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Coronary Artery Disease

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Coronary Artery Disease Clinical TrialsGeneral Purpose:

Coronary heart disease (CHD), also referred to as coronary artery disease or CAD, occurs when plaques build up inside the coronary arteries, which supply blood to the heart. This build up of plaque is commonly referred to as atherosclerosis, and it occurs gradually over the course of many years.

Eventually, atherosclerosis causes the coronary arteries to harden and narrow, which gradually begins to limit the flow of blood to the heart. When these plaques grow large enough they can rupture, causing a clot that can grow large enough to completely block the flow of blood through the affected artery.

Coronary artery disease can result in angina, heart attack, heart failure and abnormal heart rhythms. Due to its severe potential consequences, and the fact that it is the number one cause of death for both men and women in the United States today, there is an abundance of research devoted to improving the prevention, diagnosis, and treatment of CHD.

 What Will Coronary Artery Disease Clinical Trials Be Like? 

The types of tests and assessments used in coronary artery disease clinical trials will ultimately depend on the specific nature of the study and what aspects of CHD are being investigated. Provided below is a list of frequent procedures and tests used to evaluate theCoronary Artery Disease Clinical Trials heart, heart functioning, and its impact on the body in general, many of which may be incorporated for use in clinical trials:

  • Detailed physical exam and medical history
  • 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.
  • Chest x-ray
  • 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. A specific type of CT scan, known as electron-beam computed tomography (or EBCT) is often used to look for calcium deposits in the walls of the coronary arteries, which are an early sign that CHD may be present.
  • 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. This allows doctors to view the insides of the arteries that provide blood to your heart. Angiography may also be used to evaluate other blood vessels throughout the body.
  • 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. During a procedure known as transesophageal echocardiography, a long, thin ultrasound probe is guided down the throat into the esophagus, which is directly behind the heart, in order to obtain more detailed pictures.
  • Electrocardiogram (EKG, or ECG): a straightforward and painless procedure that records the electrical activity of the heart. This test tells doctors how fast your heart is beating, the regularity (or irregularity) of your heart rhythm, and strength and timing of the electrical signals that constantly pass through the heart.
  • 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.
  • Blood tests to check levels of various fats (lipids/triglycerides), cholesterol, sugar, and proteins.
  • 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 exercise diaries, may also be required in some studies, depending on the research question being studied.

Typical Protocol for Coronary Artery Disease:

 Specific examples of clinical trials for coronary artery disease might include the following:

  • A study to determine if individuals with periodontal disease (disease of the bones and gums surrounding the teeth) and positive oral tests for specific periodontal-disease Coronary Artery Disease Clinical Trialscausing bacteria, are at an increased risk of suffering heart attack, stroke, or death due to coronary artery disease over a one-year period.
  • A study to determine if women who have previously suffered a heart attack show decreased thickening of plaques in their carotid arteries following treatment with a nutritional supplement that contains lycopene (an extract of tomatoes).
  • A long-term, randomized clinical trial that compares standard cholesterol-lowering drug treatment plus the addition of a new drug to standard cholesterol-lowering medication plus a placebo to determine which is more effective at preventing angina, heart attack, heart failure, and abnormal heart rhythms among patients with coronary artery disease.
  • A randomized study to determine if standard treatment for depression plus a new psychotherapy technique is more effective at improving depressive symptoms and quality of life among coronary artery disease patients than standard treatment for depression alone.

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, such as the fourth clinical trial example given above.

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 third clinical trial example Coronary Artery Disease Clinical Trialsprovided 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, including your history of coronary artery disease, treatment history, and a variety of clinical findings. 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 prior history of heart disease and any current heart disease diagnoses
  • Your prior history of treatment for heart disease (including any surgeries, procedures, and medications)
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels

Suggested Search Terms: 

Once you are ready to begin your search for clinical trials, the following search terms may be of use when combined with the phrase “coronary artery disease clinical trials”: “rehabilitation,” “risk factors,” “men,” “women,” “prevention,” “treatment,” “depression,” “exercise,” “quality of life,” “diabetes,” and “obesity.”

Current Search Term:

“coronary artery disease”

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