Prove Your Heart Health With Cleerly

James Earls, MD

Thank you. It’s a pleasure to be here this evening.

Joel Kahn, MD, FACC

Maybe take a couple of minutes, and not all the audience and my podcast anywhere. Again, I talk about Cleerly Health all the time, and it’s a huge portion of my practice, but not everybody knows what it is. Why don’t you just break it down in simple terms—what it is and how it’s different? Is there anything else we’ve ever had in the heart imaging field here?

James Earls, MD

We do it clearly as we take a CT scan of the heart, and for the first time, we measure coronary atherosclerosis or the disease process itself. So we can separate the plaque from the arteries, and we can accurately determine the quantity of plaque. There are several different types of plaque. These plaques have different risks for patients. So we’re also able to determine how much of each of the different types of plaque is present. sounds like a relatively simple advance, but, for many years we measured many other things about heart disease, but we didn’t measure the disease process itself. So that’s what we have introduced to the marketplace in the last few years.

Joel Kahn, MD, FACC

It’s a CT study. It involves some radiation. We’re not talking now about calcium scoring. Many of the audience members know about calcium scoring because we’re here talking about a procedure where an I.V. is placed, and iodine contrast agents are injected. They’re not radioactive. They’re iodine. They make you feel warm. You do have to have healthy kidneys. You do have to be free of a serious allergy to iodine, and you have to chill out and get your heart rate down either spontaneously or When I had my study, I had a very low heart rate without medication, or you take a little bit of medication to make sure your heart rate is low for the quality of the study. But it’s about a 25-second, 30-second study when you get down to the brass tacks, and as you said, we can measure plaques, what kind of plaques produces amazing reports that quantify it, and get great pictures and great numbers. What do we have? I first heard of Cleerly Health C.T. angiogram studies using artificial intelligence. I first heard of them in early 2021. Maybe I was a few months late to the game. Do you know when they started to roll out?

James Earls, MD

We were founded in 2017, it took us a few years to develop a product. It was early 2020 or 2021 that we first commercialized and started to scan patients here in the U.S.

Joel Kahn, MD, FACC

I will say that no matter where you’re listening in the US—Idaho, Florida, California, Pennsylvania, Texas, Michigan, Ohio, or Indiana—you can get a Cleerly Health CT angiogram. You might get one at an imaging center that is designated as a Cleerly Health Center. But I have ordered these at university centers and large hospitals all over the United States, and for my patients, it takes just a little bit more work to get it done at UCSF, Harvard Hospital, or wherever you want it. I’m sure the company can help you arrange that if you’re interested after this conversation. I have an interesting case, but why don’t you throw a case up that you brought up? We aren’t doing these with PowerPoints typically, these are conversations, but this is such a visual thing. Why don’t you throw it up there if you have one, and then I’ll do that too?

James Earls, MD

I’m happy. You need to enable my screen share there.

Joel Kahn, MD, FACC

That may be interesting, but let’s try, you tried; there were some you said multiple participants could share. 

James Earls, MD

I do.

Joel Kahn, MD, FACC

Good. I’ve never done that before. Thank you.

James Earls, MD

Here’s a case of a patient who shows what we call a regression. On the left-hand side is the patient’s baseline study, which you can see was done back in 2017. The patient came back about a year and a half later, in 2018.

Joel Kahn, MD, FACC

I just want to tell people, to look at the purple column, and the small print says March 1, 2017, up and down with four circles. then look at the royal bold blue column, it says 10-31-2018, about a year and a half later, because most people have never seen that. These aren’t the pictures. These are the data. Maybe we’ll see the pictures that are derived from analyzing the artery pictures. But go ahead.

James Earls, MD

We’ll show a picture here in just a second. But starting with the total quantity, there were 445 cubic millimeters of plaque initially; the patient came back a year and a half later, and that was down to 311. When we divided it into the different types of plaque, you could see the non-calcified plaque. The second number in the row also went down substantially, but probably most importantly, the low-density plaque. This is the plaque, which is by far the riskiest plaque in the plaque that causes acute coronary events and went down by over 50% between the studies.

Joel Kahn, MD, FACC

I never see that much. In a few hundred studies, 67.8 cubic millimeters of waiting to have a heart attack plaque.

