Cleveland_Clinic_Host: Welcome Dr. Gornik and Susan Stein and thank you for being with us today. Let's begin with one of the questions.

Speaker_-_Dr__Gornik: Thank you for having me. It is a pleasure to be here to speak about Research

Questions about Participating in Research: Safety

Cleveland_Clinic_Host: First question we get asked, is how do I know it is safe to be in a research trial?

Speaker_-_Susan_Stein: All of the risks and side effects of the treatment being researched are not known at the beginning of the clinical trial. Since this is the case, there may be unknown side effects, as well as hoped-for benefits. It is important to note that most treatments- as well as the disease or condition itself- have potential side effects. In clinical trials, most side effects from the treatment are temporary and go away once the treatment is stopped. Patients will be informed of any known possible side effects as well as any “new” side effects that occur while they are participating in the trial.

Questions about Participating in Research: Costs, Payments and Advantages

Cleveland_Clinic_Host: Lastly, do patients get paid to be in these studies? And if they do not get paid, what are they getting out of their participation?

Speaker_-_Susan_Stein: First of all you asked will participants get paid for participating in a research trial? Most studies do not pay for participating in the study. Some may provide a small stipend to reimburse for time or inconvenience to return for study visits. STUDY RELATED visits, tests and procedures, and study medications are normally paid for by the study sponsor.

Speaker_-_Susan_Stein: You then asked about what patients get out of the study participation. Participation in research does not guarantee benefits, but often times individuals who participate in research do have another pair of eyes watching over them, and often have more examinations and tests than are usually given for a particular condition. Your treatment costs may be decreased, since many of the tests and physician visits that are directly related to the clinical trial are paid for by the sponsor of the study.

tomk: If I qualify for a study at a hospital such as the Cleveland Clinic, does it pay for all my hospital stay and the surgery?

Speaker_-_Dr__Gornik: The answer is no. Most studies do not pay for participating in the studies. Regular clinical care procedures are charged to your insurance carrier. Some study related procedures and visits may be paid for by the sponsor. As always, this should be discussed in detail before you agree to participate in a research study.

Cleveland_Clinic_Host: As a wrap up to this interesting talk, we would like to ask Dr. Gornik and Susan one last questions. Why should a person consider enrolling in a research trial instead of following treatment suggestions from their doctor?

Speaker_-_Susan_Stein: Research participation is a personal decision. It allows some people access to new technology and or drugs that are not available to the general public, but does not guarantee the new treatment is better than what is currently available or even better than no treatment at all.

Speaker_-_Susan_Stein: Some people get a feeling of personal satisfaction by contributing to medical knowledge, by participating in medical research.

Speaker_-_Susan_Stein: The decision to participate in research should be discussed with your health care provider.

Questions about Participating in Research: Commitment - Time and Visits

Cleveland_Clinic_Host: Also, patients are usually wondering, what kind of commitment is involved when I am in a research trial?

Speaker_-_Susan_Stein: The time commitment and required visits and procedures involved in a clinical trial are spelled out in the Patient Informed Consent document. An Informed Consent document lists all the details of the study including risks, benefits, obligations of the sponsor and the participant.

Speaker_-_Susan_Stein: Each trial is different, so be sure to have all of your questions answered prior to participating.

Cleveland_Clinic_Host: How long to patients usually have to be in the trial?

Speaker_-_Susan_Stein: Each trial is unique, and the timeline for each trial varies.

Questions about Participating in Research: Study Findings and Results

Cleveland_Clinic_Host: Susan- do participants get to see the results of the trial they are involved in?

Speaker_-_Susan_Stein: Some trials provide the results to participants after the trial is completed and the data is analyzed and published. Again, all trials are different and it is up to the sponsor/Primary Investigator to determine if results are shared.

Cleveland_Clinic_Host: To go along with results, will patients see their lab results when in a study?

