Research

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First Coast Cardiovascular Institute, PA (FCCI) has been participating in clinical trials for many years through an independent research center. Starting April 2007 we began our Research Program here at FCCI, naming Dr. Majdi Ashchi as the Medical Director. Taking the lead as Research Manager/Coordinator is Mary Hudson, RN, CCRN, CCRC. Mary brings over 29 years of research experience with 18 years at the University of Florida, 8 years at the Jacksonville Center for Clinical Research and 3 years at The Heart Center, PC in Huntsville, Alabama. All of our physicians have been and are involved in research and are committed to the best of care in a compassionate but comprehensive approach.

FCCI is committed to offering our patients the latest developments in Cardiovascular Disease treatments and therapies. Our current area of interest lie in Carotid, Coronary and Peripheral (kidneys, abdomen and legs), Athrectomy and Stenting using new drugs and/or devices; Atrial Fibrillation with a new novel drug to replace Coumadin (blood thinning) treatment; and Congestive Heart Failure, hoping to find a new therapy to better manage this chronic, progressive disease.

For more information regarding clinical trials or to contact the Research Manager, follow the links below:

What is a clinical (research) trial?

This is a study in which participants (volunteers) evaluate a new therapy (drug or device) for a specific disease or illness to see if there are promising effects that may help patients with this condition in the future. There are 4 phases of research. Phase I is the earliest phase of research and involves a treatment that has limited exposure in humans and generally involves a low number of participants and a very low dose of study treatment to ascertain a patients initial response and if there are any untoward effects. Phase II involves a therapy aimed at treating a specific disease/illness to see if the study treatment can improve or have a positive effect on the specific disease/illness with tolerable untoward effects and usually occurs over short periods of time. Phase III involves large numbers of patients with a specific disease/illness to fine tune the dose of therapy best used to achieve the most beneficial effect with the least amount of tolerable untoward effects and to test long term use. Phase IV involves a treatment that has been approved and marketed and is now being tested to see further long term effects, using different doses than currently approved or for a different disease/illness that it is currently approved for.

What is informed consent?

Informed consent means that you as a participant have been given all the available information, in language that you understand, to make an informed decision without any pressure from any outside force, that your participation is voluntary (by your choice only) and that you have had all of your questions answered prior to your signing the consent form and participating in the clinical trial. After you sign the informed consent you will be given a copy for your records and the original will remain with your research records. If you are in the hospital, a copy will be placed on your permanent hospital record.

Which F.C.C.I. offices are currently involved in research?

The main office on University Blvd. will always be where FCCI Research is housed. We currently have studies enrolling patients at the main office, Memorial Hospital and the Flemming Island Office. We hope to include all hospitals and offices in the future as the research area grows.

Who can participate in clinical trials?

Only patients with a sound mind can participate in a clinical trial unless they have a legal representative that can legally sign for them. Each trial is different and has a very specific list of inclusion and exclusion criteria that must be met prior to enrollment. This means that even if a patient is eager to participate, they may not meet all of the study specific criteria in order to be enrolled. This is not personal. We have strict guidelines set by the FDA (Food & Drug Administration) that must be followed to the letter. This is for both the safety of the patient and the integrity of the trial. You can not be enrolled in a trial against your wishes, even if your legal guardian wants you to. If you do not comply with all of the guidelines set forth by the trial you can be removed from a trial without your consent. It is very important to adhere to every aspect of the trial, including drug compliance (both study treatment and all other prescribed treatment) in order to effectively evaluate the relationship of the study treatment to the disease/illness and how it may interact with your other prescribed treatment. We want to be sure when new therapies become available that they were approved on good clean data received from investigators that did a good job adhering to all of the government and federal regulations.

Questions to ask your doctor.

If you are thinking about taking part in a clinical trial, find out as much as possible about the study and find out how your primary care doctor feels about your participation. Have your primary care doctor call the research physician to discuss your participation and to make sure that he has a good understanding of what you may be participating in. The primary care doctor is an integral part of your health care and should be aware of all treatments that you are on or considering. Their input may be invaluable in helping you and the research physician decide if this is the best option for you.

How can I find out more about clinical trials in general, what trials are currently available at F.C.C.I, and/or whether I qualify for a current trial:

mhudson@firstcoastcardio.com

PHONE: (904) 398-4229

FAX: (904) 493-2222

WRITE: First Coast Cardiovascular Institute, PA
Department of Research/ Mary Hudson
3900 University Blvd. South
Jacksonville, Florida 32216