Clinical trials are medical research studies aimed at evaluating new ways of diagnosing, treating, or preventing a disease. Researchers use clinical trials to determine if a new treatment is safe and effective for people. Cardiovascular clinical trials look specifically at new treatments for heart issues.
If rigorous research studies prove these treatments or devices are safe and effective, the Food and Drug Administration allows them to become available for use in patients.
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Why Participate in Clinical Trials for Heart Disease?
Clinical trials can offer hope for participants and other heart patients. Furthermore, enrolling in a heart study means gaining access to the newest treatment, as well as personal attention and care from a dedicated team.
Before deciding to enroll in a clinical trial, you should discuss the exact risks of the study with its research coordinator and your doctor. The National Heart, Lung, and Blood Institute recommends weighing the level of harm that could occur while participating in a clinical trial against the level of harm that could occur if you don’t participate. For some patients, the benefits may outweigh the risks.
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How Clinical Trials Work
Typically, cardiovascular clinical trials have four phases:
- Phase I: Begins with experimental treatment on a small group of healthy people to assess safety. According to the National Institute on Aging, 20 to 80 people is the typical sample size for Phase I.
- Phase II: Involves using more people, sometimes up to 300, to see if the treatment is effective.
- Phase III: Focuses on gathering more information about safety and effectiveness within different populations, sometimes using the new treatment in conjunction with other known drugs. If the treatment appears safe at this time, the FDA will approve it.
- Phase IV: Researchers monitor the effectiveness of the treatment over time within large, diverse populations. Clinical trials can continue for more than five years.
Currently, over 286,000 clinical trials are ongoing in the United States and in 204 countries, according to Clinical Trials.
Why Clinical Trials Are Important for Cardiovascular Care
Doctors, surgeons, and clinicians generally use clinical trials to explore new technologies that have the potential to improve treatments for heart and vascular patients. These studies also help our health care teams learn more about the causes of heart disease.
Finally, they help us understand the genetics of heart disease, which also could lead to new therapies.
Contact the UPMC Heart and Vascular Institute at 1-855-876-2484.
The UPMC Heart and Vascular Institute has long been a leader in cardiovascular care, with a rich history in clinical research and innovation. As one of the first heart transplant centers in the country and as the developer of one of the first heart-assist devices, UPMC has contributed to advancing the field of cardiovascular medicine.