Join Clinical Trials for Stroke
A stroke occurs when blood flow to a portion of the brain stops. This blockage of blood flow – even for a few seconds – can result in oxygen deprivation to the cells and ultimately cause irreversible damage. Generally speaking, there are two types of stroke: ischemic stroke and hemorrhagic stroke.
Ischemic stroke results when a blood vessel that supplies blood to the brain becomes blocked by a clot. These types of stroke often occur when arteries are clogged with fat or cholesterol. Hemorrhagic strokes occur when blood vessels in the brain are weakened and burst open.
Transient ischemic attacks, or TIAs, are often referred to as “mini-strokes. “While they are similar to stroke and produce comparable symptoms, they generally last only a few minutes and result in no permanent damage. However, they are often considered to be warning signs of an impending stroke, and when detected, present an opportunity for prevention.
Unfortunately, stroke is very common in the United States. It is the third leading cause of death, claiming over 140,000 lives each year. There are a multitude of risk factors for stroke, however, many of them are treatable and even preventable.
The leading risk factor for stroke is high blood pressure. Other major risk factors include atrial fibrillation, diabetes, a family history of stroke, high cholesterol, age (in particular age greater than 55), and race (African Americans are more likely to die of stroke).
In addition, conditions such as peripheral artery disease, obesity, and alcoholism, as well as behaviors such as poor diet, smoking, and cocaine use are also associated with an increased risk of stroke.
Due to its widespread prevalence, high mortality rate, and ability to be prevented, stroke is a source of considerable research in the scientific community. Scientists and doctors are currently investigating new methods of treating stroke, managing its risk factors, and managing the physical and functional complications that arise in the wake of stroke.
What Will Stroke Clinical Trials Be Like?
The types of tests and assessments used in stroke clinical trials will ultimately depend on the specific nature of the study and if other conditions, such as certain types of heart 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, including listening to the carotid arteries (large arteries on each side of the neck) with a stethoscope.
- Blood pressure evaluation (using an inflatable blood pressure cuff and pressure gauge)
- Detailed family history of heart diseases and cardiovascular disease.
- Genetic testing
- Ultrasound of the carotid arteries.
- 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 brain.
- 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. This can also be used to help doctors determine if the stroke may have been caused by a clot that originated from the heart.
- Electrocardiogram (EKG, or ECG): a straightforward and painless procedure that records the electrical activity of the heart and can help to show whether an abnormal heart rhythm caused the stroke.
- Blood tests to evaluate bleeding time, cholesterol and blood sugar, tests of blood clotting, and measures of blood cells.
- 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.
- 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 Stroke Clinical Trial Protocol:
Specific examples of clinical trials for stroke might include the following:
- A randomized clinical trial to determine if an adaptive, vigorous, individualized physical activity program is more effective than a less-vigorous group exercise program at improving the walking speed, overall mobility, balance, and quality of life among stroke survivors.
- A large observational study in which stroke patients donate blood and tissue samples for genetic analysis. In a study such as this, researchers might conduct the genetic analysis to determine if there are certain genetic markers associated with a particular type of stoke (i.e., hemorrhagic versus ischemic).
- A randomized clinical trial to determine if standard treatment plus a newly developed drug is more effective at improving recovery after acute stroke than standard treatment plus placebo. Measures of improved recovery in a study such as this might include recovery of motor function, such as muscle strength, balance, and overall coordination.
- A study to evaluate a four-week education and support program for stroke caregivers to provide information regarding areas that caregivers find challenging. A study such as this would evaluate the effectiveness of the program by measuring its impact on the caregiver’s stress level, knowledge of caring strategies and community services, and overall quality of life.
- A clinical trial in which standard therapy with aspirin is compared to treatment with a new drug for the purposes of reducing the risk of stroke following an initial TIA. In a study such as this, patients in both groups would be followed for a period of months to determine the incidence of stroke and other cardiovascular events that occurred during that time.
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 third 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 specific history of stroke (i.e., hemorrhagic, ischemic, or TIA)
- Your prior history of heart disease and stroke
- Your family history of heart disease and stroke
- Your prior history of treatment for high blood pressure, heart disease, and/or stroke (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 stroke clinical trials, the following terms may be helpful when combined with either: “management,” “treatment,” “prevention,” “genetics,” “family history,” “risk factors,” “obesity,” “diabetes,” “heart disease,” “recurrence,” “rehabilitation,” “caregiver,” “exercise,” and “quality of life.”
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General Clinical Trial Information