Orlando Heart Center | Where Every Beat Counts...

The Orlando Cardiovascular Research Institute conducts clinical trials according to Good Clinical Practice (GCP) Guidelines issued by the Food and Drug Administration (FDA) and the Code of Federal Regulations. We participate in multiple Phase II to Phase IV pharmaceutical and device trials, on both an inpatient and outpatient basis. Many of our physicians have attended Investigator GCP Training Seminars and our Study Coordinators are Certified Clinical Research Coordinators. Specific areas of interest include coronary artery disease, electrophysiology, interventional cardiology, nuclear medicine, congestive heart failure, and myocardial infarctions.

Medical Director	Robert P. Dalton MD
Research Manager	Sally Hewit, RN CCRC
Research Coordinators	Kara Work, RN Stephanie Garber, RN
Research Assistant	Theresa Jain

SMART AV - Boston Scientific - A randomized study that will investigate the effects of optimizing AV delay in heart failure patients receiving CRT-D therapy. Patients will be randomized in a 1:1:1 ratio with one group to receive CRT-D device with the AV delay set as fixed nominal, one group set with SmartDelay, or one group determined by echocardiography. All patients will be followed at enrollment, implant, post-implant, 3 and 6 months post-implant.

CHOICE Study – Abbott Vascular – Carotid Artery Stent study

Resolute II Coronary DES Trial – Medtronic Vascular – Non-randomized, unblinded, post-market drug eluting stent trial – 3 different arms with use of 2.5 ml – 3.5 ml stent, 4.0 ml diameter stents, and some patients will be in IVUS arm. FU at 30days and 9 mos, with FU angio at 8 months for IVUS and large vessel arms, and contact telephone visit at 6 & 12 mos, then annually for 5 years.

APPRAISE-2 Study – BMS/PPD – Study to evaluate safety and efficacy of apixaban vs. placebo in subjects with recent Acute Coronary Syndrome and at least 2 additional risk factors for recurrent ischemic events, to determine if apixaban is superior to placebo in preventing CV death, MI, or stroke. Patients will be followed for a minimum of 3 months and a maximum of 3 years.

ST Segment Detection Study (ST Detect) – Medtronic Inc. - Using a Virtuoso ICD, the study will evaluate whether naturally occurring spontaneous coronary events and exercise –induced cardiac ischemia give rise to detectable changes on intra-cardiac electrogram signals. This study will support the development of an Myocardial Infarction alerting system for ICD patients to reduce time between the onset of symptoms to treatment. Patients will have the device implanted, be seen in the office one week later, will have an exercise stress test with nuclear imaging at one month, and visits again at 3 and 6 months. They will be invited to continue to be monitored in the study with the ST Detection Algorithm on until study closure

Drugs to Help Smokers and Block Heart Attacks Show Promise /font>

By ANDREW POLLACK
Published: September 28, 2004, Tuesday

Two experimental drugs developed by biotechnology companies -- one to prevent heart attacks and the other to help people quit smoking -- have shown promising preliminary results, executives said.

OOne company, AtheroGenics, said yesterday that its drug for atherosclerosis had significantly reduced the volume of plaque that can clog arteries. The results, in a midstage clinical trial, sent the company's stock soaring in after-hours trading.

The other company, Nabi Biopharmaceuticals, is expected to announce today that its vaccine against nicotine helped people quit smoking in a small clinical trial. /span>

The results of the AtheroGenics trial had been eagerly awaited because removing fatty plaque from the arteries is considered a new goal for cardiovascular drug therapy. Even the statins, the widely used anticholesterol drugs, do little if anything to reduce plaque.

AtheroGenics said its drug, AGI-1067, reduced plaque volume about 3 percent to 4 percent after a year, as measured with ultrasound. The reduction was statistically significant compared with the patients' starting levels, but not compared with the lesser reductions in patients who got a placebo.

Doctors in the trial cautioned that the preliminary results covered only 133 of about 260 patients, but nevertheless were promising.

''We want to see the final data but at the same time, I'm encouraged,'' Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, said on a company-sponsored conference call with analysts. ''It's a substantial change.''

Dr. Nissen said that while it could be misleading to compare the results of different trials, the reduction in plaque achieved by AGI-1067 was roughly equivalent to that recorded in a 47-patient trial last year using a drug developed by Esperion Therapeutics. In December, shortly after the results of Esperion's trial were announced, Pfizer agreed to pay $1.3 billion to acquire the company.

