One of the common ways patients may access emerging therapies and advanced technology is through clinical research. The Cardiovascular Research Institute (CRI) at THE HEART HOSPITAL Baylor Plano, the Baylor Research Institute, and the Baylor Institute for Health Care Research and Improvement are led by staff and physicians deeply committed to development and implementation of cardiovascular clinical research, contributing to the advancement of the science, teaching new concepts and techniques, and benefiting the community by delivering improved cardiovascular medical care through new, innovative therapies.
With more than 30 investigators participating in important national and international clinical trials, THE HEART HOSPITAL Baylor Plano embraces every opportunity to provide our patients with advanced drug and treatment therapies. Just a few of the important, ongoing trials are listed below and in the more expanded list accessed in the listing at right in the box labeled "Clinical Research."
The ultimate goal of our research efforts is to offer a variety of clinical trials broad enough to afford every patient the opportunity to access today's medical breakthroughs even as they occur.
The IMPROVE Trial
William Brinkman, M.D., Principal Investigator
The primary aim of this data collection is a three-way comparison of the Maquet Minimal Extra-Corporeal Circulation (M.E.C.C.) System, the conventional heart-lung machine and off-pump surgery in the setting of coronary artery bypass grafting. We are offering a less invasive cardiopulmonary bypass option to our patients. Additionally, we will be using genomic mapping to evaluate our patients, which will offer the possibility of identifying numerous genetic markers in the blood that may help us better understand changes during open heart surgery.
The OPTION Trial
David O. Moore, M.D., and Lonnie Ginn, P.A., Principal Investigators
The OPTION study (Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques) is an investigator-initiated trial designed to evaluate the equivalence of minimally invasive Endoscopic Vessel Harvesting (EVH) in Coronary Artery Bypass Graft surgery (CABG) compared with historical data for open vein harvesting. The study standardizes a number of important factors to optimize the procedure and to improve outcomes.
The Everest II/Realism Trial
Paul Grayburn, M.D., Principal Investigator
Mitral regurgitation (MR) affects millions of people worldwide and is the most common type of heart valve insufficiency in the United States and Europe. The vast majority of patients with significant MR are untreated, which leaves their hearts affected by the chronic volume overload caused by MR, requiring the heart to work harder, and ultimately leading to heart failure. THE HEART HOSPITAL recently joined Baylor Jack and Jane Hamilton Heart and Vascular Hospital in conducting the REALISM (Real World ExpAnded MuLtIcenter Study of the MitraClip® System) study. Dr. Michael Mack oversees the trial for THE HEART HOSPITAL. The REALISM study is a continued access registry in follow-up to EVEREST II, the only randomized trial comparing a
percutaneous mitral repair device to mitral valve surgery, which successfully completed enrollment in 2008.
The EXPECT Trial
J. Brian DeVille, M.D., Principal Investigator
In this investigator-initiated study supported by Medtronic, specific postural movements will be observed in patients undergoing left ventricular lead implantation. Left ventricular (LV) lead
capture thresholds will be measured in an effort to gain valuable information concerning the active fixation 4195 LV lead, as well as passive fixation LV leads.
The CABANA Trial
J. Brian DeVille, M.D., Principal Investigator
This trial is sponsored by the NIH with administration from Dr. Packer, Mayo Clinic, Rochester. Patients with atrial fibrillation are randomly assigned to receive either drug therapy (rhythm or rate control) or a catheter ablation procedure in an effort to treat atrial fibrillation.
The CHOICE Trial
Bruce Bowers, M.D., Principal Investigator
This registry was designed to evaluate outcomes of carotid stent patients determined to be high-risk for carotid endarterectomy.
The THRIVE Trial
Dennis Gable, M.D., Principal Investigator
Sponsored by Medtronic, the purpose of this study is to evaluate the long-term safety and effectiveness of the Talent thoracic Stent Graft System. Thoracic stents are used to treat aneurysms (weaknesses) in the section of the aorta that lies within the chest.
The VEST Trial
Hafiza Khan, M.D., Local Principal Investigator, Jay Franklin, M.D.,
Principal Investigator, Baylor Hamilton Heart and Vascular Hospital
VEST is a randomized, controlled trial to determine whether a wearable defibrillator vest (LifeVest, ZOLL Lifecor, Pittsburgh, PA) reduces sudden death mortality in the first 90 days following a myocardial infarction. PREDICTS is an observational cohort study, starting after VEST follow-up is complete, in which a battery of risk stratification tests will be performed and biological samples collected on each study participant for an estimated mean of five years after their MI. The aim of PREDICTS is to develop and validate a multivariable risk stratification tool that predicts the occurrence of spontaneous "shockable" ventricular arrhythmias during the five years after MI, and efficiently identifies very high risk participants in whom an implantable cardioverter-defibrillator (ICD) would be most cost-effective, as well as very low-risk participants in whom it is not needed.
The VIRGO Trial
Deepika Gopal, M.D., Principal Investigator
NIH-sponsored trial to investigate the excess risk in young women
that have experienced an acute myocardial infarction (heart attack) and to identify key demographic, clinical, metabolic,psychosocial, health care delivery and biological factors that may determine prognosis.