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Advanced Cardiac Specialists

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STENT/CORONARY INTERVENTION TRIALS

The ACS Catheterization Laboratory runs a busy, top quality Coronary Intervention program. This makes it an ideal site for select, cutting-edge research trials in the setting of Coronary Heart Disease, Unstable Coronary Syndromes, including Acute Myocardial Infarction (‘heart attack"), and Stenting of Coronary Arteries (a stent is a metallic device introduced into an artery to keep it open and decrease the chances of re-closure after an angioplasty).

List Of Hospital-Based Trials Currently Enrolling Patients

CADILLAC:

ACS treats all eligible patients with an acute or evolving heart attack with primary or direct angioplasty (mechanically opening up the occluded coronary artery by angioplasty or stent). This trial involves a randomized comparison of the new Rx Multi-Link™ Coronary Stent System versus direct balloon angioplasty in the treatment of patients presenting with Acute Myocardial Infarction. Patients are followed up in the office at two weeks and four weeks after the procedure. Some patients return at six months for a repeat diagnostic coronary angiogram. Sponsor: Advanced Cardiovascular Systems, Inc. / Lilly Research Laboratories, 1998 to present.

ADMIRE:

In acute myocardial infarction, cell death is due to both prolonged ischemia (from a blocked artery) and reperfusion injury (on re-establishing flow to the myocardium). AMP579 is an adenosine agonist that attempts to combat reperfusion injury. The objective of this trial is to increase salvage of jeopardized heart muscle, following direct angioplasty in acute infarction. Since AMP579 is an A1 and A2 adenosine receptor agonist, it has a superior cardioprotective profile over currently available selective A1 receptor agonists. In this randomized, placebo-controlled trial, the drug is administered intravenously over six hours at presentation to the cath lab/Coronary Care Unit. Patients are followed up at four -to-six weeks and at six months, to assess the volume of myocardial salvage and the improvement in global heart contractility. Sponsor: Rhone-Poulenc Rorer / Mayo Physicians (M-PACT), 1997 to present.

SYMPHONY:

This is a multicenter, international randomized, double-blind trial to evaluate the safety and efficacy of a oral Sibrafiban in the prevention of secondary vascular events in patients after an acute coronary syndrome. The initial event in an acute coronary syndrome is the aggregation of platelets (a specialized line of blood cells); the final event is usually the formation of an intracoronary thrombus, which occludes coronary blood flow. Sibrafiban is a new and advanced potent and selective antagonist of a specific platelet surface receptor, that inhibits platelet aggregation. The objective of the trial is to   prevent/minimize repeat coronary vascular events in these patients. It is administered orally for a period of 90 days, and patients are followed up with regular office visits at two weeks, one, three, six, and  twelve months. Sponsor: G.D. Searle & Co., 1998 to present.

WINS:

This trial evaluates a new stent in the treatment of graft closure. It enrolls post-coronary bypass surgery patients presenting with stenosis (closure) or restenosis (re-closure) in one or more coronary grafts. Eligible patients receive the Schneider Wall Stent and are followed regularly in the office for about one year. Patients also fill out a QOL (quality of life) questionnaire at six months and then every year. Sponsor: Schneider (USA) Inc., 1997 to present.

GUARDIAN:

This trial evaluates a new and adjuvant approach to prevent myocardial cell necrosis in severe myocardial ischemia, by inhibiting (sodium -hydrogen) ionic exchange at the plasma membrane level. The drug Cariporide is used to prevent actual cell destruction, rather than just limiting the size of myocardial infarction (cell death). It involves a randomized, double-blind, placebo-controlled trial where the drug is administered as an intravenous infusion thrice daily, for two to seven days. Patients are followed up for six months following the procedure, for all-cause mortality and repeat infarction related to the disease process or to an interventional procedure. Sponsor: Hoechst Marion Roussel / Quintiles, 1997 to present.

AIR PAMI:

This trial compares the effectiveness of thrombolytic therapy ("clot busters") versus direct infarct intervention (primary angioplasty) as the first line of treatment in high-risk patients presenting with acute myocardial infarction. Collaboration with: William Beaumont Hospital, University of Michigan, 1996 to present.

ADVANCED CARDIAC SPECIALISTS

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