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Active not recruitingOBSERVATIONAL

Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations (PHYCO)

This research is looking into how doctors assess blockages in the heart's arteries, especially when they are partly blocked (between 50% and 70%). Currently, a common test called Fractional Flow Reserve (FFR) is used. While useful, FFR sometimes misses certain details about how blood flows and how the tiny blood vessels in the heart are working. The study, called PHYCO, wants to understand how different situations affect blood flow and how well FFR works. Over time, this could lead to better ways of diagnosing heart conditions and more personalised treatment plans for people with partially blocked arteries. It aims to improve our understanding of heart health and help doctors make the best decisions for their patients.

At a glance

Status
Active not recruiting
Sponsor
University Hospital, Brest
Enrolment target
400
Start
13 Jul 2023
Estimated completion
01 Apr 2027

What is this study about?

Imagine your heart has its own network of tiny pipes, called arteries, that deliver blood. Sometimes, these pipes can get a bit clogged, known as coronary artery disease. When a pipe is only partly clogged – not completely shut, but narrowed by about 50% to 70% – doctors often need more information to decide if treatment is needed.

Currently, a common test called Fractional Flow Reserve (FFR) is used. It helps doctors work out how well blood is flowing through the narrowed part of the artery. However, FFR mainly looks at pressure changes and doesn't always fully consider how the tiniest blood vessels in your heart are working, or how different situations might change blood flow. This study, PHYCO, wants to get a more complete picture of how these factors affect your heart.

The main goal of this research is to see how different things can impact blood flow and how these might affect the results of the FFR test. By understanding this better, we hope to find new and improved ways to diagnose heart problems and offer more tailored treatment plans for each person. This means if you have a partially blocked artery, doctors could potentially use this new knowledge to decide on the best course of action specifically for you.

Key takeaways

  • The study aims to improve heart artery diagnosis.
  • It focuses on improving a test called FFR for partial blockages.
  • Learning more about blood flow will lead to personalised treatments.
  • Participation is for adults aged 18-100 with specific artery blockages.
  • Certain health conditions would prevent you from joining the study.
  • Your involvement could help improve future heart care for many.

Who may be eligible?

This study is looking for people aged 18 to 100 years old, regardless of whether they are male or female. The main requirement for joining is that you have a heart artery that is partly blocked, specifically between 50% and 70%. Your doctor would be able to confirm whether you meet this specific criteria.

However, there are certain health conditions that mean you wouldn't be able to take part. For example, if your heart is very unstable, or if you have specific allergies, like to a medication called adenosine, you wouldn't be eligible. Also, if you have severe breathing problems like asthma or COPD, or certain heart rhythm issues, you wouldn't be able to join.

Other reasons for not being able to join include if you are pregnant, or have significant narrowing in your neck arteries. The study team and your doctor will carefully go through all these details with you to make sure it's safe and appropriate for you 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 between 18 and 100 years old?
  2. Do you have an heart artery blockage that is between 50% and 70%?
  3. Are you generally stable, and not experiencing severe heart symptoms?
  4. Do you have any serious lung conditions like severe asthma or COPD?
  5. Are you pregnant or might you be pregnant?
  6. Do you have any severe allergies to medicines like adenosine?
Answer every question to see your result.

What does participation involve?

The specific details of what taking part involves are not fully described here. However, it is a research study focused on improving how doctors assess heart artery blockages. This likely means you would undergo some extra tests related to your heart and blood flow beyond what you might usually have. These tests would involve looking at how your blood moves through your heart and how your heart structures are working under specific conditions.

You would probably have hospital visits, and these assessments would be done by medical professionals. The study aims to gather detailed information, so there might be repeat measurements or specific procedures to understand the changes over time. Any medication or procedures involved would be carefully explained to you by the research team.

The total duration of your involvement in the study, including how many visits or how long the tests would take, would be clearly outlined by the study doctors before you decide to take part. You would be given a chance to ask all your questions.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is that it helps improve our understanding of heart conditions and could lead to better and more personalised ways of diagnosing and treating people with partially blocked heart arteries in the future. While there might not be a direct benefit to you personally, your participation could help many others. Potential risks are generally associated with the tests and procedures involved, which the study team will explain in detail. These risks could include discomfort from the tests, or very rare complications, though every effort is made to ensure your safety. Remember, participation is voluntary, and you are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

  • Chu Brest
    Verified postcode
    Brest, France

Common questions

What is coronary artery disease?

It's a common heart condition where the main blood vessels that supply the heart become partly blocked or hardened, making it harder for blood to flow.

What does FFR stand for?

FFR stands for Fractional Flow Reserve. It's a test doctors use to measure blood flow and pressure in heart arteries to see if a blockage is serious enough to need treatment.

Why is this research important?

This research aims to improve how doctors diagnose and treat heart artery blockages, potentially leading to more accurate diagnoses and personalised care for patients.

Will taking part help me directly?

While research often helps many people in the future, it's not guaranteed to directly help you. However, the information gathered from your involvement will be very valuable.

Is the study suitable for everyone?

No, there are certain health conditions or situations that would prevent someone from joining, such as severe asthma, unstable heart conditions, or pregnancy. The study team will check if it's right for you.

How to find out more

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

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