Aneurysm

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Clinical Trials for Aneurysm

General Purpose:

Aneurysms are a ballooning in the wall of an artery, and occur most often in the aorta. The aorta is the main artery that runs through the body, traveling from the heart through the chest and then down into the abdomen.

Aortic aneurysms often occur in the region of the chest or abdomen. However, aneurysms can also occur elsewhere in the body, such as the heart itself. In addition, aneurysms in the brain (also called cerebral aneurysms) commonly occur as well. Individuals may be born with cerebral aneurysms, or they can result from trauma, high blood pressure, infection, cancer, and cardiovascular disease.

Finding out that you have an aneurysm can be a frightening experience, for the simple fact that if an aneurysm bursts it can result in severe bleeding or even death. For example, if an aneurysm in the brain bursts it results in a stroke.

Fortunately, if aneurysms are detected early enough they can be successfully treated with the use of either medication or surgery. Additionally, researchers are hard at work investigating new methods of detecting and treating aneurysms, as well as looking at genetic patterns to better identify groups of individuals who may be at an increased risk of developing brain aneurysms.

What Will Aneurysm Clinical Trials Be Like?

The types of tests and assessments used in aneurysm clinical trials will ultimately depend on the specific nature of the study and what aspects of aneurysms are being investigated. Provided below is a list of frequent procedures and tests used to evaluate cardiovascular Clinical Trials for Aneurysmdisease in general, many of which may be incorporated for use in clinical trials:

  • Physical exam
  • 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 and blood vessels.
  • 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.
  • Abdominal ultrasound (to evaluate abdominal aortic aneurysms).
  • 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. A sample of spinal fluid may also be analyzed.
  • 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 Aneurysm Clinical Trial Protocol:

Specific examples of clinical trials for individuals with aneurysms might include the following:

  • A study to investigate if supervised aerobic exercise among individuals with small abdominal aortic aneurysms (less than 50 millimeters in diameter) is safe and beneficial.
  • A clinical trial to compare a newly approved catheter-implanted device for treating aneurysms with standard treatment (using catheter-implanted platinum coils) to determine if the new device is as effective as standard treatment at preventing aneurysm recurrence.
  • A clinical trial to compare the use of two different blood pressure-lowering medications to determine if one is more effective than the other at a) decreasing the inflammation associated with small aortic aneurysms and b) shrink the diameter of the aneurysm.
  • A randomized trial that involves the use of a new medication compared to a placebo for use in preventing the development of cerebral vasospasm (decreased blood flow to and from the brain) following rupture of a brain aneurysm. A trial such as this (i.e., in which patients have the chance of receiving a placebo, or inactive treatment) is only done when there is no standard therapy available for the condition being studied. In this example, no standard therapy exists for the prevention of cerebral vasospasm. The following text provides additional information regarding randomized trials and placebos:

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 Clinical Trials for Aneurysminvestigational 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, such as the fourth clinical trial example provided above, 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 medical history and a variety of clinical findings. Therefore, it is important to know asClinical Trials for Aneurysm many details as possible related to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • The specific location and size of your aneurysm.
  • Your prior history of heart disease and aneurysm.
  • Your prior history of treatment for heart disease (including any surgeries, procedures, and medications) and aneurysm.
  • Your current medications (including aspirin), vitamins, and dietary supplements.
  • Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels.

Suggested Search Terms:

 “aortic aneurysm,” “abdominal aortic aneurysm,” “cerebral aneurysm,” “aneurysm repair,” “aneurysm medication,” “aneurysm surgery,” and “aneurysm surgery.”

Current Search Term:

“Aneurysm”

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