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iFR Guided Coronary Artery Bypass Grafting Surgery

This study is investigating if a special measurement (called iFR) taken inside your heart's arteries before bypass surgery can help surgeons choose the best places for the new bypasses. This is different from the usual way, which relies on looking at X-ray pictures of your arteries. The main goal is to see if using these iFR measurements leads to the bypasses staying open and working better for longer (12 months after surgery). This could help improve how well bypass surgery works. Doctors will also check your heart with scans after 3 months and 12 months, and you'll complete questionnaires about your quality of life.

At a glance

Status
Recruiting
Sponsor
Prakash Punjabi
Enrolment target
100
Start
25 Apr 2022
Estimated completion
31 Aug 2026

What is this study about?

When people have heart problems caused by blocked arteries, a common operation is coronary artery bypass grafting, often called CABG or bypass surgery. In this surgery, doctors take healthy blood vessels from another part of your body and use them to create new paths around your blocked heart arteries, allowing blood to flow more freely to your heart muscle.

Currently, surgeons usually decide which arteries need bypassing by carefully looking at X-ray pictures of your heart, called angiograms. These pictures show where the blockages are. However, this study is exploring a different approach. Before your bypass surgery, doctors will use a small wire with a sensor to measure the blood flow and pressure inside your heart arteries. This measurement is called iFR. It's a more precise way to understand how much a blockage is affecting blood flow, something that might not always be clear just from X-ray pictures. This iFR measurement is already used sometimes when doctors are fitting stents (small tubes to open up arteries), but it's not usually used to plan bypass surgery.

The main idea behind this study is to see if using these detailed iFR measurements to guide the bypass surgery leads to better long-term results. Specifically, they want to find out if the new bypass grafts stay open and work well for longer (at least 12 months) compared to the standard way. If this study shows good results, it could mean that using iFR measurements could become a new and even more effective way to plan bypass surgeries in the future, potentially leading to better outcomes for patients.

Key takeaways

  • This study explores a new way to pick the best spots for bypass grafts.
  • It uses special 'iFR' measurements from inside your heart arteries.
  • The goal is to see if this leads to bypasses staying open longer.
  • You'll have scans and complete questionnaires over 12 months.
  • Participation involves no extra medical risks beyond standard care.
  • This research could help improve future heart bypass surgeries.

Who may be eligible?

To be part of this study, you would generally need to be between 25 and 80 years old and planning to have your first elective (planned, not emergency) heart bypass surgery. It's important that you understand and are happy to sign a consent form before your surgery.

Also, your doctors will need to have already taken those special iFR measurements during your pre-operative heart X-ray (angiogram). This study is for people who have several blocked heart arteries and are already scheduled for bypass surgery.

However, you wouldn't be able to join if you need emergency bypass surgery, or if your heart has a very low pumping ability (measured as an Ejection Fraction of 40% or less), or if you have severe problems with your heart valves.

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. Am I aged between 25 and 80?
  2. Am I having my first planned heart bypass surgery?
  3. Have I already had iFR measurements taken during my heart angiogram?
  4. Do I understand what the study is about and am I willing to sign a consent form?
  5. Do I need emergency surgery (if yes, I can't join)?
  6. Do I have a very weak heart or severe heart valve problems (if yes, I can't join)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll still have your planned bypass surgery as usual. Before your surgery, some special measurements called iFR would have already been taken during your routine heart X-ray. After your surgery, the study team will follow your progress.

You'll have an ultrasound scan of your heart (echocardiography) about 3 months after your surgery. Then, around 12 months after surgery, you'll have a special CT scan (CT Coronary Angiography) to check how well your bypass grafts are working. At both the 3-month and 12-month check-ups, you'll also be asked to fill out a questionnaire about your quality of life. You'll continue to take any medications prescribed by your doctor throughout the study. The total study follow-up period will last for 12 months after your surgery.

Potential risks and benefits

Taking part in this study means your doctors might gather more detailed information about your heart's arteries before your surgery. This could potentially help improve the long-term success of your bypass grafts, although this is what the study aims to find out. There are no additional medical procedures or risks beyond what you would normally have as part of your standard care or follow-up after bypass surgery. All participants will continue to receive the best medical care. 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.
  • Imperial College Healthcare NHS Trust - Hammersmith Hospital
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is iFR?

iFR stands for 'instantaneous wave-free ratio'. It's a precise measurement taken inside your heart arteries to see how much a blockage is affecting blood flow.

Is this a new type of surgery?

No, it's not a new surgery itself. It's looking at whether using extra measurements (iFR) before the standard bypass surgery can help guide the surgeon better.

Will I get extra treatments if I join?

No, you will receive the standard excellent medical care you would normally get for heart bypass surgery. The study is about how doctors decide where to place the new bypasses.

What scans will I have?

You'll have a heart ultrasound (echocardiography) after 3 months and a special CT scan (CTCA) after 12 months to check your bypasses, which are part of the study follow-up.

How long does the study last for me?

You'll be followed for 12 months after your bypass surgery, with check-ups and scans at 3 and 12 months.

How to find out more

Prakash P Punjabi, MBBS,MCh,FRCS,FFST,FESC,FCCP

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

Interested in taking part?

Register your interest

Share your details and the research team for "iFR Guided Coronary Artery Bypass Grafting Surgery…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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