Changing the future of heart care - Today's research is tomorrow's medicine

Think of all of the medical advances we enjoy today that our parents and grandparents probably never dreamed possible - open heart surgery to open blocked arteries, pacemakers and implantable defibrillators to control irregular heartbeats, even cholesterol-lowering medications.

• The advantages of joining a cardiovascular research study
• Informed consent
• Randomized trials
• How new drugs are tested and approved
• Cardiovascular Research Trials

The research advantages we benefit from today are all possible because people before us were willing to test them out as volunteers in medical research studies. In an effort to continue advancing cardiovascular care, the Heart & Vascular Center at Christiana Hospital is actively involved in scores of current research studies. To continue with our progress, we need your help.

Want to help shape the future of cardiovascular care?
Christiana Care's Cardiovascular Research Program is currently looking for volunteers for a number of research studies. Ask your doctor if there's one that may hold the key for a better treatment for your cardiac condition. Not only could it help improve your own health, your participation could help shape the future of cardiovascular care for generations to come. Now that's a gift for your children and grandchildren!

To learn more, or to find out if you qualify for a cardiovascular research trial, call Christiana Care today at 302-733-2658 . What is medical research? A medical research study (sometimes called a clinical trial, research protocol or clinical study) expands our understanding of a disease. It helps doctors determine whether a new treatment is safe, effective and better than the current treatment method. Participating in a clinical trial does not make you a "guinea pig." In fact, by the time a new medication or treatment option is ready to be tested by patients, it has already passed rigorous government safety standards and is found to have merits as a potential new medical option. 

The advantages of joining a cardiovascular research study
If you have heart disease, being part of a research clinical trial may actually give you an advantage. You'll benefit from increased medical attention and support from doctors and nurses who are committed to finding new and better ways to prevent and treat heart disease. You may even qualify for free medical therapy. Many doctors find that, in general, their patients do better overall, both medically and psychologically, when they take part in scientific studies designed to evaluate a new treatment for their illness.

Benefits of joining a cardiovascular research study
Join a cardiovascular research trial and you'll reap lots of benefits:

• The very latest medicines or devices available to treat your condition.
• Frequent and thorough medical exams.
• The latest information to help you better understand your condition and the guidance you need to improve your health.
• Support and counseling from doctors and nurses on Christiana Care's research staff. What's more, you'll be making an important contribution to the future of cardiovascular medicine.

Christiana Care's Cardiovascular Research Program
Christiana Care Health System is regionally recognized as a major contributor to medical research, with more than 600 studies in as many as 15 clinical disciplines, from AIDS to cancer to cardiovascular disease.

Christiana Care cardiologists recognize that today's research could be tomorrow's medicine. Through research projects, doctors with varying specialties-cardiologists, cardiovascular surgeons, emergency medicine doctors, family practice physicians, radiologists and vascular specialists-find new ways to work together toward better treatments for all types of heart disease.  For more information call 302-733-2658 .

Current cardiovascular research studies
Christiana Care's Cardiovascular Research Program is a busy one, with dozens of research projects in progress on new treatments for heart attacks, congestive heart failure, blocked arteries, irregular heartbeats and high cholesterol. Studies include new techniques in cardiac catheterization and open-heart surgery, arrhythmia management, new therapies to reduce the damaging effects of heart disease, and the search for new ways to reduce pain and promote healing for heart patients.

In many nationwide studies, Christiana Care has been a recognized leader, both in enrolling significant numbers of study participants and in having research results published by our own cardiovascular physicians in world-renowned medical journals.

How to join a research study
To find out more about how you may benefit from a new medication or treatment available through Christiana Care's research program, ask your doctor or call the Cardiovascular Research office at 302-733-2658 . A research nurse will thoroughly review the trial with you, including:

• Its purpose.
• The type of treatment you'll receive.
• Any alternative treatments.
• The treatment schedule.
• Tests or monitoring involved.
• Possible side effects or risks.
• Possible benefits.
• Your obligation as a participant.
• Costs to you and/or your insurance company.

Informed consent
You will need approval from both your primary care physician and your cardiologist to participate in a cardiovascular research study. You will also be asked to give your informed consent. Your signature on the informed consent form says that you voluntarily agree, based upon adequate knowledge and understanding of relevant information about the trial, to participate in the medical research study.

Participation in any medical research trial is completely voluntary. If you do not wish to take part in a study, or if you decide to stop participating in the study at any time, know that your decision will in no way interfere with the quality of medical care you receive.

