HVI Research Institute

At Saint Joseph's Heart and Vascular Institute, we understand that research is integral to discovering more effective and innovative ways to screen for, diagnose, prevent, and treat cardiovascular disease. Our commitment to research, performed through the Saint Joseph's Research Institute (SJRI) and the Saint Joseph's Translational Research Institute (SJTRI), has enabled us to become one of the leading research institutions in the Southeast.

Clinical Research

Clinical research applies translational research to patients and ensures that the results are safe and effective. Ongoing clinical trials at Saint Joseph's Research Institute include:

• Angiogenesis. Saint Joseph's Research Institute is one of only six institutes in the world undertaking these trials, which focus on promoting blood vessel growth in patients whose hearts or limbs lack adequate blood supply as a result of vascular disease.
• Coronary intervention studies. These studies examine treatments for narrowed arteries including medical therapies, radiation, and the use of drug-eluting stents. Saint Joseph's Research Institute was extensively involved in the initial research using drug-eluting stents and, as a result, the devices were available at Saint Joseph's Hospital long before the stents were introduced to other healthcare providers.
• Cardiothoracic and vascular tissue engineering. These trials are using cell line therapy to grow, repair, or replace damaged heart muscle and valves.

For more information about SJRI, our active clinical trials, and how to participate in a trial, please call (678) 843-6050.

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What is a Clinical Trial?

• A clinical trial is a carefully written plan that involves volunteers such as you.
• It is designed to advance the development of medical therapies for various conditions.
• It also answers important medical questions about those conditions.
• A clinical trial is used to evaluate the effectiveness of a proposed, new therapy.
• Once enrolled in a clinical trial to receive an investigational product, you will be carefully monitored by the investigator and other research professionals.
• Clinical research has led to important discoveries that make our lives better such as new drugs and new devices to treat different medical problems.
• No new therapies would be developed without clinical trials.

Why are clinical trials conducted?

• To determine if a new drug or device is safe and effective for patients to use.
• Existing treatments are often compared to determine which is better.
• Drugs that are already approved are studied to determine different ways to use them and how to use them more effectively.

What can I expect?

Saint Joseph's investigators and research staff are committed to providing you with quality patient care and medical attention. You should feel free to discuss your medical treatment with investigator or the research staff at any time during the course of the clinical trial. As a volunteer you have the right to leave the study at any time for any reason.

It's your decision.

Your choice to participate in a clinical trial is voluntary and an important personal decision. Talk with your physician about possible participation in a clinical trial.

All clinical trials have been independently reviewed by a committee called the Institutional Review Board (IRB). This committee is responsible for making sure your rights are fully protected and that you are not exposed to any unnecessary risks.

We offer you the latest in medical technologies. By offering research to our patients we offer you the latest in medical technologies. Research can also offer you another option if you are not receiving optimal results with current therapy.

Clinical research is an integral part of services offered to patients at Saint Joseph's Hospital of Atlanta. Saint Joseph's Hospital, with its uncompromising quality and dedication to clinical excellence, is bringing state of the art research opportunities to our community through the Saint Joseph's Research Institute (SJRI). SJRI conducts clinical trials in a variety of medical specialties.

Your choice to participate in a clinical trial is voluntary and an important personal decision. It's your decision. Talk with your physician about your interest in participation in a clinical trial.

Without clinical trials, no new medical therapies would be offered. If you are interested in the research available at Saint Joseph's Hospital, please discuss with your physician.

Pre-Clinical Research

Saint Joseph's Translational Research Institute (SJTRI) is one of the nation's leaders in translational research. Transferring the best of science and technology into improved care for patients, SJTRI gathers scientists, industry partners, leading physicians and a network of international experts to develop, test and rapidly deploy new device and drug therapies, as well as diagnostic and biotechnology procedures. This bench-to-bedside methodology ensures patients receive the best treatment protocols, devices and therapies.

