right to withdraw from the study at any time, and this will not affect the quality of your medical care.

How to find out more

Helle Bargsteen

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

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