Active not recruitingOBSERVATIONAL

Pullback Pressure Gradient (PPG) Global Registry

This study is investigating a new measurement called the Pullback Pressure Gradient (PPG) index, which helps doctors understand blockages in the heart's arteries more clearly. It's for people with conditions like chronic coronary insufficiency and certain types of heart attacks. Currently, doctors use a method called Fractional Flow Reserve (FFR) to check blood flow. The PPG index adds more detailed information by showing if a blockage is tightly focused in one spot or spread out along the artery. This extra detail helps doctors make better decisions about whether to open up the artery with a procedure called PCI (stenting) and predicts how well that treatment might work. By making more informed choices, the study hopes to improve outcomes for patients with heart problems.

At a glance

Status

Active not recruiting

Sponsor

VZW Cardiovascular Research Center Aalst

Enrolment target

982

Start

23 Dec 2020

Estimated completion

31 Dec 2026

Chronic Coronary Insufficiency Non ST Elevation Myocardial Infarction

What is this study about?

Imagine your heart's arteries are like pipes. Sometimes, these pipes can get narrowed or blocked, which can lead to chest pain or even a heart attack. Doctors can measure how well blood flows through these pipes using a method called Fractional Flow Reserve (FFR). If the FFR shows that the blood flow isn't quite right (meaning it's 0.80 or less), it suggests there's a problem that might need fixing.

This study, called the Pullback Pressure Gradient (PPG) Global Registry, is looking at a new, more detailed way to understand these blockages. It uses something called the PPG index. Think of it like this: FFR tells you if there's a blockage, but the PPG index helps doctors understand *where* the blockage is most significant. Is it a short, sharp blockage, or is the narrowing spread out along a longer section of the pipe? This information is really important because it can help doctors decide if a procedure to open up the artery (called PCI, often involving a stent) is likely to be very effective.

The main goal of this study is to see how well the PPG index can predict the success of PCI and how it influences doctors' decisions about treatment. By using this new tool, doctors hope to make more precise treatment plans, leading to better results and improved heart health for patients.

Key takeaways

This study evaluates a new tool (PPG index) for heart artery blockages.
It aims to help doctors make better treatment choices for people with heart disease.
The PPG index tells doctors if a blockage is focused or spread out.
It could lead to more successful treatments like stenting (PCI).
Participation involves measurements during a standard heart procedure.

Who may be eligible?

This study is looking for adults aged 18 to 100 who have been diagnosed with certain heart conditions. You might be able to take part if you have stable coronary artery disease (a long-term narrowing of the heart arteries) or if you've recently had a specific type of heart attack and your condition is now stable. Importantly, a previous heart scan must have shown that the blood flow in your heart arteries, measured by something called FFR, is 0.80 or less.

However, there are reasons why you might not be able to join. For example, if the blocked part of your artery is right at the opening, or if your artery is very twisted, it might make the procedure too difficult. Also, if you have certain severe kidney problems, a specific type of heart attack (STEMI), or if your heart rhythm is very unstable, you wouldn't be able to participate. Doctors will also check if fixing a blockage requires a complex two-stent strategy in a branching artery or if it's too risky to re-insert the wires needed for the measurement.

The medical team will carefully review your health records and perform some tests to see if this study is right for you, ensuring your safety and that the study can gather accurate information.

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.

Are you aged 18 to 100?
Do you have stable coronary artery disease or a stable heart attack (not STEMI)?
Has a previous heart scan (FFR) shown blood flow equal to or less than 0.80?
Do you *not* have severe kidney disease (eGFR less than 30)?
Are your heart rhythms stable, and not an uncontrolled or recurrent fast beat?
Is your artery suitable for the procedure (not too twisted, not right at the opening)?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will undergo a standard procedure to assess your heart arteries, which includes a measurement called Fractional Flow Reserve (FFR) and a special 'pullback maneuver'. During this pullback, a thin wire is slowly drawn back through your artery while measurements are taken. This allows a new tool, the PPG index, to be calculated immediately. This calculation is performed using specialised software, which also helps correct for any small errors in the measurement. The results will be displayed on a screen for the doctors. There are no additional medications or extra visits specifically for this study beyond what would typically be part of your care. The duration of your participation will be limited to the time of this diagnostic procedure and follow-up as part of your normal medical care.

Potential risks and benefits

Participating in this study might offer the benefit of doctors having more detailed information about your heart's arteries, potentially leading to more personalised and effective treatment decisions. Doctors hope this new measurement will help them predict how well a procedure to open your arteries might work. As with any heart procedure involving a catheter, there are small risks, such as bleeding, infection, or very rarely, damage to the artery. The study uses measurements typically performed during standard care for certain heart conditions, so it doesn't introduce many new risks beyond what you would already be facing. You are free to withdraw from the study at any time without affecting your medical care.

Locations (23)

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

Stanford University
Verified postcode
Stanford, United States
St Francis Hospital and Heart Center
Verified postcode
New York, United States
Memorial Hermann Texas Medical Center
Verified postcode
Texas City, United States
Monash Medical Center
Verified postcode
Melbourne, Australia
Concord Repatriation General Hospital
Verified postcode
Sydney, Australia
OLV Aalst
Verified postcode
Aalst, Belgium
Aalborg University Hospital
Verified postcode
Aalborg, Denmark
Aarhus University Hospital
Verified postcode
Aarhus, Denmark
Righospitalet
Verified postcode
Copenhagen, Denmark
Institut Arnault Tzanck
Verified postcode
Nice, France
Ferrara University
Verified postcode
Ferrara, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Verified postcode
Rome, Italy

Common questions

What is the PPG index?

It's a new measurement that helps doctors understand if a blockage in your heart artery is focused in one spot or spread out along the artery, providing more detail than current tests.

Why is this study important for me?

It helps doctors make more informed decisions about treating your heart condition, aiming to pick the best treatment that has the highest chance of success for you.

Will I have to take new medicines for this study?

No, there are no new medicines specifically for this study. Your participation involves an assessment during a procedure you might already be having.

How long will I be in the study?

Your direct participation involves the time it takes for the assessment procedure. Any follow-up will be part of your usual medical care.

Can I still withdraw if I change my mind?

Yes, you can decide to stop participating at any time, and it will not affect the quality of your medical care.