Clinical Trials at St. Francis Hospital
St. Francis Hospital has participated in over 220 research trials and been a part of many of the leading edge cardiac interventional studies for the treatment of coronary artery disease, carotid stenosis, and the treatment of cardiac arrhythmias. St. Francis Hospital introduced the Carotid Interventional Program in 1996 and was the only hospital on Long Island to perform carotid stenting procedures. St. Francis has participated in many of the carotid stent trials (CREST, SAPPHIRE WW, BEACH) and continues to participate in post-marketing approval studies, CAPTURE 2, and CHOICE. Recently enrollment has begun for the ACT 1 study, which will enroll subjects with asymptomatic, low risk cartoid stenosis.
Drug eluting stents for the treatment of coronary artery disease were part of the clinical trials conducted at St. Francis Hospital. Both Boston Scientific and Cordis’ drug eluting stents trials were represented at St. Francis Hospital in the TAXUS Trial series and the SISR Trial. Both studies have completed enrollment and are in the follow-up period.
The St. Francis Heart Study was a four-year, randomized, double blind, placebo- controlled study that screened approximately 5,500 participants. Of those, 1,005 of them were found to have a coronary calcium score at or above the 80th percentile for age and gender. This study sought to determine whether lipid-lowering therapy and antioxidants retard the progression of coronary calcification and prevent atherosclerotic cardiovascular disease events.
A Natural History study component was part of the Heart Study. Approximately 4,900 patients were followed for four years. Its purpose was to determine the prognostic accuracy of EBCT scans and its relationship to standard coronary disease risk factors.
The study resulted in two articles that were published in the Journal of the American College of Cardiology in July of 2005. The first paper, “Coronary Calcification, Coronary Disease Risk Factors, C-reactive Protein and Atherosclerotic Cardiovascular Disease Events,” concluded that the CT coronary calcium score predicts CAD events independent of other standard risk factors, as well as CRP, and redefined the Framingham risk stratification of low, intermediate and high risk.
The second paper, “Treatment of Asymptomatic Adults with Elevated Coronary Calcium Scores with Atorvastatin, Vitamin C and Vitamin E,” concluded that using a lipid-lowering agent did not affect the progression of coronary calcification. It may have reduced the number of Atherosclerotic CAD, especially in patients with higher scores, but the effects did not achieve statistical significance.