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Current Clinical Trials

• Valvular Heart Disease
• Coronary Artery Disease / Myocardial Infarction
• Electrophysiology / Arrhythmia
• Preventative Cardiology
• Carotid Artery Disease
• Heart Failure
• Cardiac Surgery

Valvular Heart Disease

Title: The Medtronic CoreValve^® U.S. Pivotal Trial
Sponsor: Medtronic
Principle Investigator: Louis Heller, MD and Steven Macheers, MD
Sub Investigators: Spencer King, MD, David Langford, MD, William Lieppe, MD, Stephen Frohwein, MD, Jason Reingold, MD
Contact for Referrals: Rita Campbell, RN, CCRC (O) 678-843-6165 or (C) 404-210-1207 or Sonya Mathewson, RN, CCRC (O) 678-843-6092 or (C) 404-274-2368
Purpose: To evaluate the safety and efficacy of Medtronic CoreValve^® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.
Patient Criteria: 1) Aortic valve stenosis with a mean gradient >40 mmHg, jet velocity greater 4.0 m/s or an initial aortic valve area of ?0.8 cm2 (or aortic valve area index ?0.5 cm2/m2) by resting echocardiogram. 2) Subject is symptomatic with NYHA Class II or greater.

Title: Pivotal Study of a Percutaneous Mitral Valve Repair System (EVEREST II)
Sponsor: Evalve, Inc.
Investigator: Louis Heller, MD
Sub Investigators: Douglas Murphy, MD, Spencer King, MD, Stephen Frohwein, MD
Contact for Referrals: Sonya Mathewson, RN, SJHA 678-843-6092 or Rita Campbell, RN, SJHA 678-843-5578
Purpose: To evaluate an investigational, percutaneous (catheter-based) device for mitral regurgitation (MR)
Patient Criteria: Must be 18 years or older and have been diagnosed with moderate to severe or severe mitral regurgitation.

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Coronary Artery Disease / Myocardial Infarction

Title: Evaluation of the Safety and Efficacy of Short-term A-002 Treatment in Subjects with Acute Coronary Syndromes (Vista 16)
Sponsor: Anthera Pharmaceuticals, Inc.
Principle Investigator: Jason Reingold, MD
Sub Investigators: Stephen Frohwein, MD, Nicolas Chronos, MD, Lee Padove, MD, L.Van-Thomas Crisco, MD, Hector Malave, MD, George Chang, Michael Lipsitt, MD, MD, Spencer Palmer, MD, William Lieppe, MD, Anshul Patel, MD, Thomas Guest, MD, Donald Jansen, MD, Steven Eisenberg, MD, Marc Unterman, MD
Contact for Referrals: Ursula Wold, RN, CRC 678-843-6089 (O) 404-889-5839 (C)
Purpose: To evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome.
Patient Criteria: 1) Men and women > 40 years of age
2) A diagnosis of unstable angina, non-ST segment elevation myocardial infarction or ST-segment elevation myocardial infarction.
3) All subjects must have the presence of at least one of the following factors: diabetes mellitus, history of stroke or TIA, PVD, previous CABG, previous MI, previous coronary revascularization or presence of one of the following: waist circumference >102 cm in males, >88 cm in females, triglycerides >150, HDL-C <40 mg/dL in males, <50 mg/dL in females, blood pressure >130/85, plasma glucose >110.

Title: PROMISE - Prospective Imaging Study for Evaluation of Chest Pain
Sponsor: NIH
Principle Investigator: Stephen Frohwein, MD
Sub Investigators: Michael Balk, MD, Gregory Ang, M., Jason Reingold, MD
Contact for Referrals: Cindy Ellis-Bailey, RN, CRC (O) 678-843-6052 (C) 404-831-9480
Purpose: To determine whether the information derived from anatomic imaging strategy (>64 slice CTA) as compared to functional testing strategy (usual care) will provide superior clinical outcomes in patients with symptoms concerning for coronary artery disease.
Patient Criteria: 1) Males ?45 years old; Females >50 years old. 2) Non-emergent diagnostic imaging procedure indicated. 3) Absence of acute coronary syndrome

Title: Pegasus-Timi 54
Sponsor: AstraZeneca
Principle Investigator: Steven Eisenberg, MD
Sub Investigators: George Chang, MD, Thomas Guest, MD, Donald Jansen, MD, William Lieppe, MD, Spencer Palmer, MD, Laura Gonzalez, MD, Anshul Patel, MD
Contact for Referrals: Ursula Wold, RN, CRC (O) 678-843-6059 or (C) 404-889-5839
Purpose: To compare the effect of long-term treatment with ticagrelor vs. placebo on a background of acetyl salicylic acid (ASA) on the event rate of the composite of cardiovascular death, non-fatal infarction (MI), or non-fatal stroke in patients with history of MI and high risk of developing atherothrombotic events.
Patient Criteria: Male and Female patients ?50 years of age with history of MI (1-3 years ago) and at least 1 of the following risk factors: ?65 years, diabetes, a second prior MI, evidence of multivessel coronary disease or chronic non-end stage renal dysfunction.

