The Clinical Research Experience at KentuckyOne Health Cardiology Associates
What is a clinical research trial?
What can I expect if I decide to participate in a research trial?
What is Informed Consent?
What happens during the clinical trial?
What happens after the clinical trial ends?
What types of studies are done at KentuckyOne Health Cardiology Associates?
Current Research Trials that are in progress at KentuckyOne Health Cardiology Associates
Our mission is to provide opportunities for our patients to participate in cutting edge cardiovascular research, which provides access to therapies that may not be available to the general public. The Foundation strives to assist in the development of new and safe medications and devices to fight heart disease.
Over 900 of our patients have participated in over 100 trials that have been conducted by KentuckyOne Health Cardiology Associates.
Clinical research trials at KentuckyOne Health Cardiology Associates are conducted by our physicians and research nurses, in conjunction with other departments in our practice such as the Pacemaker, Lipid, Coumadin, Echocardiography Clinics as well as local Hospitals.
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A clinical research trial or study is a carefully designed plan that seeks to answer a specific health question.
Pharmaceutical and biotechnology companies known as study sponsors develop protocols for drugs or devices that require testing for safety and to see if a new therapy has a definite benefit. The testing must go through phases. The testing time involved will be several years.
Phase I is the 1st time healthy human subjects have received the study medication and the goal is to determine the safety, side effects and dosages. Phase II involves a larger number of patients to evaluate safety and effectiveness.
Phase III involves a large numbers of patients to confirm safety and effectiveness of a medication or device which is compared to an existing approved therapy or placebo.
Most studies are double-blind trials where neither medical staff nor the patient know which treatment the patient is receiving. To everyone concerned it all looks the same to prevent bias. Patients are randomly assigned to a treatment group such as:
1) A study medication or device which may be investigational
2) A placebo (inactive substance)
3) An existing approved therapy
Part of the patients that are in the study may receive the investigational drug or device while the rest of the patients receive a placebo or another approved therapy.
Patients who volunteer are under close supervision from physicians and research nurses as directed by the protocol. Any changes to health even as seemingly unimportant as worsening of preexisting sinus allergies are reported. For this reason it is extremely important to be very thorough with the Research team about any health issues you are having.
The Sponsors of the studies are legally required to select physicians known as Investigators who are qualified to conduct the trials.
The clinical testing of a product (medication or device) is a step-by-step process that is very closely monitored. All clinical trials are reviewed by the U.S. government's Food and Drug Administration (FDA) and by Institutional Review Boards (IRBs).
IRBs are independent committees made up of professional and lay people whose job is to make sure a study is ethical, that your rights are fully protected and that you are not exposed to any unnecessary risks.
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Your medical chart will be screened by the physician or research nurse to see if you meet certain qualifications or criteria for being in the trial. Your confidentiality is protected by our HIPPA Practices. If you meet criteria, the physician and/or research nurse will call or arrange to see you at an office visit to discuss your potential voluntary participation.
If you decide to enroll in a research trial, you will receive study related procedures such as a physical examination. Your study physician or research nurse will again review your medical history as well. Additionally, you may undergo testing, such as lab work or an echocardiogram as directed by the protocol.
Study procedures are at no cost to the participant unless they are considered standard of care. Standard of care refers to a test or visit that you would have had even if you were not in the study. Some studies require one visit. Other studies may last 1-5 years. The length of a particular study is discussed with you before you agree to participate.
The KentuckyOne Health Cardiology Associates and research nurses who conduct our clinical trials are committed to providing you with quality patient care and medical attention. Patient Safety is our first priority. You should feel free to discuss your medical treatment with your physician or research nurse at any time during the course of your trial. A detailed description of a specific clinical trial and what's expected will be outlined in the Informed Consent form.
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Informed consent is an ongoing process of learning the facts of a study. The most important document for someone, who is considering enrolling in a clinical trial, is the Informed Consent form. The Informed Consent form contains the information you need to know about the trial-how it will be conducted and what your participation in that trial will mean. The informed Consent form is available for you to take home before agreeing to participate, however ample time is provided at your 1st study visit to read, understand and discuss what is in the form.
During the initial visit, the research nurse will go over your medical history to decide if you qualify to participate. If you qualify and wish to enroll in the study now is the time to ask questions. If you have any questions at all, do not hesitate to ask. The nurse or physician will answer them honestly and openly.
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The study participant will have scheduled office visits to collect data for the research trial. At these visits several things may happen depending on what data must be collected. Examples are vital signs, EKG, and lab work. Other testing may be required also. All testing is discussed prior to your enrollment in the study.
Your Study Doctor will review your study related data (vital signs, lab work etc.) monitoring for any safety issues. Any significant findings are quickly reported to the IRB and the Sponsor. Any new information which is learned during a study is also reported back to study participants as directed by the Sponsor and IRB through the Informed Consent process.
You are encouraged to call your research nurse with any questions or concerns during the study.
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After a study is complete, you may want to continue using a drug that has worked well for you. Will you be able to? In some cases, the FDA has already approved the drug you are given in a trial, but the drug is being tested for a different use or on a different dosage schedule. In that case, your doctor may be able to continue to prescribe the drug for you after the trial. On some occasions the patient will stop receiving the investigational treatment. In this case, a patient may have to wait for the drug to become available to the public.
After a study is complete, all of the information is collected and analyzed. This information determines whether a study drug or device is working, whether it is safe and whether it has any serious side effects. FDA medical advisors and specialists closely review this data before approving any new drug or device.
Even after a drug or device is approved, pharmaceutical and device companies will continue to conduct studies that compare the new product, in terms of it's safety, effectiveness and cost, to others that are already on the market, as well as it's impact on the quality of life of the patient.
Every volunteer in a clinical trial is extremely valuable and important. Without volunteers, there would be no new drugs or devices to fight diseases and ailments. By participating in a clinical trial, you are helping yourself and others like you to live longer and healthier lives now and far into the future.
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KentuckyOne Health Cardiology Associates conducts research in the following areas:
Coronary Artery Disease
Heart Failure both systolic and diastolic
Arrhythmia including atrial fibrillation
Anticoagulation (Alternatives to Coumadin)
If you would like more information about our clinical research trials or if you think you might like to participate, please ask your cardiologist.
You may also call our Research Department at 502.779-4900 to speak with a Research Nurse.
Physician Investigator: Gary Fuchs, M. D.
Description: This study is for patients who have atrial fibrillation and are on Coumadin or Warfarin. For many years, pharmaceutical companies have attempted to find an alternative drug to coumadin, that is safer and entails much less follow-up. This study is designed to test a new product that may meet these goals.
Status: Planned enrollment to begin January 2006
Physician Investigator: Matthew Bessen, M. D.
Description: This study is to determine if a type of medication approved for hypertension is beneficial for patients that have a particular type of heart failure known as diastolic failure. A patient with diastolic failure usually has an ejection fraction (EF) over 45%, but still has symptoms of heart failure.
Status: Enrollment closed. Patients are in follow-up.
KentuckyOne Health Cardiology Associates
225 Abraham Flexner Way, Ste. 305
Louisville, KY 40202