Speculation that AtheroGenics might also be acquired -- or at least will sell the rights to AGI-1067 for a large sum -- helped fuel the rise in the company's stock. The stock closed down 43 cents at $23.16 in regular trading but soared as much as 80 percent in after-hours trading.

AGI-1067, which fights the inflammation involved in heart disease, is in some sense more attractive than Esperion's drug because it is taken as a pill rather than given by intravenous infusion. AtheroGenics, based in Alpharetta, Ga., is already in a final-stage trial to determine if the drug actually does prevent heart attacks. If so, it hopes to apply by the end of next year for approval from the Food and Drug Administration.

As for Nabi's nicotine vaccine, 33 percent of those who got the highest dose quit smoking for at least 30 consecutive days compared to 9 percent who got a placebo, Dr. Henrik S. Rasmussen, Nabi's senior vice president for clinical, medical and regulatory affairs, said in an interview. Still, the trial was small, with only 68 patients, and it could not be ruled out that the difference between the vaccine and the placebo resulted from chance.

Two investigators in the trial, Dr. Stephen I. Rennard of the University of Nebraska and Dr. Dorothy Hatsukami of the University of Minnesota, called the results encouraging.

Smokers find it hard to quit because the nicotine binds to receptors in the brain and gives them a positive feeling, Dr. Rasmussen said.

The vaccine, which was given by four injections over six months in the trial, consists of nicotine connected to a detoxified bacterial protein, which, when injected, causes the body to form antibodies against nicotine. (Just injecting nicotine by itself would not elicit the antibodies.) After that, if a person smokes, the antibodies would bind to the nicotine and prevent it from reaching the brain.

''We're basically taking away the positive enforcement, which is the main reason people can't stop smoking,'' Dr. Rasmussen said.

Nabi, based in Boca Raton, Fla., will do more studies to determine the best dose and hopes to begin final-stage trials by the end of next year, Dr. Rasmussen said.

Xenova, a company based in Britain, and Cytos, based in Switzerland, are also working on nicotine vaccines, while Pfizer and Sanofi-Aventis are testing drugs that work by other means. The therapies already approved to help people quit smoking are GlaxoSmithKline's drug Zyban, and a variety of patches, gums and other products that contain nicotine, Dr. Rennard said.

Published: 09 - 28 - 2004 , Late Edition - Final , Section C , Column 3 , Page 3

Device helps weak hearts pump better -- so people can live better

By Robyn Suriano: Sentinel Staff Writer

Just walking across the room was hard for Ella Kindergan last year, when a weak heart kept her from doing almost everything. But a few months ago, she trekked around Niagara Falls on vacation while an experimental device in her chest pushed her heart to beat more strongly.

The device belongs to a new class of implants for congestive heart failure, a potentially crippling condition that affects millions of people worldwide. Many stop responding to medication, grow increasingly weak and end up house-bound. Doctors say a portion of those patients -- up to about 650,000 Americans -- are candidates for the devices...
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Current Clinical Trials

Saturn Study – AstraZeneca – Phase IIIb study comparing effects of tx with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by IVUS in pts. with CAD.

Current/Promote Automaticity IDE Study – St. Jude Medical – A prospective, non-randomized multi-center trial that will be conducted to assess the safety and efficacy of the Promote CRT-D models and Current RF ICD models or other St. Jude Medical ICD/CRT-D system with similar functionality.

ARYx 505 – ARYx Therapeutics – A fib study which is follow-up to the current study which compares Warfarin with study drug. Treatment period is 12 months.

Freedom Study – SJM - Evaluate the benefits of frequent AV/PV and V-V delay optimization using Quick Opt in patients with CRT-D devices.

PREDICT Study – CardioDX –The purpose of this study is to identify a gene expression signature in peripheral blood cells that closely correlates with the presence of clinically significant coronary artery disease as determined by invasive X-ray coronary angiography and/or multi-slice computed tomography coronary angiograph.

Triumph I Study – Lung Rx – Efficacy and tolerability of inhaled treprostinil sodium in patients with severe pulmonary arterial hypertension.

The National Institutes of Health provides a thorough explanation of how clinical trials are conducted and classified. Details for research participants are discussed at http://clinicaltrials.gov/

Research Highlights

Drugs to Help Smokers and Block Heart Attacks Show Promise /font>