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Active not recruitingNAINTERVENTIONAL

Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Trial

This study, called FAVOR III Europe, is looking at a new technique called Quantitative Flow Ratio (QFR) to assess blockages in the heart's arteries. Currently, doctors often use a method called Fractional Flow Reserve (FFR), which involves a special wire. QFR uses images from an angiogram to estimate the blockage's severity, avoiding the need for an extra wire and medication. Researchers want to find out if using QFR to decide treatment for people with chest pain (stable angina) and moderately blocked arteries leads to similar good results after one year, compared to the standard FFR method. This could make the assessment process easier and safer for patients.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
Aarhus University Hospital Skejby
Enrolment target
2,001
Start
06 Nov 2018
Estimated completion
31 Dec 2025

What is this study about?

Imagine your heart has pipes, called arteries, that carry blood. Sometimes these pipes can get narrowed, causing chest pain known as angina. Doctors need to check how serious these narrowings are to decide if you need treatment, like a stent.

Currently, one common way doctors check this is called Fractional Flow Reserve (FFR). It involves guiding a special tiny wire into your artery to measure pressure, and you also receive medicine to temporarily increase blood flow. While FFR is very good and widely recommended, it has a few steps that might be simplified.

This study is testing a newer method called Quantitative Flow Ratio (QFR). Instead of an extra wire measurement, QFR uses pictures already taken during a heart angiogram to work out how much a narrowing is affecting blood flow. The main goal of this study is to see if using this QFR approach to guide treatment decisions leads to the same good health outcomes for patients with chest pain and moderately narrowed arteries after one year, compared to the current FFR method. If it is, QFR could offer a simpler way to assess heart blockages.

Key takeaways

  • It compares two ways to check heart artery blockages: QFR (newer, image-based) vs. FFR (standard, wire-based).
  • Aims to see if QFR guides treatment decisions as safely and effectively as FFR.
  • Focuses on patients with stable chest pain and moderately narrowed heart arteries.
  • Participation involves your regular angiogram and a one-year follow-up.
  • Could lead to a simpler assessment method for heart conditions.

Who may be eligible?

This study is looking for adults aged 18 or older, both men and women, who are scheduled to have a heart angiogram. You might be suitable if you experience stable chest pain (angina) or if you're having a check-up for other blockages after a mild heart attack. You'll need to be able to understand the study and agree to take part in writing. Your heart arteries should have a narrowing between 40% and 90% and be at least 2.5 mm wide, and it's okay if you've had a narrowing return in a natural artery.

You cannot take part if you have very severe kidney problems, a life expectancy of less than a year, or are very unwell due to heart issues. Also, you're not eligible if you've had a certain type of heart attack very recently, have bypass grafts that are being studied, or certain heart rhythm problems. If you are pregnant, breastfeeding, planning to become pregnant, or have other specific heart conditions like very poor heart pumping ability, this study won't be right for you. It's also not suitable if you're allergic to the dye used in angiograms or can't take certain medications.

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 scheduled for a heart angiogram?
  3. Do you have stable chest pain (angina) or need secondary lesion assessment after certain heart events?
  4. Do your heart arteries have a blockage between 40% and 90%?
  5. Are you able to agree to take part in writing?
  6. Are you not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll still have your planned heart angiogram as usual. During this procedure, depending on which group you're in, your doctor will use either the standard FFR method (with the pressure wire) or the new QFR method (which uses the angiogram images) to assess your heart blockages. The treatment decisions for your narrowed arteries will then be guided by the results of that specific diagnostic method.

You will have follow-up evaluations to check on your health and any heart-related events over the course of one year. This will involve appointments where doctors will ask about your well-being and might do some routine checks. The total duration of your active participation in the study, including all follow-ups, will be 12 months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from careful monitoring of your heart condition. However, there are small risks associated with any medical procedure, including the angiogram itself and the methods used to assess your arteries. The study is comparing two established ways of assessing heart blockages for safety and effectiveness. Importantly, you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (35)

  • Aalborg University Hospital
    Verified postcode
    Aalborg, Denmark
  • Aarhus University Hospital
    Verified postcode
    Aarhus N, Denmark
  • Gentofte Hospital
    Verified postcode
    Hellerup, Denmark
  • Institut Arnault Tzanck
    Verified postcode
    Saint-Laurent-du-Var, France
  • GCS ES Axium - Parc Rambot
    Verified postcode
    Aix-en-Provence, France
  • CHU de Lille, Lille University Hospital
    Verified postcode
    Lille, France
  • Institut Cardiovasculaire Paris Sud (ICPS), Hopital Jacques Cartier
    Verified postcode
    Massy, France
  • Hopital Haut-Leveque, Pessac
    Verified postcode
    Pessac, France
  • Hôpital Privé Claude Galien
    Verified postcode
    Quincy, France
  • Clinique Pasteur, Toulouse
    Verified postcode
    Toulouse, France
  • Charite-Universitatsmedizin Berlin
    Verified postcode
    Berlin, Germany
  • Elisabeth Krankenhaus
    Verified postcode
    Essen, Germany

Common questions

What is an angiogram?

An angiogram is a special X-ray test where doctors inject a dye into your blood vessels to see if they are blocked or narrowed.

What is 'stable angina'?

Stable angina is chest pain or discomfort that happens predictably, usually during physical activity or stress, and goes away with rest or medication.

Will I know which treatment pathway I'm on?

You and your doctor will discuss which diagnostic method will be used to guide your treatment decisions in the study.

What does a 'non-inferior' result mean?

It means the new method (QFR) is expected to be as good as the standard method (FFR) in terms of patient outcomes, not necessarily better, but not worse.

Who is funding this study?

The information provided doesn't explicitly state the funding source for this trial.

How to find out more

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

Discussion

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