Clinical research at Iowa Heart Center
(To refer patients for clinical research studies, call 515-235-5096)
In order to provide access to the latest treatment advances, Iowa Heart Center is involved with many clinical research studies. Your patients may be asked to participate in these studies. While each is different, the following information is designed to help you understand the research process.
What is a clinical study?
In cardiology research, a clinical research study (or clinical trial) is designed to show how a new heart disease treatment or prevention strategy – a new pacemaker or cholesterol-lowering drug, for instance – affects the people who receive it.
A clinical study is part of the process in evaluating a new drug, device or other means of treating heart disease. Once a new treatment has shown promise in the laboratory and in animals, it may be used in people.
Applicable studies are approved by the FDA. If a new treatment proves itself to be both safe and effective in treating heart disease, it may then be approved for widespread use.
Types of clinical studies:
Prevention studies look at lifestyle changes or drugs that may help prevent heart disease, or reduce further problems. One recent study, for example, examined using drugs approved for hypertension to prevent a second heart attack.
Diagnostic studies look for new ways to detect heart disease, or to determine the severity of the disease. magnetic resonance imaging (mri), for example, is being evaluated at some institutions as a new tool in the detection of aortic aneurysms.
Treatment studies examine new drugs, devices or other treatment options, or test combinations of current treatments. These types of studies fall into three categories:
· Phase I studies test the safety of a new treatment.
· Phase II studies examine the effectiveness of the treatment against heart disease. in drug studies, the optimal dose is also determined.
· Phase III studies, which are typically larger and involve many patients at many locations, compare the new treatment to the current standard.
Benefits of participating in a study
The advantage of participating in a clinical study is the possibility that a new treatment option will be better than currently available options. It is also an opportunity to make a lasting contribution to cardiovascular research. In phase III studies, patients receive either the most advanced treatment currently in use, or another thought to be even better.
Study participants receive expert care according to detailed specifications, known as a protocol. All patients are carefully monitored during and after the study.
Are patients safe?
Clinical research studies are carefully reviewed for medical ethics, safety and scientific merit. An institutional review board, or IRB, located at the study site, reviews each study before it begins. The IRB also ensures that all patients make an informed decision to participate. Several organizations, including the IRB, the FDA and pharmaceutical companies, regularly review each study.
For more information on clinical research opportunities at Iowa Heart Center, or to refer a patient for a clinical research study, call (515) 235-5096.