Title: CHAMPION PHOENIX - A clinical trial comparing cangrelor to clopidogrel standard of care therapy in subjects who require percutaneous coronary intervention.
Sponsor: The Medicines Company
Investigator: Michael Lipsitt, MD
Sub Investigators: Amol Bapat, MD, Marcus Brown, MD, George Chang, MD, L. Van-Thomas Crisco, MD, Sean Delaney, MD, Lance Friedland, MD, Louis Heller, MD, William Lieppe, MD, Spencer Palmer, MD, Edward Proctor, MD, Philip Romm, MD, Marc Unterman, MD
Contact for Referrals: Marianne Bain, RN, CRC (O) 678-843-6074 (C) 404-275-8627 or Cindy Ellis-Bailey, RN, CRC (O) 678-843-6052 (C) 404-831-9480
Purpose: Demonstrate that in patients requiring percutaneous coronary intervention (PCI), cangrelor provides superior efficacy to clopidogrel standard of care, as measured by a composite of all cause mortality, myocardial infarction (MI), ischemia-driven revascularization (IDR) and stent thrombosis.
Patient Criteria: Patients at least 18 years of age with stable angina (SA), non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and ST-segment elevation myocardial infarction (STEMI) who require PCI and have not received a P2Y12 inhibitor with in 7 days prior to randomization.

Title: SOLID TIMI 52 - A clinical Outcomes Study of Darapladib versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
Sponsor: GlaxoSmithKline
Investigator: George Chang, MD
Sub Investigators: Steven Eisenberg, MD, Laura Gonzalez, MD, Thomas Guest, MD, Donald Jansen, MD, William Lieppe, MD, Spencer Palmer, MD, Anshul Patel, MD
Contact for Referrals: Cindy Ellis-Bailey, RN, CRC (O) 678-843-6052 (C) 404-831-9480
Purpose: To evaluate clinical efficacy of long-term treatment with Darapladib Enteric Coated Tablets, 160mg (oral once daily dose) as compared to placebo when added to standard of care in ACS (Acute Coronary Syndrome) patient population on the incidence of first occurrence of the composite of MACE (Major Adverse Cardiovascular Events).
Patient Criteria: 1) Hospitalization for ACS (unstable angina, non-ST elevation MI, or ST segment elevation MI) ?30 days prior to randomization. 2) All subjects must have at least one additional cardiovascular risk factor.

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Electrophysiology / Arrhythmia

Title: SLS Study- System Longevity Study
Sponsor: Medtronic, Inc.
Principle Investigator: David Wilson, MD
Sub Investigators: George Chang, MD, Laura Gonzalez, MD, Mohammad Kooshkabadi, MD, Anshul Patel, MD, Bryan Piedad, MD, Michael Riley, MD, Niraj Sharma, MD
Contact for Referrals: Cindy Barnes, RN, CRC 678-843-6093 (O) 404-275-8369 (C)
Purpose: Evaluate and publish the long-term reliability and performance of Medtronic market-released cardiac therapy products by analyzing product survival probabilities.
Patient Criteria: Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for pacing, sensing or defibrillation application.

Title: Medtronic Post-MI Remodeling Prevention Therapy (PRomPT)
Sponsor: Medtronic, Inc.
Principle Investigator: Niraj Sharma, MD
Sub Investigators: George Chang, MD, Laura Gonzalez, MD, Mohammad Kooshkabadi, MD, Anshul Patel, MD, David Wilson, MD, Marc Unterman, MD, William Lieppe, MD, Thomas Guest, MD, Eugene Edward Proctor, MD, Philip A. Romm, MD, Lance B. Friedland, MD, Marcus L. Brown, MD, Michael Lipsitt, MD, Donald Jansen, MD, Steven Eisenberg, MD
Contact for Referrals: Cindy Barnes, RN, CRC 678-843-6093 (O) 404-275-8369 (C)
Purpose: To demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute MI in patients at highest risk for adverse myocardial remodeling.
Patient Criteria: Subject has experienced an MI within the past 10 days. Subject is at least 18 years old. Subject is willing and able to comply with the protocol, including required follow up visits, and randomization assignment.

