Research

St. Luke's Cardiology Associates A Clinical Research Department

Our practice is pleased to have an extremely active Clinical Research Department. The members of our research department include:

• William Short, M.D., F.A.C.C., Principal Investigator
• Peter Kuhlman, M.D., F.A.C.C., Sub Investigator
• Julius Dean, M.D., F.A.C.C. , Sub Investigator
• Melody Thompson, R.N., B.S.N., C.C.R.C., Director of Research
• Tracey Bride, C.C.R.P., Certified Clinical Research Coordinator
• Maria Castro, C.M.A., Clinical Research Assistant
• Priscilla Pickett, Regulatory Affairs Coordinator

We are currently enrolling patients for studies in the following areas:

• Osteoarthritis or Rheumatoid Arthritis

• Angina in Women

• Heart Disease in Women

• Cardiovascular Disease with Abdominal Obesity

Upcoming studies include:

• Acute Coronary Syndrome
• Hypertension
• Heart Failure with Renal Insuffiency
• Congestive Heart Failure (CHF)
• Hypercholesterolemia

A clinical trial (also referred to as clinical research) is a research study comprised of human volunteers that assist in finding answers to specific health questions. Carefully conducted clinical trials are the fastest and safest way to find successful treatments that result in improved health. Two types of clinical trials are; Interventional trials which determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments and Observational trials which address health issues in large groups of people or populations in natural settings.

Frequently Asked Questions

Why Should I Participate in a Clinical Trial?

Participants in a clinical trial can play a more active role in their own health care, gain access to new research treatments before they are widely available and help others by contributing to medical research.

Who May Participate in a Clinical Trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to ensure reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”.

What Happens During a Clinical Trial?

Our clinical trial team carefully examines the health of each participant at the beginning of the trial and will explain specific instructions for participating. We continue to monitor the participant very closely during the course of the study and stay in touch after the trial is completed. Some clinical studies will involve additional testing and doctor visits than the participant would normally have. Clinical trial participation is most successful when there is close and frequent contact between participants and members of our clinical trial team.

What is Informed Consent?

Informed consent begins the process of learning the main facts regarding a specific clinical trial before the participant decides whether or not he/she wishes to participate. To help in this decision, the research team will explain the study details by providing an informed consent document that will outline the purpose of the study, duration, required procedures, key contacts, the risks involved, as well as, potential benefits. The participant then decides whether or not to sign the document.

How is the Safety of the Participant Protected?

The ethical and legal codes that govern a medical practice also apply to clinical trials. Most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol; a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.

Can a Participant Leave a Clinical Trial after It Has Begun?

Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should notify the research team and the reasons he/she wishes to discontinue the study.

Who Sponsors Clinical Trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as; physicians, medical institutions, foundations, voluntary groups, pharmaceutical companies, federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veterans' Affairs (VA). Trials can take place in a variety of locations, such as; hospitals, universities, doctors’ offices, or community clinics.

What is a Placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatments' effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.

If you are interested in learning more about St. Luke's Cardiology Associates A's current or upcoming clinical trials, please contact our Research Department at:

(904) 296-0278 extension 236