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The Clinical Research Experience at Medical Center Cardiologists
The Medical Center Cardiologists Research Foundation was founded in 1998 to serve Louisville and surrounding areas in both Kentucky and Indiana.
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 Medical Center Cardiologists.
Clinical research trials at Medical Center Cardiologists 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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What
is a clinical research trial?
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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What can I expect if I decide to participate in a research trial?
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 Medical Center Cardiologists 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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What
is Informed Consent?
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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What
happens during the clinical trial?
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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What happens after the clinical trial ends?
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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What types of studies are done at Medical Center Cardiologists?
Medical Center Cardiologists conducts research in the following areas:
Coronary
Artery Disease
Heart Failure both systolic and diastolic
Arrhythmia including atrial fibrillation
Cholesterol
Pacemakers
Implantable Defibrillators
Biventricular Pacemakers
Stents
Anticoagulation (Alternatives to Coumadin)
Cardiac Markers
Cardiovascular Medications
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 779-4900 to speak with a Research Nurse or send a e-mail message to: research@kycardiology.com
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Current Research Trials that are in progress at Medical Center Cardiologists
ATHENA
Physician Investigator: Michael Springer, M. D.
Description: This study is for patients that have a history of both normal rhythm and atrial fibrillation. The primary purpose is to determine if the investigational medication can reduce cardiovascular hospitalizations.
Status: Currently enrolling
APNEA-CHF
Physician Investigator: Michael Springer, M. D.
Description:
This study is for patients that have severe heart failure and qualify
for a Continuous Resynchronization Device (CRT). These patients
will also be tested to see if they have sleep apnea. It is known that
50% of all heart failure patients have sleep apnea. The question is
to determine if the Continuous Resynchronization Therapy will
make a positive health impact on a heart failure patient with sleep apnea.
Status: Currently enrolling at Jewish Hospital and Baptist Hospital East
RELY
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
SPIRIT III
Physician Investigator: Daniel McMartin, M. D.
Description:
This study is for patients who present for an intervention to a
coronary artery, during a cardiac catheterization. This trial entails
using a specific type of coronary stent that may reduce re-stenosis
of the stent.
Status: Currently enrolling at Jewish Hospital
TIMI 38
Physician Investigator: Daniel McMartin, M. D.
Description: This study is for patients that require a balloon angioplasty for a heart attack or heart/chest pain. The study will help to determine if an investigational medication can reduce deaths, future heart attacks and strokes by aiding in keeping blood clots from forming.
Status: Currently enrolling at Jewish Hospital
DECREASE HF
Physician Investigator: Michael Springer, M. D.
Description:
This study is for patients that require implantation of a heart failure
device, called Continuous Resynchronization Therapy (CRT). The
study is attempting to determine the most beneficial and safe
mode of programming the device for individual patients, based on
their needs.
Status: Enrollment completed. Patients are in follow-up.
ReASsure
Physician Investigator: Michael Springer, M.D.
Description: This study is for patients who need a pacemaker. These patients have additional potential risk factors for ventricular arrhythmias but don't qualify for a defibrillator by current standards. These risk factors include diabetes, hypertension, coronary artery disease, prior heart attack, heart failure, obesity, high cholesterol, and family history of sudden cardiac death. Patients receive an investigational pacemaker with rescue shock therapy.
Status: Enrollment complete. Patients are in follow-up.
I PRESERVE
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.
LESS-AF
Physician Investigator: Michael Springer, M. D.
Descriptions:
This study is for patients who are going to receive a pacemaker or
implantable defibrillator (ICD), who do not have a history of atrial fibrillation.
One of the two wires from the device is placed at one of two pre-determined
sites in the heart. The information that the sponsor is seeking is to see
if atrial fibrillation is more common if the wire is placed in one spot
versus the other.
Status:
Enrollment completed. Patients are in follow-up.
  
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Copyright
© 2003 Medical Center Cardiologists, PSC. Last updated May 25,
2004
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