Title: Attain Success
Sponsor: Medtronic
Investigator: Niraj Sharma, MD
Sub Investigators: David Wilson, MD, Anshul Patel, MD, Michael Riley, MD, Bryan Piedad, MD, George Chang, MD, Mohammad Kooshkabadi, MD
Contact for Referrals: For More information contact Cindy Barnes, RN, CRC (O) 678-843-6093 (C) 404-275-8369
Purpose: The purpose of this trial is to assess left-heart lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.
Patient Criteria: Subject will be implanted with Medtronic CRT device and Medtronic left-heart lead utilizing (or attempting to utilize) Attain Family of delivery catheters. The implant procedure may include upgrades to CRT from IPG or ICD.

Title: MADIT-RIT - Multicenter Automatic Defibrillator Implantation Trial: Reduce Inappropriate Therapy
Sponsor: Boston Scientific Corporation
Investigator: Niraj Sharma, MD
Sub Investigators: George Chang, MD, Mohammad Kooshkabadi, MD, Anshul Patel, MD, Bryan Piedad, MD, Michael Riley, MD, David Wilson, MD
Contact for Referrals: Renee Gaiter, RN, BSN, CRC (O) 678-843-6084 (C) 404-889-5806
Purpose: The primary objective of the study is to determine if dual-chamber ICD or CRT-D devices with high rate cutoff (MADIT-RIT-B) and/or long delay (MADIT-RIT-C) are associated with fewer patients experiencing inappropriate therapies (ATP or shock) than standard programming (MADIT-RIT-A) during post-implant follow-up of patients with indication for primary prevention device therapy.
Patient Criteria: 1) Primary prevention patient with ischemic or non-ischemic heart disease who meets current guidelines for dual-chamber ICD or CRT-D device therapy. 2) Patient is in sinus rhythm. 3) Patient on stable optimal pharmacologic therapy for the cardiac condition or who has developed a recent ICD indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy. 4) Patient must be >21 years of age.

Title: QuickFlex^® µ Model 1258T Left Heart Pacing Lead Post Approval Study
Sponsor: St. Jude Medical
Investigator: Niraj Sharma, MD
Sub Investigators: George Chang, MD, Mohammad Kooshkabadi, MD, Anshul Patel, MD, David Wilson, MD
Contact for Referrals: Cindy Barnes, RN, CRC (O) 678-843-6093 (C) 404-275-8369
Purpose: The purpose of this study is to evaluate the acute and chronic performance of the QuickFlex^® µ 1258T LV lead in a patient population indicated for implantable cardioverter defibrillator and cardiac resynchronization therapy.
Patient Criteria: Have an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system.

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Preventative Cardiology

Title: Family Heart Disease Demonstration Project
Sponsor: H. Robert Superko, MD
Investigator: Stephen Frohwein, MD
Sub Investigators: Basil Margolis, MD, Jeffrey Marshall, MD
Contact for Referrals: Cathy Skrifvars, RN, BSN (O) 678-843-6152 or (C) 404-290-5849
Purpose: To reveal the potential clinical utility of identifying high heart disease risk family members of patients with established coronary heart disease (CHD).
Patient Criteria: 1) Established CHD with onset prior to the age of 60 years in men and 70 years in women. 2) Two or more first degree adult relatives willing to participate. 3) Participating first degree relatives >25 years of age for men and >35 years of age for women.

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Carotid Artery Disease

Title: CHOICE - Carotid Stenting For High Surgical Risk Patients; Evaluating Outcomes Through the Collection of Clinical Evidence
Sponsor: Abbott Vascular
Investigator: Louis Heller, MD
Sub Investigators: L. Van-Thomas Crisco, MD, Sean Delaney, MD, Peter H'Doubler, MD, Charles Lewinstein, MD, Mark Mittenthal, MD, Mark Rheudasil, MD, Marc Unterman, MD, Joseph Zarge, MD
Contact for Referrals: Marianne Bain, RN, CRC (O) 678-843-6074 (C) 404-275-8627 or Sonya Mathewson, RN, CRC (O) 678-843-6092 (C) 404-274-2368
Purpose: To collect data about patients' medical experiences and conditions following treatment of carotid stenosis using one of Abbott Vascular's carotid stent systems and embolic protection systems.
Patient Criteria: 1) Patient is considered high risk for CEA. 2) Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.

