Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
This research study is looking at a new test called ASI-02, which helps doctors look for a heart condition called a `'right-to-left shunt'`. We're comparing ASI-02 with the current standard test, known as `'agitated saline'`. The main goal is to check if ASI-02 is safe and if it's as good as the current test at finding this condition using a special type of heart scan called an `'echocardiogram'`. Participants will try both tests on the same day, with a few injections for each, and the total time involved in the study is very short, usually 24 to 48 hours. This study hopes to find an effective and safe new option for detecting this heart issue.
At a glance
What is this study about?
This study is about a heart condition called a 'right-to-left shunt'. Imagine your heart has several chambers, and sometimes, there can be a small opening that allows blood to flow from the right side to the left side, which isn't its usual path. This is what we call a 'right-to-left shunt'. Doctors often find this using a special test called an echocardiogram, where they inject a bubbly saline (saltwater) solution to see how it moves through the heart. The current standard test uses what's called 'agitated saline'.
We are testing a new solution called ASI-02. The main goal is to see if ASI-02 is a safe and effective alternative to the current agitated saline test. Think of it like comparing two different types of gentle 'dye' or contrast agents used during an ultrasound scan of your heart. We want to find out if the new test is just as good, or perhaps even better, at highlighting these shunts in your heart.
By taking part, you would help doctors understand if ASI-02 can be a new, reliable option for diagnosing right-to-left shunts. This is important because having more safe and accurate diagnostic tools allows doctors to make better decisions about patient care and treatment.
Key takeaways
- Compares a new test (ASI-02) with the standard 'agitated saline' test.
- Aims to find out if ASI-02 is safe and effective for detecting heart shunts.
- Involves heart ultrasound scans (echocardiograms) and injections.
- Participation is short, typically 24-48 hours.
- Helps improve diagnostic options for a heart condition.
Who may be eligible?
To join this study, you need to be at least 18 years old and your doctor must already be considering a saline contrast echocardiogram scan for you because they suspect you might have a right-to-left shunt. You also need to be able to understand and communicate with the study doctors and nurses.
However, there are certain reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you could become pregnant and are not using effective contraception, you cannot take part. Also, if you have a known allergy to a substance called polysorbate 80, this study won't be suitable for you. We also can't include people with very unstable or severe pre-existing heart conditions, very high or very low blood pressure that is not controlled, or other serious illnesses that the study doctor thinks would make it unsafe 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.
- Are you 18 years old or older?
- Has your doctor suggested you need an echocardiogram to check for a right-to-left shunt?
- Are you able to speak freely with the study staff?
- Are you *not* pregnant or breastfeeding, and if you could get pregnant, are you using reliable contraception?
- Do you *not* have an allergic reaction to polysorbate 80?
- Do you *not* have severe, uncontrolled heart or blood pressure problems?
What does participation involve?
If you decide to take part, you'll visit one of the study centers, which are located in the UK. On a single day, you will receive injections of both the new test solution (ASI-02) and the standard 'agitated saline' solution. This will happen during a special heart ultrasound scan called a transthoracic echocardiogram (TTE). You'll receive two injections of ASI-02 and four injections of the agitated saline solution.
The order in which you get these injections will be decided randomly, like flipping a coin. You will be monitored closely during and after these tests. The total time you'll be involved in the study, from your first visit to your last, is very short – generally between 24 and 48 hours.
Potential risks and benefits
Locations (6)
- Northwestern UniversityVerified postcodeChicago, United States· Recruiting
- Mayo ClinicVerified postcodeRochester, United States· Recruiting
- CentraCareVerified postcodeSaint Cloud, United States· Recruiting
- Jackson Heart ClinicVerified postcodeJackson, United States· Recruiting
- NYU Langone HealthVerified postcodeNew York, United States· Recruiting
- Toronto GeneralVerified postcodeToronto, Canada· Recruiting
Common questions
What is a 'right-to-left shunt'?
It's a condition where there's an unusual pathway that allows blood to flow from the right side of your heart to the left side.
What is an 'echocardiogram'?
It's a type of heart scan that uses sound waves to create moving pictures of your heart and blood flow.
Will I know if I'm getting the new test or the standard test?
Yes, you will receive both the new solution (ASI-02) and the standard agitated saline as part of the study, so you will experience both.
How to find out more
Pamela Wolfe
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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