RecruitingOBSERVATIONAL

Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis

This study investigates two routine heart tests, FFR and iFR, in people who have severe aortic stenosis, a condition where the main heart valve doesn't open properly. Many people with aortic stenosis also have blocked arteries, called coronary artery disease (CAD), which can cause similar symptoms like chest pain. However, aortic stenosis can affect how accurate standard heart tests are. This research aims to compare the results of FFR and iFR with those from a more advanced heart scan called a PET scan. The goal is to determine if FFR and iFR can reliably detect narrowed arteries in patients with severe aortic stenosis, helping doctors make the best treatment decisions.

At a glance

Status

Recruiting

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Enrolment target

Start

01 Jun 2021

Estimated completion

30 Sep 2025

Aortic Valve Stenosis Coronary Artery Disease

What is this study about?

You've been invited to learn about a research study looking into how we diagnose certain heart problems. This study focuses on two common heart conditions: severe aortic stenosis (AS) and coronary artery disease (CAD).

Aortic stenosis is when your heart's main valve, the aortic valve, doesn't open fully. This can make your heart work harder and lead to symptoms like chest pain or breathlessness. Many people with severe aortic stenosis also have coronary artery disease, which means the blood vessels supplying blood to the heart muscle are narrowed or blocked. Both conditions can cause similar symptoms, making it tricky for doctors to figure out which problem is causing them.

Doctors use special tests to check for narrowed arteries. Two common tests are called FFR and iFR. However, in people with severe aortic stenosis, the heart works differently, and this might affect how accurate these FFR and iFR tests are. This study will compare the results of these tests (FFR and iFR) with a more detailed heart scan called a PET scan. The information from this study will help doctors understand if FFR and iFR are reliable tools for finding narrowed arteries in people who also have severe aortic stenosis, ensuring they get the right treatments.

Key takeaways

This study compares two heart tests (FFR and iFR) with a PET scan.
It focuses on people with severe aortic stenosis, a heart valve problem.
The goal is to see if FFR and iFR accurately find blocked heart arteries in these patients.
Your participation could help improve future diagnoses for heart conditions.
You must be aged 65 or over to potentially take part.

Who may be eligible?

This study is looking for volunteers who are at least 65 years old. You might be able to take part if you have severe aortic stenosis and are being considered for a procedure to replace your aortic valve.

Your heart should be pumping blood well, specifically, your heart's pumping strength (measured as 'ejection fraction') needs to be above 55%. Also, you shouldn't have any serious heart rhythm problems like a very slow heartbeat, and you need to be able to tolerate a common medication called Adenosine, which is sometimes used during heart tests.

However, you won't be able to join if you can't tolerate Adenosine, or if your heart's pumping strength is below 55%. If you're not sure if these apply to you, please discuss it with your doctor.

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 65 years old or older?
Do you have severe aortic stenosis and are being considered for valve replacement?
Is your heart's pumping strength (ejection fraction) above 55%?
Have you been told you have no issues with drugs like Adenosine?
Do you have some narrowing in your heart's arteries that isn't considered severe (FFR > 0.8)?

Answer every question to see your result.

What does participation involve?

The information provided does not fully detail the exact steps involved in participation, such as the total number of visits or the duration of involvement. However, based on the study's aim to compare different heart tests, it is likely that participants would undergo measurements for FFR and iFR, as well as a PET scan. These procedures involve medical appointments and imaging sessions. There is no mention of taking new or experimental medication as part of this study, but existing treatments would likely continue as advised by your doctor. You will be fully informed about all the specific appointments and tests required before you decide to take part.

Potential risks and benefits

Taking part in a research study has potential benefits and risks. There may not be a direct personal benefit to you from participating, but your involvement will help doctors better understand how to diagnose heart conditions in the future, ultimately helping others. Potential risks are generally associated with the standard medical procedures like FFR, iFR, and PET scans, which carry small risks such as discomfort, allergic reactions, or exposure to small amounts of radiation from the PET scan. All procedures will be explained in detail beforehand. Remember, you can choose to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Herz- und Diabeteszentrum, NRW
Verified postcode
Bad Oeynhausen, Germany· Recruiting

Common questions

What is aortic stenosis?

It's a condition where the main valve in your heart (the aortic valve) doesn't open fully, making your heart work harder.

What are FFR and iFR?

These are tests doctors use to check if there are blockages in the arteries supplying your heart.

What is a PET scan?

It's a type of heart scan that gives a detailed picture of how blood flows through your heart muscle.

Why is this study important?

It helps doctors understand if common tests like FFR and iFR are accurate in patients who also have severe aortic stenosis, so they can get the best treatment.

Will I have to take new medication?

The study information doesn't suggest you'll need to take new medication specifically for the research.

How to find out more

Tanja Rudolph, MD

trudolph@hdz-nrw.de +495731971258 Official trial record

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