James Earls, MD

We take that plaque, and as you understand, the risk is that we color it red because, by far, the riskiest plaque to the patient. Initially, this image is up top. You can see this big plaque with all this red plaque within it. When they came back a year and a half later, you can see that it’s sort of like taking air out of the balloon. This plaque is much smaller; the amount of red plaque there has substantially gone down. There’s still a fair amount of red and yellow plaque there, but a tremendous change in a year and a half for this patient represents a significant lowering of their risk of having a heart attack in the future.

Joel Kahn, MD, FACC

People are looking at numbers, but you kind of got to go from left to right for 444, which was reduced to 311, which means the amount of, I’ll use a term, not everybody likes crap in the arteries was reduced. This is reversing heart disease, everybody. But we’re proving it in a way that’s measurable and academic. then there are different kinds of plaque. This patient was nothing but a fat blob because almost all the plaque is called non-calcified plaque. This patient would have had essentially a calcium score if you went for the low-cost routine CT scan of zero, one, or two, yet he was carrying a huge burden of dangerous stuff. This is why your company doesn’t stress the calcium score because you’re going to miss it. Here’s an example. You’d miss an enormous amount of risky disease in the heart arteries if you just went with a low-cost calcium score. 

James Earls, MD

That’s right. For many years, of course, we predominantly used the calcium score because that was the only type of plaque we were able to follow. But with advances in imaging as well as A.I., we can now look at the other types of plaque, and it’s the other types of plaque that place you at risk. So, yes, certainly there are cases where patients have low calcium scores, and that can give you a sort of false sense of security in some situations because, with a low calcium score, you could still have a relatively high amount of the other types of plaque, which are riskier. Certainly, there are times, of course, when a low calcium score also means there’s a low non-calcified plaque burden, but in some cases, it can go the other way around.

Joel Kahn, MD, FACC

I would predict that, of course, we’re not presenting the whole patient here and their labs, but the few I’ve seen are this dramatic, like almost no calcified hard plaque. I call the non-calcified plaque the fatty, buttery, cheesy plaque in the office because I want them to understand that’s not what they’re supposed to be eating. I would predict this patient is overweight has metabolic syndrome, or is pre-diabetic, and inflammation, and LDL particle numbers are crazy because to get this kind of fat-filled heart arteries, you have to be metabolically just a disaster. It’s unusual.

James Earls, MD

You’re right there. If you look at the background here, you notice this is a very noisy scan, which is something that generally happens in obese patients. I do believe this patient is substantially overweight. that was one, has metabolic syndrome or other metabolic abnormalities that contribute to this high amount of blood plaque.

Joel Kahn, MD, FACC

I don’t think we’ve seen a picture yet of the arteries. Maybe you’ve seen it. Well, what we’re seeing is data, which is great. But can you?

James Earls, MD

I’m sorry, it was.

Joel Kahn, MD, FACC

Now we’re looking at the actual arteries color-coded, like you mentioned red for risk yellow for soft, and blue for the calcified plaque. You can’t even see any calcified plaque because the number was so low, and this is the baseline above and the follow-up below. Look how much of the red went away. And do you know what they did? I imagine massive pharmacologic drug therapy.

James Earls, MD

This patient was on a PCSK9 inhibitor for about 18 months.

Joel Kahn, MD, FACC

That’s for people who are aware of drugs like Repatha and Praluent; you have to inject them every two weeks. You have to get insurance pre-authorization. I’ll say that because we have a lot of listeners who are plant-based eaters, we don’t know because it hasn’t ever been studied. If you can get these same results by just eliminating animal foods and eating whole plant foods, as Dr. Ornish talked about, you could, but I don’t think you could do it this quickly. Remembering Dr. Ornish, his study was a five-year follow-up. Here we got about a year and a half. In my clinic, we teach excellent nutrition, but we use supplements and pharmacologic agents to attack this from multiple routes. Excellent.  

James Earls, MD

They got to see their drill. that plant-based diets can also cause favorable plaque changes. I’d love to see a good randomized controlled trial proving that, but at least anecdotally, we have seen patients that we support who have come back within a couple of years and had very favorable plaque changes in those situations.

Joel Kahn, MD, FACC

Good. We need to get the Broccoli Sprout Growers Association to fund that thing, but they’re going to have to come up with 10 or $20 million. What do you want to show another one? Then I’ll perhaps.