Speaker_-_Dr__Gornik: Many trials provide some, if not all lab results. However, if the main purpose of a clinical trail is to influence lab results (blood sugars, cholesterol, etc.), then the labs may be blinded during the actual treatment phase of the study.

Speaker_-_Dr__Gornik: Blinding means neither you nor the investigator will know the results.

Cleveland_Clinic_Host: Dr. Gornik--do you share patient information collected during a trial with the patient's primary care physicians?

Speaker_-_Dr__Gornik: Medical information obtained during a clinical trial that is pertinent to your health care will be included in your medical record, and if you give permission, sent to your Primary Care Physician. Blinded labs in a drug study will not be shared with you or your doctor.

Speaker_-_Susan_Stein: One more point regarding the last question. Extremely abnormal lab results will be sent to the primary investigator.

sue: A few years ago I signed up for a research study that looked at a diet supplement to lower your cholesterol. When you participate in a study do you ever get to find out what the outcome was?

Speaker_-_Dr__Gornik: That is a great question. In some studies participants are notified directly of findings. This should have been discussed when you consent to participate in the trial.

Speaker_-_Dr__Gornik: Other ways to learn about the findings of trials are by asking your physician, or looking at the website http://www.clinicaltrials.gov. You can also always contact the site where you were participating in research to find out if the findings were released.

pak70: Sometimes there are things in the news like how great drug coated stents are and then later they have information that they are not as safe? Then, some doctors agree and some do not. Why does that occur? Aren’t the results of a study clear cut? Don’t they test things like stents to find out if they are safe before they use them on people?

Speaker_-_Dr__Gornik: That is a very good question. Unfortunately, some research areas are very controversial, and there have been multiple studies which have yielded conflicting findings and no "right" answer. This is the case with the controversy surrounding drug coated stents, and multiple studies are ongoing that will hopefully find a definitive answer.

Speaker_-_Dr__Gornik: In these cases of controversy, sometimes the best place to look for guidance are national regulatory agencies, such as the FDA. And also consensus opinions from large groups of health professionals like the American Heart Association and the American College of Cardiology who have released public statements on drug eluting stents.

Questions about Participating in Research: Treatment, Randomization

joan: If you participate in a research study, does that mean you get the treatment. For example the percutaneous valve studies. If my mother participates in the trial and she is a candidate for treatment, can she for sure get the valve or do some patients get it and some patients don’t?

Speaker_-_Susan_Stein: Most trials are randomized. That means that it is like a flip of the coin to either conventional treatment or the new investigational treatment. There are some interventional studies in which all patients receive the experimental treatment, but are followed with a registry.

Speaker_-_Susan_Stein: It is important to check with the study staff as to the specifics of the trial you are enrolling.

Questions about Participating in Research: Find Out About Current Research

msd44: What is going on with stem cell research?

Speaker_-_Dr__Gornik: To my knowledge, we currently do not have stem cell trials ongoing at the Cleveland Clinic for heart or vascular disease. We have done these studies in the past but none are open to enrollment. There may be studies in the future at the Cleveland Clinic.

Speaker_-_Dr__Gornik: There may also be other trials running within the United States, as this is an active area of research. Go to http://www.clinicaltrails.gov and type in stem cell in the search bar.

maryanne: My husband had bypass surgery 4 years ago. Five bypasses. He seems like he has started to have symptoms again. How can you find out what type of studies are available to him?

Speaker_-_Dr__Gornik: The first thing that needs to be done is a re-evaluation by a cardiologist. He may have a simple problem that can be treated with readily available medications or procedures.

Speaker_-_Dr__Gornik: Your husband's cardiologist can make an assessment as to whether future participation in research is appropriate. Many clinical cardiologist are familiar with currently enrolling trials in the cardiovascular field. We would also be happy to see your husband at the Cleveland Clinic for the latest in current treatments as well as research studies.

marybeth: How do I find out if there is a research trial that might benefit me

Speaker_-_Susan_Stein: You can look at our website or you can go to http://www.clinicaltrials and do a search on the topic. This will give you studies available across the country

billoviatt: Do you ever conduct clinical trials with really advanced nutriceuticals - where hundreds of different antioxidants are scientifically combined with minerals, including a very powerful heart antioxidant coenzyme Q10??

