Regional Doctors Help Medical Science

Medical history is being helped along by some cardiologists and their patients at Washington Regional Medical Center.

Drs. James Cooper, David Churchill, Ted Fish and Harrison Butler are among the physicians participating in clinical trials that are required before new drugs and devices are approved as standard treatment for particular conditions.

They are part of an international network of cardiovascular physicians that has perfected the technique of collaborative studies in which doctors, hospitals, patients and others in six countries take part in the testing.

Since 1991, some 145 patients have taken part in the trials at Regional. At least one drug they’ve tested has since become part of the standard treatment for certain patients.

And Regional’s physicians aren’t the only ones taking part in various trials. Fayetteville Diagnostic Clinic, for example, marks its fourth year of participating in clinical trials this month. Treatments for diabetes, gastrointestinal disorders and arthritis are among the studies the clinic has helped study during that time.

International network

At Regional, studies have been done in cooperation with Duke University, Cleveland Cardiology Clinic, University of Washington, the Mayo Clinic and the New England Medical Center.

Anne Courtney-Eighmy, a registered nurse who works as the hospital’s clinical research manager, explains that many of the studies are part of an international network, Virtual Coordinating Center for Global Collaborative Cardiovascular Research. More commonly referred to as the VIGOUR Clinical Trials, the network includes physicians from six countries.

Dr. Fish and Dr. Butler took part in the original 1991 study, called GUSTO (for Global Utilization of Streptokinase and t-PA for Occluded coronary arteries), that, ultimately became a cornerstone in cardiovascular medicine, Courtney-Eighmy says. It was so important — and successful — that once the first study was completed in 1992, the group wanted to continue with other trials, she explains.

The GUSTO study compared two clot-busting drugs to determine which was better for heart-attack patients, Courtney-Eighmy explains.

One was Streptokinase, a drug that occurs naturally in the body to break down blood clots but which can be made artificially. The other was Activase, a so-called second-generation of Streptokinase.

The study found better results from the use of Activase, Courtney-Eighmy says, and that drug is now used across the country for patients who are admitted while suffering heart attacks or strokes.

Dr. Philip Duncan, Regional’s vice president of medical affairs, says the study was an example of a research project that became a standard of care. He is enthusiastic about the participation of the hospital and the physicians in such studies.

“It’s unusual and has been very uncommon for community institutions to participate” in such studies, he says. Historically, such studies were limited to academic medical centers. A study might take years to complete when it’s limited to a single institution. When it’s finished, “It’s theirs and no one else’s,” Duncan adds.

Collaborative research involves many institutions, doctors and patients, which leads to faster conclusions, Duncan says.

“I think it’s exciting and remarkable that a community hospital can participate” in such studies,” he says.

Since GUSTO, Regional and its cardiologists have helped in additional studies for other thrombolytic or clot-dissolving drugs. In ASSENT (for Assessment of the Safety and Efficacy of a New Thrombolytic agent), one drug was administered for the first time in North America at Washington Regional, says Courtney-Eighmy.

At Fayetteville Diagnostic Clinic, Patsy Bradley works with patients and physicians involved in clinical trials. Bradley, a registered nurse, says the most difficult part of the trials is recruiting patients, each of whom must meet specific criteria. It’s a time-consuming chore, but it’s vital that patients be carefully selected so their results are included in the study.

She finds some potential patients by combing through medical charts at the clinic. Others may be referred by their physicians.

The trials are beneficial to patient and physician alike, Bradley says. Participation “really will build a physician’s [curriculum vitae],” she says. It “puts them on the cutting edge” of their specialties.

For patients, there may be free medication or care. Some of the drugs tested at Regional, for example, are quite costly. In the ASSENT study, one dose of the tested drug may cost $1,800 to $2,000, Courtney-Eighmy says.

Patient identification

Finding participants for many of Regional’s studies is even more difficult because, often, they require administering a drug to a patient in distress, either with a heart attack or a stroke.

When a heart-attack patient comes into the emergency room, the attending physician immediately begins evaluating the situation and determines whether a clot-dissolving drug may be required, Courtney-Eighmy says. If the patient appears to be a suitable candidate, then the cardiologist is brought in, and the patient’s family is consulted.

The process — and the decision whether to participate — must be done fairly quickly, she says, because the longer a heart attack goes on, the more heart muscle is damaged.

The time element isn’t true for all of Regional’s studies, however. The latest trial, The Prevention of Sudden Cardiac Death in Heart Failure Trial, or SCD-HeFT, gives patients two or three weeks to decide.

SCD-HeFT is for patients with congestive heart failure, a condition with which, currently, one of five patients dies within 2 1/2 years of diagnosis.

Dr. James Cooper, a cardiologist and electrophysiologist, is Regional’s principal investor in the trial. SCD-HeFT is the first for Regional that has included the National Institutes of Health.

For Fayetteville Diagnostic Clinic, most of its studies are Phase III trials in which the particular drug already has been approved by the Federal Drug Administration for some use. The object of the study is to find additional uses for the drug, Bradley says.