Health Screenings Every Woman Needs

What is a

CLINICAL TRIAL?

You may have heard the term ‘clinical trial’ without really knowing what it means. Well, simply put clinical trials are studies performed on individuals, with the aim of evaluating a new medical, surgical, or behavioral intervention. They are fundamental for helping us determine if an intervention being studied actually works and if it is safe or not. If you think about it, every medicine or treatment option we currently have available, has been through long and stringent clinical trials before getting FDA approval and thus becoming available to all. Why would you want to participate?

People participate in clinical trials for a variety of reasons. Some of the common reasons for people to join are hopes of obtaining a better treatment option, assisting others with the same condition, and advancing science and medicine.

Time commitment involved?

New and innovative treatments go through multiple phases of Clinical trials before they become available to the public, below caption is taken verbatim from clinicaltrials.gov and we feel gives a very good description of the process and its multiple phases: Phase 3: A phase of research to describe clinical trials that gather more information about a drug’s safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Phase 4: A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug’s safety, efficacy, or optimal use.

New Devices (like stents or valves or pace-makers, etc.) go through a different approach and less “phases” in their development until reaching the approval of the FDA.

Phase 1: A phase of research to describe clinical trials that focus on the safety 4 PHASES of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug’s most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2: A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug’s effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

The Research Department at First Coast Cardiovascular Institute

First Coast Cardiovascular Institute’s (FCCI) Research Department dates back to 2007 – when it was founded with top standards. Our research department has gone on to achieve many milestones and has been involved in several pre-market device and therapeutic trials that have been FDA approved and are now on the market.

FCCI’s Research Department is actively involved in numerous clinical trials including medical devices and therapeutic treatment. We are currently looking for patients with: • congestive heart failure • chronic kidney disease • peripheral vascular disease • non-healing foot wounds • Other heart related conditions

If you are interested in participating, please speak to your physician at your next visit or contact FCCI at 904.493.3333.

Are we bound by our DNA?

While popular belief may lead most to believe that genetic predisposition and genetic risks are unavoidable – the case does not seem to stick when it comes to coronary heart disease or heart attack, ultimately showing us that our DNA is not really our destiny. A recent study published by the American Heart Association has taken roughly 11,000 individuals under their examination for an extensive period of time. The study took into account seven cardiovascular health factors such as smoking status, body weight, total cholesterol, physical activity, blood sugar, and diet. These categories were then ranked subsequently into ideal, intermediate, and poor. The study yielded that ultimately – we are not bound by our DNA and that our DNA is not really our destiny. Lifestyle modifications can in fact play a bigger role than our genes in determining our risk for heart disease. What the study concludes is that adherence to the Life’s Simple 7 recommendations was directly associated with lower lifetime risk of coronary heart disease for all individuals – especially those with high genetic susceptibility. The take home message is that positive lifestyle factors have a great impact on decreasing the risk of coronary events. To such an extent that following favorable lifestyle methods can decrease risk of coronary events by 50 percent, even among individuals with high genetic risk. The conclusions from the studies show unequivocally that lifestyle trumps genetics and by an abundance of 9 years of survival. Someone with the worst genetics yet the best lifestyle will outlive another with best genes yet worse lifestyle by 9 years. If you are thinking of ways to optimize your heart’s health, referring to the American Heart Association Life’s Simple 7 recommendations is a great place to start.