Lipid disorders represent the most important risk factor for the development of what we call atherosclerotic coronary vascular disease and its complications, including heart attack, stroke, and peripheral artery disease leading in some cases to amputation. Other risk factors, including inflammation, hypertension, tobacco use, obesity, and family history, also play significant roles.
Atherosclerotic coronary vascular disease or ASCVD is a disease process akin to “rusting of the arteries,” where plaque is formed in the walls of the arteries, and when it blocks the artery by 70% or more leads to symptoms such as angina or chest discomfort with exertion or claudication which is calf pain with activity. The plaque formation in the arteries also predisposes to sudden blood clot formation or what is termed thrombosis, which can suddenly lead to 100% blockage of an artery leading to heart attack or myocardial infarction, stroke, or placing an extremity at risk for amputation. ASCVD is a process that takes years to develop and can remain silent with no symptoms until blockages become severe. The problem is that thrombosis or complete artery occlusion can occur in arteries with only mild to moderate blockages, so patients may not have warning signs of heart attack or stroke. We can identify the presence of plaque early on using easy-to-access testing such as a coronary calcium score, coronary CT angiogram, or carotid ultrasound.
The components of lipids that contribute to cholesterol are well known and include LDL (bad cholesterol), triglycerides (cholesterol precursor), and lipoprotein (a) (the horrible cholesterol. The elevated levels of these lipids bathe the arteries as they circulate in the bloodstream and invade the wall of arteries causing rusting or ASCVD to occur.
Aggressive treatment of LDL and triglycerides has been shown to prevent plaque development and complications, including heart attack and stroke. The mainstays of treating LDL include statins, ezetimibe, and PCSK9 inhibitors, with the Omega fish oil eicosatetraenoic acid for treating triglycerides. If we achieve very aggressive lipid reduction, such as an LDL level < 50 mg/dl, we are more likely to see some plaque regress. Clinical studies have shown the limitations of these cholesterol-lowering medications to lower lipids to recommended levels as they may not be potent enough, may not be affordable, or patients may not tolerate side effects, particularly muscle achiness with statins. Lipoprotein a, the horrible cholesterol, is a particularly toxic lipid that contributes to the development of heart attack, stroke, peripheral artery disease, and aortic stenosis. Elevated lipoprotein (a) is a genetic disorder that is inherited in a dominant fashion, meaning that siblings and offspring of afflicted people have a 50/50 chance of suffering from elevations. Unfortunately, there are no commercially available treatments; they are only available at this time in clinical trials.
At the National Heart Institute, we are committed to finding more effective, safer, and better-tolerated treatments across the spectrum of cardiac risk, from reducing LDL, triglycerides, lipoprotein a, and inflammation to newer treatments for heart failure, obesity, hypertension, diabetes, and chronic kidney disease and cardiac and vascular disease. All clinical trials are approved by the United States Food and Drug Administration, providing eligible patients who meet specific criteria the opportunity to participate in these clinical trials. There is no cost for participation, and patients who are enrolled in clinical trials receive a financial stipend for their participation. Generally, patients continue with their current treatments that their physicians or other healthcare professionals prescribe, so we generally do not replace current well-tolerated treatments but rather complement them with clinical trial treatments.
In clinical trials, patients are randomized to either the medication being studied or a placebo, as we need to be sure that any treatment is more effective than a placebo. Even the patients receiving the placebo benefit from the special diagnostic testing depending on the specific needs of each clinical trial, such as special blood tests, cardiac and vascular ultrasounds, and special CT and MRI scans/ in a clinical trial and having an extra pair of eyes following their health condition in addition to their health care team. Generally, the evaluated treatments are not commercially available and cannot be accessed in pharmacies in the United States or abroad. Participating in a clinical trial provides patients the potential to be exposed to these treatments being evaluated earlier than people waiting for commercial availability. They also provide a tremendous public service by helping us in a voyage of discovery to improve the health of each participating patient and the health of others.
Our lipid trials all have different entry criteria that must be met before enrollment. In some, we are seeking patients who have had a history of a heart attack, stroke, or peripheral artery disease, who have undergone arterial stent procedures or bypass surgeries, or have been told they have arterial plaque as seen on a CT scan or ultrasound or who have lipid abnormalities (LDL > 55 mg/dl, or triglycerides > 150 mg/dl or lipoprotein (a) levels > 90 mg/dl or 150 nmol/l) or evidence of inflammation with a test called hsCRP > 2 mg/L.
If you have been diagnosed with lipid or cholesterol disorder, feel free to reach out to the National Heart Institute, a center of excellence for clinical trials, to answer any questions and provide information on our currently enrolling clinical trials.
We will work with you and your healthcare team to select the best trial for you. There is no cost for participating in a clinical trial; if selected, most trials provide payments for each study site visit.
To learn more, visit our website at www.nationalheartinstitute.org
or contact us at: info@nationalheartinstutute.org.
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