James Earls, MD

Share another case here. I will see some similar favorable numbers in this case. There is a larger overall reduction. This patient had a 60% reduction in their total plaque volume over about a year and a half or a year and a couple of months. In this case, this patient also had Inclisiran, which is a new injectable medication. You can see that a much lower amount of low-density plaque started at six cubic millimeters but drove it down to zero. What we typically see in these cases, where the non-calcified plaques are decreasing, is a little bit of an increase in calcified plaques, as that non-calcified plaque often gets transformed into calcified plaques. An increase in calcified plaque or an increase in the calcium score can sometimes be a good thing because it represents the conversion of the non-calcified plaque into the more stable and benign calcified plaque.

Joel Kahn, MD, FACC

I want people to look at us perfectly, and before you go, I just want to go back to our purple column and look up and down, that’s January 2022. It’s a new term for most people. If the TPV total plaque volume is 349 millimeters, then look to the right, 13 months later, 349 is down to 138. You helped me out here. 60% of the plaque in the heart arteries disappeared in 13 months. That is amazing in this case because of a powerful drug agent that lowers cholesterol. This is a patient like the first one. Most of the plaque was fatty, buttery, and cheesy. There’s my bias again: plaque, non-calcified plaque. The calcium score wouldn’t have been very impressive here, but the disease is impressive, and 68% of their fatty plaque. It’s just like sucking it out with a suction machine. But we did it with, in this case, maybe some lifestyle—I don’t know the patient—but powerful medication. I tell you, the number one question I get asked is: How do I lower my calcium score? It’s what you just said. I tell them, I don’t think you can, and I’m not sure you want to, and I’m not sure if your calcium score wanders up a little bit. It’s so bad we got to get rid of this soft plaque, which we did here quite well; it just shows the picture by clicking a number eight or nine. I this the same patient?

James Earls, MD

Yes, this is the same patient. On the top, you can see that the blue plaque here is the calcified plaque, as we had said earlier. But you can see it’s sort of surrounded by the yellow plaque. We have a yellow plaque there below it. Then, when they came back a year and a half later, you could see the calcified or blue plaque remains. A lot of that yellow plaque has now disappeared. again, very favorable for him. There was a slight increase in the overall amount of calcium, but a dramatic decrease in the amount of non-calcified plaque, which, as a result for this patient, resulted in a dramatic decrease in this patient’s risk of a future event.

Joel Kahn, MD, FACC

Isn’t that great? People can get a Cleerly scan; they have to get a physician to order it, and I can tell you firsthand that the majority of cardiologists so far have not ordered Cleerly scans. That will change. It is still largely a cash-only luxury item. If you call your health luxury item a luxury, I got essential, but I’m seeing more and more of my patients. I had one today. Tell me, hey, doctor, half of my Cleerly scan was covered by my insurance. It’s changing somewhat, which is good. It defines it better than anything else on the planet. I tell patients that Cleerly, you just got the same test that the wealthiest person in the world could get to evaluate the heart. There is nothing better, and I don’t mind shouting it out. It’s about 1500 dollars plus or minus a little bit. It’s not 15,000 or something completely out of range, and people may have to dig into their pockets a bit to come up with it, but then you might want to do another one and, after 15 months, 20 months, or 36 months, depending on your risk, see how much it’s improved. Of course, they developed out of research studies with Dr. Min and others around the country. Are there any research studies right now in which an academic center is using this technology to study a drug, a gene therapy, or anything else on the planet?

James Earls, MD

There’s a tremendous amount of research currently going on. We have about 30-odd trials that we’re participating in, mostly in the United States but also overseas. looking at the effect of different medications on sex, age, and race, among other biomarkers of disease. We’re using our tool to quantify it and to see what changes may take place. A lot of research is going on. We’re standing up. A very large trial of asymptomatic patients will currently enroll about 8,000 patients over five years. We have that the first patient should be enrolled in the next month or so, but there will be quite a few places across the U.S. enrolling for that trial.

Joel Kahn, MD, FACC

Better call me; I’ll put a few in. If anybody’s listening and they’re very wealthy and they want to fund a plant-based, randomized study, or just people with a completely plant-based baseline study, a follow-up call Dr. Earls. Let’s fund that thing. Maybe our friend John Mackey, who sold Whole Foods to Amazon by chance, wants to do that and improve that concept. We’ve been talking for a little bit, and it certainly is fascinating. We’re going to take a brief break, say goodbye to our general audience, and stay for a little bit longer with our premiere package group. I just want to ask you a person who’s excited about this, and they should be everybody. Your website is a good place to start to learn a little bit more.

