Join Heart Disease Clinical Trials
Heart disease is a general term used to refer to a variety of conditions that adversely affect the heart, including coronary heart disease (also called coronary artery disease), abnormal heart rhythm (also known as arrhythmia), heart infections, and birth defects of the heart. Heart disease clinical trials generally focus on these areas.
Sometimes, the term “heart disease” is used interchangeably with the term “cardiovascular disease;” however, it is important to know that cardiovascular disease typically refers to conditions that are characterized by narrowed or blocked blood vessels, and therefore can pertain to any area of the body. Nevertheless, cardiovascular diseases most often lead to heart attack (also called myocardial infarction), chest pain (or angina), and/or stroke.
If you have been diagnosed with heart disease, you are not alone. Heart disease is the leading cause of death for both men and women. Hundreds of thousands of individuals in the United States are diagnosed with some form of heart disease each year, and millions more have significant risk factors that place them at an increased risk for developing heart disease.
In addition, heart disease places a substantial financial burden on our healthcare system. In 2010, coronary heart disease alone cost the United States nearly $110 billion for health care services, medications, and lost productivity due to illness.
Due to its widespread prevalence and significant impact on the United States health care system and overall economy, heart disease is one of the most widely-researched health topics in the United States and around the world. So, if you have received a diagnosis of heart disease, rest assured that scientists and researchers are hard at work studying new and improved ways to prevent, diagnose, treat, and even cure the multitude of heart diseases that occur.
What Will Heart Disease Clinical Trials Be Like?
The types of tests and assessments used in heart disease clinical trials will ultimately depend on the specific nature of the study and more importantly, which particular heart disease (or diseases) is/are being studied. Provided below is a list of frequent procedures and tests used to evaluate the heart, heart functioning, and its impact on the body in general, many of which may be incorporated for use in clinical trials:
- Physical exam
- Detailed family history of heart diseases.
- Genetic testing
- 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. 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 look for chemical markers that indicate the presence of heart disease. Examples of these markers include troponin, CK-MB enzyme, myoglobin, hs-CRP, and BNP or NT-proBNP, pH, oxygen, and carbon dioxide.
- Nuclear heart scan: a test that uses a small but safe amount of a radioactive compound, injected into your body through a vein in the arm. This compound then travels to the heart and allows special cameras to take detailed pictures of the heart to evaluate 1) blood flow; 2) damaged heart muscle; and 3) pumping ability and efficiency.
- 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 Heart Disease Clinical Trials:
Specific examples of heart disease clinical trials might include the following:
- An observational study to evaluate how pregnant women with heart disease are managed in terms of the anesthesia they receive during delivery (e.g., epidural, oral medications, general anesthesia).
- A study in which infants born with a particular heart defect are treated with a new drug prior to and following standard corrective surgery for the defect, to determine if use of the drug is effective at minimizing the risk of surgery-related brain damage.
- A randomized study to determine if a broad combination of behavioral interventions and medications is more effective at reducing the risk of new heart disease development and death in individuals who have already been diagnosed with a particular form of heart disease. In this study, the patients randomized to receive the combined interventions would be compared to a control group of heart disease patients who received only standard treatment for their heart disease. For additional information on randomized studies, please see the section immediately following this listing of sample clinical trials.
- A long-term study designed to evaluate new and potentially useful blood markers that are associated with the prognosis of patients with heart disease. In such a study, volunteers with heart disease would be required to give blood samples at specified intervals of time over the course of 12 months so that researchers could examine their blood for the presence of specific chemicals and compounds that might be associated with their long-term outcome.
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. 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 heart 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 specific diagnosis of heart disease (e.g., coronary artery disease, arrhythmia, mitral valve prolapse) – or – if you have not been diagnosed with heart disease but have been told you are at risk for developing it, it is important to know the specific risk factors that you have, such as obesity, smoking, or family history.
- Your prior history of heart disease.
- 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.
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