I think there are two major reasons MHVI plays a significant role in leading cardiovascular research," says Dr. Jim Bengtson, cardiologist and Director of Research at MHVI.
"First, most of our physicians come from strong academic training programs with significant research experience. Second, we have a long and proven track record as participants in research studies. We were the leading enroller in a recently published international arrhythmia study as well as the second leading enroller in a national coronary stent trial."
Researchers have discovered a multitude of new therapies, but laboratory research alone is not sufficient. New treatments and prevention options cannot be widely used until they have been tested and proven. These tests, called clinical trials, are an essential part of the process involved in making new therapies available to the public. Each year thousands of patients volunteer to participate. Findings from these studies are used to refine treatments for heart and vascular disease. Early detection and innovative treatments enable patients to live longer, more active lives.
Michigan Heart & Vascular Institute offers the opportunity to participate in clinical trails. Major academic centers in and around the Ann Arbor area as well as pharmaceutical and cardiovascular equipment companies from across the world have partnered with the physicians of MHVI to conduct clinical trials at Saint Joseph Mercy Health System. Our physicians and staff have strong research backgrounds which enable them to participate in research. Many of the clinical trials have directly helped our patients by providing them with leading-edge medicines and/or technologies.
In the interest of our patients, we carefully evaluate each potential research project for the value it has to offer.
Research at MHVI:
Our goal is to link our patients with world-wide research groups. These links provide access to state-of-the-art cardiovascular treatment in our own community. All clinical research conducted through MHVI is reviewed and monitored by the Investigational Review Board at St. Joseph Mercy Hospital. The Michigan Heart & Vascular Institute is affiliated with Duke Clinical Research Institute, the Mayo Clinic, Cleveland Clinic, Cardiovascular Data Analysis Center, and several private sponsors.
FDA Approved Classifications of a Clinical Trial
Clinical trials at this phase evaluate the safety of new and unproven treatments. A small number of healthy volunteers or patients who have diseases that do not respond to standard therapy participate in these trials.
This is the "dose ranging" stage. The effectiveness of new drugs and devices is proven. Participants are very closely monitored for any adverse reactions.
At this stage new drugs and devices are compared to standard therapy for efficacy. Only those treatments found to be potentially superior to the standard are tested.
At this phase, drugs and devices that already have FDA approval are tested for expanded use.
Your participation in research is strictly voluntary. Some studies only offer benefits for future patients. In other cases, there are times when participating in a clinical trial may represent your best treatment choice.
Participating in a Clinical Trial
Benefits to You
As a member of a clinical trial, you may have access to new treatments not otherwise available. You will be closely monitored and often receive more attention than you would if you were a patient undergoing standard treatment.
Benefits to Others
The benefits of clinical trials cannot be overestimated. Your participation contributes directly to the knowledge base of medical science. Future patients will have access to safe, effective treatments because of today's research.
Ask your doctor about a clinical trial. As with current treatments being prescribed, there is often an element of risk.