James Earls, MD

You certainly have information about the technology on our website; some of our research information is there. There’s also information on what centers around the country. You can put your zip code in. It’ll tell you what centers are closest to you. We’re still relatively new companies, and we do have cities and towns in the U.S. that we don’t have centers in. But as you suggested, many people still have a place. You can get a CT locally, and then you can get in touch with us for the processing of the exam.

Joel Kahn, MD, FACC

I periodically get emails. Your company does fairly interesting webinars where you put in your email and you get alerted that it’s there, and if you missed it, you can watch the recording. It’s okay, and they’re free. Is it okay for members of the public to want to participate in that?

James Earls, MD

Yes. We do design them for healthcare providers, but we have lots of patients who join. I’m always surprised, frankly, at the sophistication of the questions that we get from our non-physician and non-provider participants.

Joel Kahn, MD, FACC

Excellent. I want to thank you for this overview. Everybody, hang tight. Don’t go anywhere. We’ll be right back. For a good reason, we’re back with Dr. Earls, currently with cleerlyHealth.com. It’s the most exciting cardiac imaging company out there. We’ve just seen some amazing examples. They happen to be examples of extreme amounts of what is called non-calcified soft plaque, which, fortunately, with intensive therapy, was a very dangerous black that shrank significantly in a relatively short time. Other people are different, and there’s a largely calcified plaque that makes it a little harder to move the needle. I brought a case and let me see. I may have to go. Let me see. Shared screen. I cut you off from sharing for a minute, but I can go back, all. I wasn’t sure I was going to have the technology. You can see that, Dr. Earls.

James Earls, MD

Yes, I can see it.

Joel Kahn, MD, FACC

You probably crafted this comparison. It was sent to me by a patient I had yesterday. It’s very current. I don’t yet know how to put these together in this beautiful way. For everybody watching, there’s a purple column that says compared. If you look, it has a date of 12/8/22,  and then to the right is a royal blue column up and down. That’s just about eight months later, on July 26, 2023. This language is all new, but there’s a total plaque volume. That’s the language of how much plaque is in the three heart arteries. That can be a problem, leading to a heart attack with stents. It was 546. But this is not a happy case. I want to make a point from it because if you look eight months later, it’s gone up by 40% from 546 to 758. That soft, buttery, cheesy, non-calcified plaque for a 17.37% increase went up. That’s not what we want to do. I was not involved in the patient’s care during these eight months. Divide 72. Now, Dr. Earl Gray told us there’s a particular kind of dangerous black called low-density, non-calcified plaque that did go down from 13 to 2, which helped this patient out. Finally, the calcified plaque went from 128 up by about 45%, a little bit more than you typically see in eight months. The final thing I’d like to comment on is that there was one severe narrowing in the baseline study and two severe narrowings because you do get that information. We haven’t talked about that, but there were two narrowings. There were 71% narrowed on the follow-up study, whereas in the first one, it was one. The question is, what did this man, who is 60 years old, do in eight months to create this? This is such a fascinating case because he did see an integrative cardiologist. He was put on a few supplements. I will tell you, that one of the supplements he was put on was Aged Kyolic garlic, which has some data for shrinking soft black. That’s why his low-density, non-calcified plaque went down, because that’s about the only agent he was on that might do that. But he chose I was not involved in his care to not dramatically change his diet or his lifestyle. It wasn’t that bad, but it shows the change, and he did not go whole-food plant-based.

He did not want to go on a statin or other prescription medicine. He did 25 treatments of chelation with EDTA, and he did 45 treatments with another agent some practitioners use called Plaque Acts. These are intravenous infusions. He ended up spending for eight months about $10,000 in cash at an integrative clinic in the Chicago area. I’ll say that. expected when he did his follow-up with Cleerly Health to see dramatic improvement when, indeed, there is no data at this point for any kind of CT Angiography analyzing chelation therapy. Something that’s been around for decades and has little glimmer of hope that it may help patients, but not direct imaging studies to prove that it restores heart anatomy, This was a disaster for this guy in terms of what resulted. He was spending a lot of money and a lot of time because you sat in a chair for two or three hours to get these infusions, and it didn’t work for him. I pointed that out. I’m going to write this study up because I don’t know how many other comparisons are like this. Does key lesion therapy work for many people in the audience of articulation therapy? It’s usually intravenous. You can try to do it orally. It used to be done with suppositories, too. There’s that route, so that, girls. Have you seen other chelation examples?

