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Medical research, trials conducted in our own backyard

New medical advances aren't solely the province of big urban or university hospitals. In smaller metropolitan areas like Lancaster and Harrisburg, research and clinical trials are resulting in improved treatments for heart patients.

New medical advances aren't solely the province of big urban or university hospitals. In smaller metropolitan areas like Lancaster and Harrisburg, research and clinical trials are resulting in improved treatments for heart patients.

"You usually think of Johns Hopkins and the Mayo Clinic as the places where cutting-edge research is being done," said Paul N. Casale, medical director of cardiology with The Heart Group at Lancaster General. "Many of us trained at these hospitals. We are being chosen to do these trials by sponsors who look at these credentials."

Those sponsors have included pharmaceutical companies, medical device companies and the National Institutes of Health.

At Lancaster General, research and clinical trials have focused on clogged heart arteries and ways to dissolve clots, electrical problems with the heart, heart failure, and prevention. The hospital works in conjunction with the Lancaster Heart and Stroke Foundation, a nonprofit charitable organization founded in 1993 that funds physician training and education and patient medical education. It has participated in more than 300 clinical trials involving more than 4,000 Central Pennsylvania residents. Approximately 25 studies are being done at Lancaster General, said LaRue B. McManus, executive director of the foundation.

The foundation also does community outreach and used proceeds from its clinical trials to purchase Automated External Defibrillators for Lancaster County police and ambulance vehicles. The cost of the donation was $550,000.

One of the advantages of conducting trials within the community is that local residents reap the benefits of the new medicine, device or treatment while it is being studied and receive more advanced care, said Seth Worley, medical physician with The Heart Group and a member of the foundation's board of directors. Trial participants are usually patients of regional doctors.

"The impact on the local community is much more immediate," Worley said. "It forces physicians to be current."

Earlier studies have worked on coatings of stents, discovering which medications were best to dissolve clots, and decreasing hospital readmission rates for congestive heart failure patients, Casale said.

"We are continuing to do studies that involve looking for medications that optimize treatment for coronary artery disease," Casale said. "We also continue to be involved in the evolution of stents and make them better."

Moffitt Heart and Vascular Group in Wormleysburg does most of its research and clinical trials at PinnacleHealth in Harrisburg. Its ongoing research includes examining heart attack patients, looking at different methods to open blocked arteries with stents or external ultrasounds, and ways to thin blood. Moffitt also participated in the trial that tested the Sirius Cordis drug-coated stent manufactured by Johnson & Johnson. The stent was approved by the Federal Drug Administration in 2003. Conducting the trial locally allowed patients to gain access to the new therapy three years before it was available on the market.

Finding trial participants is usually done with little fanfare. "Generally, people do not know," said William B. Bachinsky, medical director of the cardiac catherization laboratory at Moffitt. "Patients are identified through the doctors taking care of them. In general, physicians are not comfortable with advertising."

Moffitt also tested catheters and effects of cholesterol, and it conducted trials involving patients with structural heart disease and valve problems. Another trial conducted by Moffitt focused on the relationship between migraine headaches and holes in the heart.

The initial phases of a clinical trial involve making sure the drug is safe and the correct dose is being used. It is then sent to the hospital, where the trial may take one to two years, and the data collected.

"Usually the FDA would take three to six months until they rule on a drug," Bachinsky said. "Devices take three months to a year before being given FDA approval."

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