Title: SAPPHIRE - Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy
Sponsor: Cordis Corporation
Investigator: Louis Heller, MD
Sub Investigators: L. Van-Thomas Crisco, MD, Sean Delaney, MD, Peter H'Doubler, MD, Charles Lewinstein, MD, Marc Unterman, MD, Brooks Whitney, MD, Joseph Zarge, MD
Contact for Referrals: Marianne Bain, RN, CRC (O) 678-843-6074 (C) 404-275-8627 or Sonya Mathewson, RN, CRC (O) 678-843-6092 (C) 404-274-2368
Purpose: Purpose is to estimate 30-Day MAE rate of stenting (any death, stroke or any MI) with distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients.
Patient Criteria: High-surgical risk patients with atherosclerotic disease of the carotid artery (ies).

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Heart Failure

Title: Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study (LAPTOP-HF)
Sponsor: St. Jude Medical
Investigator: John O'Connell, MD
Sub Investigators: Anshul Patel, MD, Brenda Hott, MD, Niraj Sharma, MD, Donald Jansen, MD, Kathleen Halvey, NP and Linda Kelly, NP
Contact for Referrals: Rebecca Allen, RN (O) 678-843-6081 (C) 404-275-8400
Purpose: To evaluate the safety and clinical effectiveness of the LAP Monitoring Systems linked with a physician-directed, patient self-management therapeutic strategy to limit LAP excursions in ambulatory patients with advanced heart failure (Treatment group) with a Control group receiving optimal medical therapy in a prospective randomized multicenter trial.
Patient Criteria: 1) Must be 18 years or older. 2) Ischemic or non-ischemic cardiomyopathy with either a history of reduced or preserved ejection fraction and heart failure for at least 6 months. 3) NYHA Class III documented at screening visit. 4) Receiving appropriate medical therapy for heart failure as per ACC/AHA guidelines (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and beta-blocker) for at least 3 months prior to the baseline evaluation. 5) Have a minimum of one (1) prior hospital admission within the last 12 months for acute exacerbation of HF of at least one (1) calendar date change duration requiring intravenous or invasive HF therapy. If CRT device previously implanted, the heart failure hospitalization must be ? 30 days after CRT implantation.

Title: A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (VAS) for Destination Therapy of Advanced Heart Failure (Protocol Number HW-004) (ENDURANCE STUDY)
Sponsor: Heartware Inc.
Investigator: John O'Connell, MD
Sub Investigators: Jeffrey Miller, MD, Brenda Hott, MD, Donald Jansen, MD, Kathleen Halvey, NP
Contact for Referrals: Rebecca Allen, RN, CCRC (O) 678-843-6081 (C) 404-275-8400
Purpose: To evaluate the Heartware Ventricular Assist System (VAS) for Destination Therapy in Advanced Heart Therapy.
Patient Criteria: Patients with advanced heart failure symptoms (Class IIIB or IV) who are either on optimal medical management for at least 45 out of last 60 days and failing to respond, or in Class III or Class IV heart failure for at least 14 days and dependent on intra aortic balloon pump for 7 days and/or inotropes for at least 14 days.

Title: Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients (MultiSENSE)
Sponsor: Boston Scientific
Investigator: John O'Connell, MD
Sub Investigators: Kathleen Halvey, NP, George Chang, MD, Anshul Patel, MD, David Wilson, MD, Niraj Sharma, MD, David Westerman, MD, Mohammad Kooshkabadi, MD
Contact for Referrals: Rebecca Allen, RN, CCRC (O) 678-843-6081 (C) 404-275-8400
Purpose: To collect chronic ambulatory data from multiple sensors available to CRT-D devices in order to develop algorithms for the early detection of worsening Heart Failure (HF).
Patient Criteria: 1) Currently implanted with a COGNIS device (Model N119 or N120) at least 30 days post procedure. 2) At least one documented protocol defined heart failure event within the previous 6 months or two in the previous 12 months.

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Cardiac Surgery

Title: LifeVest post CABG Registry
Sponsor: ZOLL
Principle Investigator: Averel Snyder, MD
Sub Investigators: David Langford, MD, Jeffrey Miller, MD, Steven Macheers, MD, Douglas Murphy, MD
Contact for Referrals: Michele Fielding, RN, BSN (O) 678-843-6094 (C) 404-275-8263
Purpose: To conduct a multicenter prospective registry of patients with an EF ?35% following CABG surgery in order to test hypothesis that wearable defibrillators will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death.
Patient Criteria: Patients who have had CABG surgery within 10 days and EF ?35%. Dilated cardiomyopathy or prior MI.

