Cardiovascular Disease, or CVD, remains the number one cause of death in the US and the rest of the Western World. CVD is typically defined as a history of heart attack, ischemic stroke, coronary stent, hospitalization for unstable angina, bypass surgery, extensive coronary artery disease, or peripheral artery disease. We have many strategies to decrease the prevalence of CVD including: weight loss, smoking cessation, increased exercise, LDL cholesterol reduction, management of high blood pressure (hypertension), and the use of select diabetes medications. Researchers are continuously searching for more and better ways to reduce the risk of CVD. Clinical studies are ongoing and will hopefully find novel methods to diminish the impact of CVD on our nation.
Familial Chylomicronemia Syndrome
Familial Chylomicronemia Syndome, or FCS, is an ultra-rare genetic disorder that leads to lifelong extraordinarily high triglyceride (TG) levels. Five genes are responsible for the disease, although it is believed that some genetic mutations are yet to be identified. Also, there are even rarer cases of autoimmunity causing the disorder. It is believed that 1,000 – 1,500 people in the US are afflicted with FCS. Dr. Seth Baum, Founder and CEO of Excel Medical Clinical Trials (EMCT), is an international expert in managing this disease. He treats patients with FCS and has conducted clinical trials in this patient population.
Familial Hypercholesterolemia, or FH, is separated into 2 forms, heterozygous (HeFH) and homozygous (HoFH). The former is common, afflicting 1/220 Americans while the latter is rare, impacting 1/300,000 Americans. FH is a genetic disorder in which one of 3 genes experiences mutations that cause a significant in LDL cholesterol (formerly dubbed the ‘bad’ cholesterol). In HeFH, LDL levels are typically in the 190 to 350 mg/dL range while in HoFH levels are often greater that 400 mg/dL. Dr. Baum, the Founder and CEO of Excel Medical Clinical Trials (EMCT), has been active in publishing, teaching, and advocating about FH. He is also a board member of the FH Foundation https://thefhfoundation.org. FH leads to frequent premature heart attack, stroke, and even death. Early identification of FH is critical, as early treatment leads to far better outcomes. It is important to recognize that certain populations, such as French Canadians, Ashkenazi Jews, Christian Lebanese, and South Africans are at much greater risk for FH. It is also critical to understand that as a genetic disorder, FH is a family disease. Finding family members with FH can save their lives. EMCT continues to conduct numerous studies in patients with FH in order to find better strategies to treat, and hopefully one day cure, this common ailment.
Congestive Heart Failure, or CHF, is a common disorder in which the heart muscle cannot adequately move blood around the body. Consequently, blood backs up in the lungs causing shortness of breath, and the feet causing swelling. Patients with CHF are often fatigued, short of breath and unable to perform tasks of normal daily living. There are two main types of CHF: A boggy and dilated heart that cannot pump (HFrEF) and an extremely stiff heart that cannot adequately receive enough blood (HFpEF). Medications have been FDA approved for HFrEF, but life expectancy is still markedly reduced. No FDA drug has been identified for HFpEF. Excel Medical Clinical Trials (EMCT) is conducting studies in both conditions.
Hyperlipidemia/Hypercholesterolemia represent the greatest population attributable risk for cardiovascular disease (CVD). As CVD remains the number one cause of death in the US – from stroke, heart attack peripheral artery disease and congestive heart failure – Excel Medical Clinical Trials (EMCT) conducts numerous studies in this area. It is important to recognize that LDL cholesterol has been proved to cause CVD. The lower the LDL, the lower the risk of CVD. Many doctors, including Dr. Seth Baum, the Founder and CEO of EMCT and a cardiologist/clinical lipidologist, teach that “the lower the LDL the better.” In fact, no bottom has been identified for an LDL in which harm is done. Levels under 25 mg/dL have even been studied.
Hyperlipoproteinemia(a), or elevated Lp(a), is a relatively common condition afflicting 20% of the U.S. population. This type of “atherogenic LDL” must be specifically tested when one goes to the doctor. In other words, doctors often do not test for this marker unless specifically requested by patients. Though Lp(a) is correlated with heart attack, stroke and aortic stenosis (narrowing of the aortic valve), many doctors do not test for it because there is no direct cure. Other clinicians will more aggressively lower patients’ LDL levels when they find an elevated Lp(a). Now, Excel Medical Clinical Trials (EMCT) and others are conducting studies with medications that potentially lowers Lp(a).
Hypertriglyceridemia (HTG) is a common condition in which TG, the major fat source we consume, is elevated in the blood. Our ‘normal’ TG level is < 150 mg/dL, but many clinical lipid specialists, like Dr. Seth Baum – Founder and CEO of Excel Medical Clinical Trials (EMCT) – believe optimal levels are < 70 mg/dL. High TG are believed to cause heart attacks and strokes, so researchers are studying the effects of TG-lowering medications. EMCT is conducting a number of such trials. HTG are often associated with diabetes mellitus, overweight, obesity and hypertension.
Liver Diseases – NAFLD, NASH, and PBC
Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH) are common liver diseases that afflict approximately 25% of our population. Diabetes Mellitus (DM), hypertension (HTN), high TG, high LDL cholesterol, overweight and obesity are typical culprits. Currently, no drugs have been FDA approved to treat these conditions. These conditions of excess fat in the liver are not only common, but they also can lead to cirrhosis, liver cancer and liver transplantation. Thus, it is imperative that we find solutions to these diseases or we may face a genuine epidemic. Excel Medical Clinical Trials (EMCT) is a National leader in studying disorders of fatty liver. We are proud to be on the forefront of efforts to potentially curtail or eliminate NAFLD and NASH.
Primary Biliary Cholangitis (PBC), formerly known as primary biliary cirrhosis, is a chronic liver disease that results from progressively slow damage to the bile ducts in the liver. Bile is produced in the liver and helps with the digestion of fat soluble vitamins (A, D, E and K). When bile ducts are damaged, bile builds up in the liver and contributes to inflammation and scarring (fibrosis); this can lead to irreversible damage of the liver tissue (cirrhosis). Risk factors include gender (more common in women), age (more common in people 30 to 60 years old), and family history. Excel Medical Clinical Trials (EMCT) is proud to conduct studies in PBC.
Statins are medications that remain the mainstay of lipid lowering therapy. Statins were first FDA approved in 1987; thus, they have a relatively long record of safety and efficacy. Still, many individuals cannot tolerate statins; these people have been dubbed, ‘statin intolerant.’ Because this problem is so common, a number of studies are being conducted to evaluate medications that may be effective in statin intolerant patients. Excel Medical Clinical Trials (EMCT) is proud to be conducting studies in statin intolerance as we hope to be a part of the potential discovery of medications that will help people lower their LDL levels and decrease their risk of heart attack, stroke and cardiovascular death.
Type 2 Diabetes
Diabetes Mellitus is a disorder involving the improper production or utilization of the pancreatic hormone, insulin. Approximately, 2.4 million Floridians suffer from diabetes. Diabetes can lead to many disorders such as kidney failure, peripheral artery disease and lower extremity amputations, neuropathies, blindness, stroke, heart attack and heart failure. We are always trying to find better solutions to treat diabetes. Clearly maintaining optimal weight, eating a healthful diet and exercising regularly are paramount. Often however, this is not enough; medications are needed. Excel Medical Clinical Trials (EMCT) is proud to conduct studies in the realm of diabetes. We hope to be a part of the movement to hopefully eradicate many of the complications of Diabetes Mellitus.