Melanie Cole (Host): Welcome to Better Edge, a Northwestern
Medicine Podcast for physicians.
I'm Melanie Colon.
Today we're discussing the phase three enhanced trial of novel contrast
agent for cardiac bubble studies.
Joining me is Dr.
Akiel Nang.
He's an associate professor of cardiology at Northwestern Medicine
Bloom Cardiovascular Institute, And the director of the Echocardiography
Laboratory at Northwestern University.
Dr.
Nang, thank you so much for joining us today as we get into
this really interesting study.
Tell us a little bit about bubble studies themselves And
the current indications for use.
Where are we seeing these done?
Dr Akhil Narang: Sure.
Absolutely.
Thank you for having me.
So bubble studies are.
A fundamental component of an echocardiography exam in certain
situations, and they are performed usually when there's a suspected
right to left shunt, for instance, A PFO or an atrial septal defect.
But we also use it for evaluation of unexplained hypoxemia, And also stroke
or systemic embolism of unclear etiology.
So there are multiple indications in which a provider might order an
agitated bubble study or solution study.
Melanie Cole (Host): Well, thank you for that.
So before we dive into, enhance, briefly walk us through the current standard of
care for these cardiac bubble studies using agents like agitated saline.
As you were just mentioning.
What works well?
What are some of the pain points?
Why are we doing the study?
Dr Akhil Narang: Absolutely.
So in the current practice, agitated saline or bubble studies are performed
by taking a eight CCC syringe or nine CCC syringe filled with saline.
One CC is air And the two syringes are agitated together to be able
to produce micro bubbles, which are then injected in the vein.
And, ultrasound is then used to, detect a ification of the right side
of the the heart, And then to determine if There are any bubbles that pass
into the left side of the heart.
So the current process right now utilizes usually two people, a three-way
stopcock and a manual agitation process.
And as you can imagine, there's a lot of variability in that process.
So how quickly the bubbles are agitated, it requires multiple people.
it creates non-uniform bubble sizes.
And so the current process right now relies on.
Separate techniques such as coughing in order to enhance the
opacification of the right side of the heart and improve detection
of the bubbles into the left side.
The problem with, what I mentioned is the non-uniformity that we have
in the current practice, And so the.
Enhanced study aims to investigate a new device that will standardize
saline contrast for echocardiography.
So This is a prospective trial that uses a attachment to the Salient
syringe, and it uses a compound called Polysorbate 80, which acts like a small
surfactant that coats the bubbles and allows for more clear ification of
the right side of the heart, And also uniformity in terms of the bubbles.
And it also can be done with a single user as opposed to needing
to have two users at the bedside.
Melanie Cole (Host): That's fascinating.
That's just so interesting.
So, expand a little bit, give us an overview of Enhance itself
And the objectives and your role as the primary investigator.
Dr Akhil Narang: So as I mentioned, it's a prospective clinical study evaluating
a novel standardized saline contrast tool for echocardiography, And the
objective is to improve consistency, reliability, and diagnostic accuracy of
saline contrast imaging, particularly for shunt detection and right-sided.
to left-sided shunts.
So, as the principal investigator for this multicenter trial that expands
over five sites in the United States and Canada, my role is to oversee
the design, implementation, and clinical integration of the trial
while ensuring that the results are meaningful, not just academically,
but for real-world echo practice.
So I oversee the extent of the trial across all of the five different sites, in
addition to oversight of the trial itself.
Melanie Cole (Host): So how does it aim to improve that diagnostic efficiency?
You mentioned, you know, the many people involved and reproducibility,
and how can clinicians expect the use of this new contrast agent to
streamline those workflows that you were just discussing in the Echo Lab?
Dr Akhil Narang: Absolutely.
So saline contrast is widely used right now, but it's highly variable
depending on how it's agitated, injected, timed, And so this variability can
lead to suboptimal opacification.
Inconsistent bubble size and often non-diagnostic studies,
which lead to repeat imaging.
