Baptist Cardiac and Vascular Institute : National Institute of Health Clinical Trials 

Baptist Cardiac & Vascular Institute
8900 North Kendall Drive
Miami, Florida 33176
786-596-5990


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 National Institutes of Health Clinical Trials  

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people’s health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases.

Carotid Stenosis
CREST (Carotid Revascularization Endarterectomy Stenting Trial)
The Institute is one of 42 sites in the nation participating in the NIH-sponsored CREST trial of 4,300 subjects, in which carotid stents are being compared to surgery, called endarterectomy. This study is for people who have had a small stroke or a temporary stroke called a transient ischemic attack (TIA). 
 
CREST physicians want to find a better way to prevent strokes in people who have a narrowing in their carotid artery. This research study will compare carotid endarterectomy, a common operation to prevent stroke, to a study procedure, called carotid artery stenting. Patients who agree to participate in the CREST study will receive either carotid endarterectomy or carotid artery stenting to treat the narrowed area in their carotid artery.

Principal Investigator:  Barry Katzen, M.D.
Co-Investigator:  Gerald Zemel, M.D.
Surgeons:  Athanassios Tsoukas, M.D.; Orlando Puente, M.D. 


Diabetes(Type 1 or Type 2) With Cardiac Disease Requiring Intervention FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus:  Optimal Management of Multivessel Disease)

This study is a NIH-sponsored registry of 120 institutions and 2,400 subjects with diabetes mellitus(Type 1 or Type 2) with multivessel coronary artery disease who will be randomized (by chance) to either  Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) surgery. The study will involve research participants in medical centers in the United States, Canada, Europe and South America.

Principal Investigator:  Ramon Quesada, M.D.
Co-Investigators: Marcus St. John, M.D.; Dean Heller, M.D.; Julius Gasso, M.D.; Rajesh Dhairyawan, M.D.
Surgeon: Niberto Moreno, M.D.


Cardiac Disease "Alternative Medicine"
TACT (Trial to Assess Chelation Therapy)

Chelation therapy is a commonly used alternative medicine practice for preventing heart disease. It involves intravenous administration of EDTA combined with high-dose antioxidant vitamin and mineral supplements. Although it is estimated that more than a million patients have received some 20 million infusions, there have been few randomized trials to test the safety or effectiveness of one or more elements of the infusion. The Trial to Assess Chelation Therapy (TACT) is a NIH five-year, randomized (by chance), double-blind, placebo-controlled trial.

The two factors are chelation vs. placebo, and high-dose vitamins vs.placebo vitamins. All participants receive low-dose vitamins. The primary outcome is the incidence of clinical cardiovascular events during the trial period. Other outcomes include quality of life and the relative cost effectiveness of the therapies.  The study will involve 1,950 patients at 150 clinical sites.

Principal Investigator:  Barry Katzen, M.D.
Co-Investigators:  Ramon Quesada, M.D.; Dean Heller, M.D.; Marcus St. John, M.D.

Cardiac/Myocardial Infarction Study
PACE MI (PACEmaker and Beta-Blocker Therapy after Myocardial Infarction)

This study sponsored by the National Institute of Health: National heart, Lung and Blood Institute purpose is to determine if the combination of pacemaker implantation and beta-blocker therapy in patients with bradycardia will be superior to standard therapy, which would not include a beta-blocker. This study involves a Randomization Arm to pacemaker implementation or conventional medical therapy as well as an Observational Arm for those who receive beta-blocker medications.

Principal Investigator: Efrain Gonzalez, M.D.




Baptist Health Articles

09.30.2008 New Treatment to Prevent Strokes
09.30.2008 About Aortic Aneurysms
09.29.2008 Ricardo C. Cury, M.D., Named Medical Director of Cardiac MR and CT at Baptist Hospital and Baptist Cardiac & Vascular Institute
09.29.2008 Italo Linfante, M.D., Named Medical Director of Interventional Neuroradiology for Baptist Hospital Neuroscience Center and Baptist Cardiac & Vascular
11.06.2007 Barry T. Katzen, M.D., honored with Career Achievement Award