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Past Clinical Trials

• CYPRESS - A Prospective, Randomized, Multi-Center, Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention with the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER® Stent)
• DAPT - A Prospective, Randomized, Multi-Center, Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention with the CYPHER^® Sirolimus-eluting Coronary Stent (CYPHER^® Stent).
• BESST - Bupivacaine Effectiveness and Safety in SABER™ Trial
• DESIR-ABLE - Multi-Center Trial for the Prophylaxis of Thrombosis: An Alternative to Heparin-Based Anticoagulation (DESIR-ABLE)
• CREST - Carotid Revascularization Endarterectomy vs Stenting Trial
• SNUG II - A Randomized, Double-blind, Placebo-conrolled study of Glypromate^® in Patients undergoing Cardiopulmonary Bypass Surgery.
• RESTOR MV - Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
• AWARE - A randomized,double-blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of Ad5FGF-4 in female patients with stable angina pectoris who are not candidates for revascularization
• TAXUS PERSEUS - A Prospective Evaluation in a non- Randomized Trial of the Safety and Efficacy of the Use of the TAXUS^® Element^TM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions in Small Vessels
• MET-Test - The Effect of Ranolazine on Cardiovascular Physiology during Exercise in Ischemic Heart Disease
• The BALANCE Study - Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation. International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of the Effects of Titrated Oral Lixivaptan Capsules in Patients with Hyponatremia Associated With Heart Failure
• TAXUS PERSEUS - A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS^® Element^TM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions
• CORDIS ELITE - A Prospective, Randomized, Multi-Center, Comparison of the Cypher^® ELITE^TM and the Cypher^® Bx VELOCITY^® Sirolimus-Eluting Stent Systems
• IMPROVE-IT - Improved Reduction of Outcomes: Vytorin Efficacy International Trial
• 11) TAMARIS - A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF 4 ADMINISTRATIONS OF XRP0038/NV1FGF 4mg AT 2-WEEK INTERVALS ON AMPUTATION OR ANY DEATH IN CRITICAL LIMB ISCHEMIA
• DETERMINE - Defibrillators To Reduce Risk by Magnetic Resonance Imaging Evaluation
• RELIANT - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Trial to Assess the Efficacy and Safety of Omacor^® for the Prevention of Recurrent, Symptomatic Atrial Fibrillation
• TRA-CR - A 12 month follow-up study to Protocol No. 24779 (A double-blind, prospective, randomized, placebo-controlled study to determine the tolerability, efficacy, safety, and dose range of intramyocardial injections of G-CSF mobilized Auto-CD34+ cells for reduction of angina episodes in subjects with refractory chronic myocardial ischemia.
• RELY-ABLE - Long term multi-center extension of Dabigatran treatment in patients with AF who completed the RE-LY trial
• Ekos Teras Study - Thrombolysis with EKOS^® ultrasound for the Resolution of Arterial and Venous Occlusions Study
• ROCKET - A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Embolism in Subjects With Non-Valvular Atrial Fibrillation
• CHAMPION PCI - A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention.
• SATURN - Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin (Crestor) Versus Atorvastatin (Lipitor)
• PROTECT II - A Prospective, multi-center, randomized controlled trial of the IMPELLA^® RECOVER^® LP 2.5 System versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI
• Celtaxsys Trial - Collection of Human Tissues and/or Fluids in Patient Undergoing Surgical Oncology
• MARVEL Trial - A Phase II/III, Double-Blind, Randomized, Controlled, Multicenter Study to Assess the Safety and Cardiovascular Effects of Myocell^TM Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction (s)
• SNAP-CABG-OFF Study - A Phase 2 Study of NU172 Anticoagulation in Patients Undergoing Coronary Artery Bypass Graft Surgery OFF pump
• TIMI-50 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects with History of Atherosclerotic Disease: Thrombin Receptor Antagonist for Secondary Prevention of Atherothrombotic Ischemic Events
• ASCEND - HF - Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure
• Model 4396 Left Ventricular Lead
• BRONCHIECTASIS - Validate QOL questionnaire and to evaluate perception of symptom improvement following one course of Aztreonam for inhalation solution (AZLI) in Subjects with Bronchiestasis and Gram Negative bacteria in the airways
• TARGET - A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients with Moderate to Severe Ulcerative Colitis
• HERCULES - A prospective, non-randomized, multi-center, single-arm clinical trial to assess the safety and efficacy of the rx herculink^® elite^TM renal stent System for the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (pta) in atherosclerotic de novo or restenotic renal artery stenoses in patients with uncontrolled hypertension. Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety
• PROTECT CA - Patient Related Outcomes with Endeavor Zotarolimus Eluting Stent System
• CARDIOMEMS PHASE II - CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
• RESOLUTE - A Clinical Evaluation of the Medtronic Endeavor^® Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries with a Reference Vessel Diameter of 2.25mm to 4.2 mm
• Xience^TM V - Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study
• REVEAL - Randomized, Multi-Center, Double-blind, Placebo Controlled Trial of the Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Acute Myocardial Infarctions
• Aristotle - Apixaban for Reduction in Stroke and other thromboembolic events in Atrial Fibrillation
• CLEAR Study: Clinical Performance Evaluation of the Cholestech LDX Cardiac hsCRP Test
• TOPCOAT: Randomized Trial of Tenecteplase to Treat Severe Submassive Pulmonary Embolism
• Freedom Trial - Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel disease
• GRAVITAS - Gauging Responsiveness with A VerfyNow assay-Impact on Thrombosis and Safety
• TRACER - Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH-530348 in addition to Standard of Care in Subjects with Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome
• Hoffman-La Roche-ACS - A phase III, double-blind, randomized placebo-controlled study to evaluate the effect of R04607381 on cardiovascular (CV) risk in stable CHD patients, with a documented recent ACS
• RED-CABG - Reduction in Cardiovascular Events by AcaDesine in Subjects Undergoing CABG
• PROVIDE - Programming Implantable Cardioverter Defibrillators in Patients with Primary Prevention Indication to Prolong Time to First Shock
• LC Bead Registry - Outcomes in Surgical Oncology: A Multi-Center Database Collecting BEAD Data
• CABANA - A Carotid Stenting Boston Scientific Surveillance Program
• Radial Registry - Radial-access and Ambulatory Discharge after Interventions in Arterial Lesions: The RADIAL Registry