So the enhanced study attempts to address this with this ready to use
standardized contrast tool that produces more uniform microbubbles, resulting in
a clearer, more reproducible imaging.
So the goal is to reduce operator dependence on more than one
person being at the bedside.
Improve diagnostic confidence across patient's.
Also sonographers and repeat the need for, repeat injections or testing.
So this potentially could lead to shortened exam time.
Minimize equivocal results for clinicians and sonographers.
This means less troubleshooting, fewer repeat studies, and potentially
faster diagnostic decisions, which can translate to improved lab efficiency
and better patient throughput and care.
Melanie Cole (Host): Dr.
Nang, who's eligible to enroll, what patient's can benefit from enhance, and
as the first patient enrolled moments come with a lot of operational choreography.
Tell us a little bit about what went into getting the Echo Lab cardiology
team and all of the people involved.
Dr Akhil Narang: So patient's undergoing a clinical echo exam where saline
contrast study is clinically indicated, such as for evaluation of intracardiac
shunts, or detection of asds or PFOS in the setting of unexplained strokes.
These are patient's that are involved, or could be recruited for the study.
This could be an inpatients or outpatients.
We're limiting this to adult only patient's.
who are also of, non-pregnant status as well.
And so these are the patient's that are already coming into the Echo
Lab for a saline contrast study.
And, from that patient population, we can recruit them into the clinical trial.
Melanie Cole (Host): So cardiac bubble studies are generally low
risk, as you and I discussed a little bit, but any new injectable
still has to clear that safety bar.
What do we know so far about the safety profile from early phase data?
Dr Akhil Narang: the product is actually used in Canada at present, and there
have been no known contraindications for the use of the device, And so it's
a very safe, device to be able to use.
As I mentioned, there's polysorbate 80, which is basically a, non ionic
surfactant that's commonly used in pharmaceutical preparations.
That's part of the.
Tool that we're using for the agitated, salient study.
it's a larger group of polysorbate, which are well characterized, and have a common.
Structure similar to other things that are already used medically.
And so the safety profile has been very safe at this point in time.
The US FDA has really, high thresholds after which polysorbate become
potentially unsafe, And so the agent is well under those maximum daily
exposure thresholds for the agent.
Melanie Cole (Host): And what are the implications for care at
Bloom Cardiovascular Institute?
How does this demonstrate how the team is leading the way in
cardiovascular advancements?
It's very exciting.
Dr Akhil Narang: Definitely.
So this trial reflects Bloom's commitment to innovation that directly improves.
Everyday clinical care.
And so rather than only focusing on normal therapeutics, enhance
addresses a fundamental diagnostic tool used in daily echocardiography.
And This is part of many clinical trials at Bloom Cardiovascular Institute
that span all disciplines within the cardiovascular space, including many
in the echocardiography laboratory.
And I think furthermore, it demonstrates our, our team continuously evaluates
advances in imaging and echocardiography.
To improve quality, efficiency, And also patient experiences while helping
shape best practices that could be adapted nationally and beyond.
Melanie Cole (Host): Dr.
Noran as we wrap up.
Anything else you'd like other physicians to know about this trial?
And for clinicians listening today, what's the one thing you want them to understand
about why this specific trial matters?
Dr Akhil Narang: I would say this enhanced trial is really rooted in
real-world clinical practice and addresses a problem that we encounter
all the time in echocardiography with the current state of practice with.
Bubble studies.
So if Han is successful, it could meaningfully change how saline contrast
is performed across Echo Labs around the world, really improving standardization
and diagnostic reliability.
And I think this exemplifies how thoughtful or pragmatic research led
by Bloom Cardiovascular Institute in many of the teams here can
have really an outsized impact on patient care and clinical workflows.
Melanie Cole (Host): Thank you so much, Dr.
Nang, for joining us today and sharing your expertise on this trial.
And to refer a patient or for more information, please visit
our website at Breakthroughs for physicians.nm.org/cardiovascular
to get connected with one of our providers.
That concludes this episode of Better Edge, a Northwestern
Medicine Podcast for physicians.
I'm Melanie Cole.