Randomized trials
In some research trials, participants are randomly assigned to a treatment plan. Randomization is like flipping a coin or pulling a number from a hat. You have an equal chance of being assigned to any of the treatment options being tested (or to receive a placebo, or sugar pill, instead of the drug being researched). Because medical research must be kept very scientific, you cannot pick which protocol you want to be assigned to in a randomized trial.

How new drugs are tested and approved
On average, it takes 15 years before a drug tested in the laboratory can be tested on humans. Only five in 5,000 compounds tested in the lab ever make it to human testing. Only one in five of those are approved for sale in the United States. After initial laboratory and animal studies, medicines that are tested in people must follow rigid guidelines set by the U.S. Food and Drug Administration (FDA). Medical research studies are categorized in four phases:

Phase I clinical trials involve healthy volunteers. These trials are designed to test a drug's safety and to determine how it works in the human body.

Phase II studies test the effectiveness of the drug on a few hundred volunteer patients who have the disease the drug is designed to treat.

Phase III trials involve several thousand volunteer patients who are closely monitored in clinics and hospitals to confirm the effectiveness of the drug in treating their illness and to identify any adverse effects.

Phase IV trials are sometimes required by the FDA to evaluate any long-term effects of a drug or treatment.

The cardiovascular research done by Christiana Care generally involves Phase II or Phase III trials with patient volunteers who have some form of heart disease. All studies are first approved by Christiana Care's Institutional Review Board (IRB), a special committee that reviews and oversees all research projects to ensure that participants' rights and welfare are protected.

Cardiovascular Research Trials

New studies are looking at ways to lower the risks of heart disease and stroke from just about every angle. Here are a few examples of the many Cardiovascular Research clinical trials in progress and open for enrollment. For more information call 302-733-2658 .

ZEUS: Testing a new cardiac imaging agent
Study Title: Open-Label, Phase 2 Study of the Safety and Efficacy of ß-Methyl-p-[123I]-Iodophenyl-Pentadecanoic Acid (Iodofiltic Acid I 123) for Identification of Ischemic Myocardium Using Single Photon Emission Computed Tomography (SPECT) in Adults with Symptoms Consistent with Acute Coronary Syndrome (ACS)
Principal Investigator:  Timothy Manzone, M.D.
An investigational drug (iodofiltic acid I-123) is being tested to help detect heart injury sooner in patients who come to the emergency department with chest pain. Current methods used to evaluate chest pain in the emergency department, including electrocardiograms and blood tests, do not provide enough information quickly to know if there has been any heart injury. Heart pictures taken with iodofiltic acid I-123, using a nuclear medicine technique called single photon emission computed tomography (SPECT), will be compared  to the final results of all the patient's tests to determine if the investigational drug is useful in detecting heart problems sooner than what is currently available.

Precision Study: Is one type of arthritis drug better for patients with cardiovascular disease?
Principal Investigators: Arthur Colbourn, M.D.
Co -Investigators: Mark Zolnick, M.D. and Michael Stillabower M.D.
Patients who have coronary heart disease or multiple risk factors are the focus of this worldwide study comparing the safety and efficacy of Celebrex (a COX-2 inhibitor) to Motrin (Ibuprofen) or Aleve (Naproxen), both of which are non-steroidal anti-inflammatory drugs or NSAIDs.. Participants will be randomized to receive one or the other of the study drugs to treat their symptoms of osteoarthritis, the most common form of arthritis. Patients with rheumatoid arthritis will also be included in the study.

AIM-HIGH Study - Can two drugs work better than one to promote healthy cholesterol?
Principal Investigator: Edward Goldenberg, M.D.
Co-Investigators: John Kelly, M.D., Michael Stillabower, M.D., and James Lenhard, M.D.
This study is comparing ZOCOR, a popular cholesterol medication, when taken alone or in combination with extended release niacin to lower the occurrence of heart attacks and stroke. Niacin has the ability to raise good cholesterol (HDL-C) and also may improve total cholesterol by reducing bad cholesterol (LDL-C) and triglycerides. Niacin also exhibits antioxidant, anti-inflammatory and other beneficial effects that could slow the processes that lead to blocked arteries that can cause heart attacks or strokes.

PLATO Study: Testing a new drug to stop dangerous blood clots.
Primary Investigator: Andrew Doorey, M.D.
Co- Investigators: James Hopkins, M.D., Gilbert Leidig, M.D., and Michael Stillabower, M.D.
Patients who have had a heart attack or who experience very severe chest pain are at high risk for forming blood clots and are often prescribed blood thinners such as clopidogrel (PLAVIX). This study is being carried out to see if an investigational medicine, called AZD6140, works as well or better than PLAVIX in stopping the formation of new blood clots.