Speaker_-_Susan_Stein: In the next few months we will be initiating a high fiber nutritional study for people with abnormal cholesterols. The idea is to increase HDL and decrease LDL.

Speaker_-_Susan_Stein: We have done other studies in the past with neutraceuticals and B complex vitamins.

tommyboy: Can I sign up for HDL Apo A1 Milano trials? Is there still promise to this treatment?

Cleveland_Clinic_Host: I would suggest you look at our chat transcripts with Dr. Steven Nissen. He discussed Apo A1 during his talk.

uncleerny: are there any new trials for heart failure anything we can try we are very desperate we are willing to do anything or go anywhere for trials my husband is only 57 he has heart failure diabetes and copd he has a pacemaker defibrillator he is a veteran but we also have insurance we can use for doctors and hospitals are there any new trials for the heart using stem cells? ARE THERE ANY NEW MEDICINES OUT THERE?

Cleveland_Clinic_Host: We have a Heart failure section here at Cleveland Clinic and we would suggest your husband make an appointment with one of our Heart Failure specialist. You can contact us through the "Contact Us" button on the website.

yru: Is Cleveland clinic doing research on bradycardia? I have a heart rate in the 40’s. My doctor says I need a pacemaker but I feel fine. Are there other treatments?

Speaker_-_Susan_Stein: If you are not symptomatic, you can have a second opinion evaluation with one of our electrophysiology physicians. Pacemaker procedures are much less invasive than in the past and involves only a one or two hour procedure, same day surgery.

patty: I had breast cancer several years ago. Now I need aortic valve surgery but I am told that I am at high risk due to the radiation I had. Could radiation cause a valve to go bad? Is there any research into the harmful affects of radiation?

Speaker_-_Dr__Gornik: Absolutely. This is an active area of clinical research. We are learning of long-term affects of radiation on the heart, including the coronary arteries, heart valves, heart electrical system, and lining of the heart, called the pericardium.

Speaker_-_Dr__Gornik: You may be interested in looking at a research study published within the past week by Dr. Donald Lloyd Jones at Jones LW et al. J Am Coll Cardiol 2007; 50:1435-1441 - do a search at http://www.ncbi.nlm.nih.gov/sites/entrez - the National Library of Medicine Website.

wmbrow: Are there studies that I can get into for uncontrolled high blood pressure. I am on maximum doses and still I have very high blood pressure

Speaker_-_Susan_Stein: Go to http://www.clinicaltrials.gov and type in high blood pressure in the search box. You will find studies nation-wide that may apply to you.

Kishuf_2: I am a writer researching your conclusions regarding angioplasty vs. medications for women. I am writing a story about my case, having a completely blocked heart artery, and resisting angioplasty for the last year by taking prescribed medications. Never had any palpitations since. What I need to know is, what has your current research and results on women with this condition shown regarding success rates of medication vs. angioplasty? What are some of the bad results after angioplasty on a very active senior? Would greatly appreciate your input and would like to quote you if you give it. thanks so much. cordially.

Speaker_-_Dr__Gornik: I am afraid I am not familiar with the specifics of the study to which you are referring, nor have I authored such a research project. We are participating in multiple clinical trials of interventional therapies for patients with coronary artery disease, including women.

emilyaviki: My question is about getting involved in cardiovascular research. I'm currently a second year medical student at Duke Med and am planning my 3rd year research project. I'd like to go abroad to conduct research. Are you aware of any international cardiovascular reserach organizations/opportunities?

