Join Clinical Trials for High Cholesterol
Cholesterol, in adequate amounts, is actually a good thing. This wax-like substance is necessary for the body to produce healthy cells and is essential for the proper functioning of every organ in the human body. However, too much of a good thing can be bad, and that’s exactly what happens when the body has more cholesterol than it needs and this is where clinical trials for high cholesterol begin.
High cholesterol levels lead to the buildup of fatty deposits in the blood vessels, which ultimately make it hard for blood to flow properly through the arteries. This creates a trickle-down effect, depriving the heart and/or brain of blood, and subsequently increasing the risk of heart attack and/or stroke.
There are three types of cholesterol: low-density lipoprotein (LDL); very-low density lipoprotein (VLDL); and high-density lipoprotein (HDL). In addition, a type of fat found in the blood that is also associated with an increased risk of heart disease is triglycerides.
Triglyceride measurements are often used to estimate the amount of VLDL in the blood, as VLDL is difficult to measure accurately. On a basic level, VLDL and LDL, are considered “bad” cholesterol, whereas HDL is the “good” cholesterol.
Generally speaking, when all forms of cholesterol are measured together (known as total cholesterol), a diagnosis of “high cholesterol” is in order when readings are 240mg/dL and above. Ideal readings are below 200mg/dL.
An ideal triglyceride level is less than 150 mg/gL. If you have been told that you have hyperlipidemia, it generally means that you have high cholesterol and high triglycerides.
Although some individuals are more likely to develop high cholesterol due to their family history and certain genetic factors, others develop the condition simply as a result of poor diet and physical inactivity, among other things.
Fortunately, high cholesterol can be both prevented (in some people) and successfully treated/managed (in most people), through improvements in diet, exercise, and the use of medications.
Due to its association with heart disease, and its overwhelming prevalence in the United States and elsewhere, cholesterol has been a subject of intensive research for decades. Since it has been firmly linked to the development of atherosclerosis, research continues to focus on new and better ways to lower cholesterol and treat arterial damage even after it occurs.
Genetic research related to cholesterol is also in abundance, with scientists continually studying various genetic diseases and mutations that are known to lead to high cholesterol levels. In addition, other researchers are hard-focused on improving awareness of, and adherence to, behavioral and lifestyle factors that can prevent, as well as help to treat, high cholesterol.
What Will Clinical Trials for High Cholesterol Be Like?
The types of tests and assessments used in high cholesterol clinical trials will ultimately depend on the specific nature of the study and if other conditions, such as certain types of cardiovascular disease, are also being studied. Provided below is a list of frequent procedures and tests used to evaluate the heart, lungs, and blood vessels, many of which may be incorporated for use in clinical trials:
- Physical exam
- Blood pressure evaluation (using an inflatable blood pressure cuff and pressure gauge).
- Blood tests to measure the amount and types of cholesterol and triglycerides in the blood, as well as other substances such as blood sugar, and substances that indicate how well the liver and kidneys are functioning.
- Detailed family history of heart, cardiovascular disease, and high cholesterol.
- Genetic testing
- Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
- If the study is evaluating aspects related to a particular type of heart disease, the following tests and procedures may also be utilized:
- Cardiac catheterization: a procedure during which a long, thin, and flexible tube (i.e., catheter) is inserted into a blood vessel in the arm, upper thigh, or neck and threaded through until it reaches your heart. This allows doctors to perform diagnostic tests and treatments, as well as to evaluate blockages in the blood vessels.
- Computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans: these are non-invasive imaging procedures, similar to an x-ray, that allow doctors to take detailed pictures of your heart.
- Coronary angiography: a procedure during which a dye is injected into a vein in your arm and then viewed using a special x-ray machine, CT scanner, or MRI machine.
- Echocardiography (“echo”): a painless procedure that uses ultrasound to create moving pictures of your heart, which allow doctors to see its size, shape, and how well it is working.
- Electrocardiogram (EKG, or ECG): a straightforward and painless procedure that records the electrical activity of the heart.
- Stress test: a test performed while you exercise (usually by walking or running on a treadmill, or pedaling a stationary bicycle), which allows doctors to evaluate how your heart works during episodes of physical stress.
- Pain and quality of life assessments, as well as diet, exercise and/or medication diaries, may also be required in some studies, depending on the research question being studied.
Typical Protocol for Clinical Trials for High Cholesterol:
Specific examples of clinical trials for high cholesterol might include the following:
- A long-term observational study in which healthy volunteers provide blood samples for genetic analysis. In such a study, the blood samples would be analyzed to identify and characterize various genetic mutations and other factors that are known to be associated with the development of high cholesterol. All participants would be followed over ten years to see who did and did not develop high cholesterol and what (if any) correlation there was to those individuals’ genetic analysis.
- A randomized clinical trial to determine if standard drug treatment for high cholesterol plus a new cholesterol-lowering drug is more effective than standard treatment plus placebo.
- A randomized clinical trial to determine if standard drug treatment for high cholesterol plus a 12-week supervised exercise intervention is more effective at a) reducing cholesterol levels and b) improving quality of life than standard drug treatment alone.
- A study conducted in pediatric and adolescent patients with an inherited disorder that causes high cholesterol to determine if the use of a new drug is safe, effective, and well-tolerated. A study such as this might use healthy siblings of the patients to serve as controls in order to compare specific findings from the study.
A brief word about randomized trials and placebos:
Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.
On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the second clinical trial example given above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.
Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.
In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.
It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.
It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.
Trial Eligibility and Medical Information Needed:
The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:
- Your most recent total cholesterol level.
- Your prior history of heart disease and high cholesterol.
- Your family history of heart disease and high cholesterol.
- Your prior history of treatment for high cholesterol and/or heart disease (including any surgeries, procedures, and medications).
- Your current medications (including aspirin), vitamins, and dietary supplements.
- Your most recent blood pressure reading.
Suggested Search Terms:
Once you are ready to begin your search for clinical trials, the following terms may be helpful when combined with the term “high cholesterol”: “management,” “treatment,” “prevention,” “genetics,” “family history,” “pediatric,” “risk factors,” “obesity,” “diabetes,” “exercise,” and “heart disease.”
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