Standardized Goal-Directed vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale
This study is looking at different ways to perform a breathing technique called the Valsalva maneuver. This test helps doctors find a small hole in the heart called a Patent Foramen Ovale (PFO). A PFO has been linked to some strokes, especially in younger people, where doctors can't find another clear cause. Currently, people are just told to 'bear down' during the test, which can be hard to do consistently. This study compares that method to a new, guided method using a monitor to see if it's more accurate at finding PFOs. If the new method is better, it could help more people get the right diagnosis and treatment to prevent future strokes.
At a glance
What is this study about?
When someone has a stroke and doctors can't find a clear reason for it, especially if they are younger, they often look for something called a Patent Foramen Ovale, or PFO. A PFO is a small, natural opening in the wall between the two upper chambers of the heart that didn't close properly after birth. It's quite common and often causes no problems, but sometimes it can allow tiny blood clots to pass through and travel to the brain, causing a stroke.
To find a PFO, doctors often do a special heart scan called an echocardiogram with a 'bubble study.' During this test, you're asked to do a breathing technique called the Valsalva maneuver. This involves taking a deep breath and then pushing down as if you're straining. This temporarily increases pressure in your chest, which can make a PFO more visible on the scan.
Right now, people are usually just given general instructions for the Valsalva maneuver, like 'bear down.' This can be hard to do correctly and consistently, meaning some PFOs might be missed. This study is testing if a new, guided way of doing the Valsalva maneuver, using a special monitor to help you breathe properly, is better at finding PFOs than the standard 'self-directed' method. If it is, this could lead to more accurate diagnoses and better prevention for people at risk of stroke.
Key takeaways
- The study compares two ways of doing a breathing test to find a heart condition called a PFO.
- A PFO can sometimes be linked to strokes where no other cause is found.
- One test method uses general instructions, the other uses a monitor for guidance.
- Researchers hope the guided method will be better at finding PFOs.
- This could lead to more accurate diagnoses and better stroke prevention for patients.
Who may be eligible?
This study is looking for adults aged 18 and over who have been asked by their doctor to have a specific type of heart scan called a 'transthoracic echocardiogram (TTE) with a bubble study.' This scan is used to check for a PFO (a small heart opening). Sex doesn't matter, and all adults who meet these basic criteria can be considered.
However, there are a few reasons why someone might not be able to join. For example, if you can't give your clear permission to be in the study, or if you can't have a small tube (IV line) put into your arm, you wouldn't be able to take part. Also, if you find it impossible to do the standard Valsalva breathing test, even with instructions, this study might not be suitable for you.
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 18 years old or older?
- Has your doctor already referred you for a 'transthoracic echocardiogram with bubble study'?
- Are you able to give your clear permission to join a study?
- Are you able to have a small needle (IV line) put into your arm?
- Are you able to perform a breathing test where you bear down or strain?
What does participation involve?
We don’t have all the details on what taking part involves, but here’s what we know. If you are eligible, you would already be scheduled for a special heart scan called a transthoracic echocardiogram with a bubble study. This study would involve doing this scan as planned, but with an additional aspect of how the Valsalva maneuver (a special breathing test) is performed. In one method, you'd be guided by a monitor, and in the other, you'd follow standard instructions. The total duration of the study or any specific follow-up appointments beyond your planned scan is not mentioned here. You would not be given any new medications relating to this study.
Potential risks and benefits
Locations (2)
- University of Ottawa Heart InstituteVerified postcodeOttawa, Canada· Not yet recruiting
- University of Ottawa Heart InstituteVerified postcodeOttawa, Canada· Recruiting
Common questions
What is a PFO?
A PFO (Patent Foramen Ovale) is a small, natural opening in the wall between the upper chambers of the heart that sometimes doesn't close completely after birth. It's common and often harmless.
Why is a PFO important?
In some cases, especially when the cause of a stroke is unknown, a PFO can be linked to tiny blood clots passing through the heart and causing a stroke.
What is the Valsalva maneuver?
It's a breathing test where you take a deep breath and then bear down, or push, as if you're straining. It temporarily increases pressure in your chest.
What is a bubble study?
A bubble study is done during an echocardiogram. It involves injecting a harmless saline solution with tiny bubbles into your bloodstream to help doctors see blood flow and structures in your heart more clearly.
Will taking part improve my health?
The primary aim of this study is research to improve future diagnosis. While your scan will inform your care, direct health benefits from participating in the study itself are not expected beyond standard treatment.
How to find out more
Dr. David Messika-Zeitoun, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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