All studies
Active not recruitingNAINTERVENTIONAL

Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study

This study, called PREDICT, is looking into how doctors can best guide treatments for blocked heart arteries. When you have narrowed arteries, often causing chest pain, doctors might use a procedure called PCI to open them up. Currently, doctors often rely on X-ray pictures (angiography) to see if the treatment was successful. This study wants to find out if using special blood flow measurements, taken right after the PCI procedure, can lead to better results for patients. They're hoping this might mean fewer issues later on and less chest pain compared to the usual method. It's a pilot study, meaning it's a first step to see if this new approach is promising.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
Laval University
Enrolment target
221
Start
10 Sep 2021
Estimated completion
01 Mar 2026

What is this study about?

When arteries in your heart become narrowed or blocked, it can lead to chest pain (angina) and more serious heart problems. Doctors often perform a procedure called PCI (Percutaneous Coronary Intervention), where they insert a tiny balloon and often a small mesh tube called a stent to open up the artery and improve blood flow. After this procedure, doctors need to make sure it was successful and that the blood is flowing well.

Currently, doctors usually check the success of the PCI by looking at 'angiography' images, which are special X-ray pictures of your heart arteries. However, there are also advanced tools that can measure the actual blood flow and pressure inside your arteries. These measurements, like 'Fractional Flow Reserve' (FFR), can give a clearer picture of how well the blood is circulating and if any narrowing is still affecting blood flow significantly.

This study, called PREDICT, wants to see if using these detailed blood flow measurements right after a PCI procedure can give patients better long-term results. The aim is to find out if this approach leads to fewer problems with the treated artery and less recurrence of chest pain, compared to simply relying on the standard X-ray images. It's an important step to help doctors improve how they ensure successful heart artery treatments.

Key takeaways

  • The PREDICT study compares two ways of checking heart artery treatment success.
  • One way uses standard X-ray pictures, the other uses detailed blood flow measurements.
  • The goal is to see if blood flow measurements lead to fewer problems and less chest pain later.
  • Participation involves extra measurements during your planned heart procedure.
  • This research aims to improve how doctors care for patients with narrowed heart arteries.

Who may be eligible?

This study is looking for adults aged 18 and over who are having tests for their heart arteries or are planned to have a procedure to open up a blocked artery. To be considered, your procedure to open the artery must be successful and straightforward, meaning the artery is well-opened with good blood flow, and without any immediate problems.

Generally, you won't be able to join the study if your blocked artery is in a specific type of graft from an earlier surgery. Also, if you have an allergy to common blood-thinning medications that you would need to take for at least 30 days after the procedure, you might not be suitable for this study. If your PCI procedure didn't quite go as planned, for example, if there was still significant narrowing or immediate complications, you wouldn't be able to take part. Finally, if you are having treatment for a very recent, serious heart attack (ST-Elevation MI), this study would not be right for you.

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. Are you having tests for blocked arteries or a procedure to open them?
  3. Have you had a successful and straightforward procedure to widen your artery?
  4. Are you able to take common blood-thinning medicines for at least 30 days?
  5. Have you not had a recent, very serious heart attack (ST-Elevation MI)?
Answer every question to see your result.

What does participation involve?

If you join this study, you will undergo a standard procedure to open your heart arteries (PCI). During this same procedure, after your artery has been stented, some additional measurements of blood flow and pressure will be taken using a special thin wire. There are no extra visits or medications specifically for this study. Doctors will then follow your health over time, just as they would normally, to see how you are doing. The total duration of your participation in terms of specific study activities would primarily be during your PCI procedure itself.

Potential risks and benefits

Taking part in this study could help doctors understand how to improve heart artery treatments, potentially leading to better outcomes for future patients. For you, the main benefit is contributing to this important knowledge. The study involves taking additional measurements during an already planned heart procedure; these measurements are generally safe and widely used in hospitals, so they are not expected to add significant new risks beyond your standard procedure. As with any clinical study, you are free to change your mind and withdraw at any time without affecting your medical care.

Locations (1)

  • IUCPQ - Laval Hospital
    Verified postcode
    Québec, Canada

Common questions

What is PCI?

PCI stands for Percutaneous Coronary Intervention, which is a procedure to open narrowed or blocked heart arteries, often using a small balloon and a stent.

What is angiography?

Angiography uses X-ray pictures to show your heart arteries and identify any blockages or narrowings.

What is FFR?

FFR (Fractional Flow Reserve) is a measurement that tells doctors how well blood is flowing through a heart artery, giving a clearer picture of any blockages.

Will I get extra medicine in this study?

No, this study does not involve giving you any extra medications beyond what your doctor would normally prescribe for your heart condition.

Will this study change my usual treatment?

No, you will receive the same standard treatment for your heart condition. This study is about how doctors assess the success of that treatment.

How to find out more

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

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