James Earls, MD

But only a handful? It’s not as widely done as perhaps it may have been done in the past, but here it was not effective. What we’re seeing is that coronary atherosclerosis is a progressive disease, and left untreated or inappropriately treated, it continues to progress. Many therapies work for some people, but they don’t all work for everybody. One of the best parts of our ability now to quantify disease is that we can show whether it’s working or not. Then you have the opportunity, as this man now does, to change therapies or do something else that may, in his particular case, work more effectively. Of course, we do see a benefit here in low-density plaque, but the overall amount of plaque and the amount of non-calcified plaque progressing here for him represent the very opposite of what he was hoping to see here.

Joel Kahn, MD, FACC

No doubt.  For the audience listening, the main focus of this presentation is Dr. Earls, a very prominent cardiologist in Miami. I want to say his name right? Gervasio Lamas, M.D., did pull off a $30 million study published in 2012 using chelation in 1700 men in the VA hospital system. They did not have enough funding to do calcium scoring before and after, so there was no imaging data, and there was no Cleerly Health Imaging data because it didn’t exist when the study was done. However, there was some evidence that the patients did better over the study, enough that they’re repeating the study because only diabetic patients demonstrated some clinical benefit, and we don’t have the results of the second phase. It’s called the TACT2 trial, but they also aren’t doing hard imaging. They’re not doing calcium scoring. Even when those studies are done, we’re not going to know what’s happening in the coronary arteries. But when you look at this single case, you have to say, how does Chelation even possibly work? Because there is some data for severe peripheral vascular disease, leg disease, and leg circulation, there is some provocative data. It’s called TACT3a there may be some role, but I was almost getting revved up to start recommending chelation again to my patients once in a while. After this example yesterday, I don’t think I’m going to ask anybody to spend money on this. Do we have more data?

James Earls, MD

Perhaps they are looking at some other marker of the disease that may have looked favorable. But, the plaque itself, which is the disease, did not respond favorably. That’s why, for many years in cardiology, you often followed certain biomarkers of the disease that we would assume go hand in hand with the actual plaque or atherosclerosis. Certainly, sometimes they do. But there are times when all of your lipids could turn favorably, but your plaque can still be progressing, even in the light of a very favorable lipid profile.

Joel Kahn, MD, FACC

In just a couple more minutes. We have an audience here that wants to stay healthy. They’re very lifestyle-oriented. Should everybody over the age of 40 or 45 get some kind of cardiac blood vessel imaging? The two choices are a calcium score, which is without a dying die and low cost, but you don’t see soft plaque. We’ve seen these examples today. How much can you miss, or should the majority get the corner CT angiogram if they have a center and the finances to have one? Or how are you handling that recommendation?

James Earls, MD

We hate to have a type of therapy that only people who can afford it can follow. We are working hard to one day get indications, and hopefully, CT angiography can be used as a screening test and will be covered by insurance. But we have to generate a lot of good data before that happens here in the U.S. If you are interested and you can afford it, it’s a very compelling test that will tell you precisely where you are and what work you may need to do, or you may find that you have a favorable study and what you’ve done already has been good for you. But yes, if people can afford it, it’ll give them a lot of information, which can be very motivating for people to see their plaque. Many of our providers tell us they’ve had patients who, for years, have tried to lose weight, stop smoking, or get on a better diet. But once they finally saw their atherosclerosis, that was a great motivator to allow them to make that lifestyle change or, in fact, perhaps start taking pharmacological supplements that they were originally resistant to. If people can afford it, it’s great. But we do hope to generate evidence that everybody will be able to afford it by using their health insurance at some point in the future.

Joel Kahn, MD, FACC

I’ll say I had a patient today in the clinic. A very boisterous, 70-year-old attorney just walked in and said, We have an hour together, but it can be one minute. I just want a healthy angiogram, and I need a doctor like you to write the script and set it up. We ended up spending an hour together talking about his health, golf, and a whole bunch of other topics. But that was a good choice. He has every risk factor in the book, and he knew going right past the calcium score to a more informative test, and he has good kidney function and no iodine allergy problem. No problem there. It is kind of the cutting-edge thing that we’re all learning about. Thank you for sharing your time, your knowledge, and your case studies. The audience has enjoyed this and learned a lot. It’s just that we all talk about reversing heart disease, but you’re the team that knows how to improve it.

James Earls, MD

Well, and you’re the team that knows how to do it. So together that’s great.

Joel Kahn, MD, FACC

All right. Thank you, sir.

James Earls, MD

All right. Thank you, Dr. Kahn.