Speaker_-_Dr__Gornik: It is great that you are interested in starting a cardiovascular research career. As a start, I would suggest talking to your research-oriented teachers and mentors at Duke to learn of their potential contacts in clinical research abroad. The website Clinicaltrials.gov can be very useful for identifying the types of research going on within a particular field. U.S. and foreign sites are listed, often with contact information. Good luck.

paf77: I read about chronic inflammation causing heart disease. Is there research into the treatment for this? If you have a lot of re-occuring disease in your coronaries, could it be related to an infection?

Speaker_-_Dr__Gornik: There is a known link between chronic inflammation and coronary artery disease. Many of the effective heart medications we have target inflammation, such as the statin drugs. Antibiotics were studied to treat inflammation and infection to prevent coronary events, but the results were disappointing.

Questions about Participating in Research: Discontinue Participation

Cleveland_Clinic_Host: Most patients are interested to know, what if a patient decides they do not want to continue the trial and wants to get out?

Speaker_-_Dr__Gornik: You may discontinue participation in a trial at any time. However, if you think you may not want to complete the trial at the beginning, it is better to not enroll at all.

smith66: What if you participate in research and they find during the research there are bad effects to the medication. Will they stop the study?

Speaker_-_Susan_Stein: Most studies have a data safety monitoring board that periodically reviews all ongoing study results. If findings find there are more risk than benefit, the study will be stopped based on pre-determined criteria.

Questions about Participating in Research: Sponsorship

billoviatt: Are drug companies the typical sponsors of cliniucal trials? I myself would have great concern for getting involved with any study having foreign chemicals to our bodies involved.

Speaker_-_Dr__Gornik: I think there are two issues that you raise. First of all, while pharmaceutical companies sponsor some research studies, many studies are funded from other sources, including the National Institutes of Health, Healthcare Foundations, and the American Heart Association.

Speaker_-_Dr__Gornik: The other issue you raise is discomfort with receiving an experimental medication. Many trials do involve research on new drugs, with the hope of identifying new treatments for heart disease. It should be clear however, that participation in research is ALWAYS voluntary. You should never participate in research if you are uncomfortable.

Vascular questions for Dr. Gornik

marybeth: My daughter, who is 23, has just been diagnosed with a "pseudo aneurysm" in an artery in her neck. Please help me understand what this is, what it means, and what treatments are used for it.

Speaker_-_Dr__Gornik: As a vascular medicine specialist, I would be concerned that your daughter may have an artery disorder. Psuedo aneurysm is a defect in the artery wall that can be caused by trauma or a tear or dissection to the artery. There are many vascular conditions that can cause carotid pseudo aneurysm and this should be evaluated.

Speaker_-_Dr__Gornik: She should be evaluated by a vascular specialist. That is one of my specialties and clinical interests. Can you contact us offline to arrange for a referral or arrange for her to be seen for a visit - use the contact us button on the page.

rong88: Is carotid artery stenting still research? Is it successful?

Speaker_-_Dr__Gornik: Unfortunately in many situations, the only way to gain access to carotid stenting is through participating in a research registry. Some of the carotid studies are really registries where all eligible patients undergo the procedure and are followed to see how they do. These registeries do not require a coin flip to allocate to placebo.

Speaker_-_Dr__Gornik: In certain cases, carotid stents are clinically available without participation in research, but this has been limited by insurance companies, medicare and the FDA.

Speaker_-_Dr__Gornik: Today the FDA is meeting to discuss the future of carotid stenting and you may see something about this in the news.

Cleveland_Clinic_Host: I'm sorry to say that our time with Dr. Gornik and Susan is over. Dr. Gornik and Susan, thank you again for taking the time to answer our questions today.

Speaker_-_Dr__Gornik: Thank you for having me.

Speaker_-_Susan_Stein: Thank you.

Cleveland_Clinic_Host: If you would like more information regarding participating in research, please visit the Cleveland Clinic Heart and Vascular Institute web site at www.clevelandclinic.org/heart or www.clinicaltrials.gov . For general health information you may also wish to visit www.clevelandclinic.org/health

© Copyright 2007 The Cleveland Clinic Foundation. All rights reserved. rev.6/07