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Shaping Modern Medicine from Bench to Bedside

At SJTRI, we've dedicated ourselves to our mission to translate scientific discoveries into modern therapeutics for patient care. We've helped bring two drug-eluting stents to the commercial market, guided two international pharmaceutical and medical device companies into the U.S. market, and collaborated on Atlanta-based CardioMEMS' EndoSure AAA wireless pressure measurement system U.S. Food and Drug Administration approval. Unlike any other translational research institute, SJTRI employs the knowledge and expertise of both industry and academic staff, provides access to the medical capabilities and resources of the Saint Joseph's Health System, and offers state-of-the-art pre clinical research facilities. For more information about SJTRI, please visit www.sjtri.org.

What is Translational Research?

Translational research uses the findings of basic scientific research to develop practical applications for patient treatment. At SJTRI, our range of expertise includes: interventional cardiology, cardiothoracic surgery, vascular physiology and pathology, clinical cardiology, cardiac electrophysiology, and angiogenesis. Among other projects, SJTRI's current translational research investigates:

• Autologous bone marrow cell therapy for heart failure. This therapy improves heart function by removing bone marrow cells from a patient, culturing them, and transplanting them into the same patient's damaged heart muscle.
• Autologous skeletal myoblast transplant therapy for heart failure. SJTRI is one of only five institutions in the country participating in these clinical trials, in which myoblasts (cells that develop into muscle cells) are removed from a patient's thigh muscle, cultured, and implanted into the patient's damaged heart.
• Autologous connective tissue cells to treat cardiac rhythm disorders. This research focuses on reducing and even eliminating heart rhythm problems in heart attack victims by injecting connective tissue into damaged heart muscle to block the pathways of abnormal electrical impulses.

For more information about SJTRI, please visit www.sjtri.org.

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World-Class Facilities

In partnership with the Georgia Institute of Technology (Georgia Tech), SJTRI opened a state-of-the-art, 32,000-square-foot preclinical research facility in 2009 for preclinical and clinical studies, physician education and training, and regulatory assistance. This new facility features:

• Six state-of-the art surgical suites
• Two fixed catheterization laboratories
• Five wet labs for comprehensive histology, cell, and tissue research
• A robotic suite
• Preclinical preparation space for each surgical suite
• Welcoming offices and meeting spaces
• Real-time, 24/7 remote access to the laboratories through Georgia Tech's Global Learning Center
• Live and recordable audio/video feeds from the ORs, Cath labs, monitoring equipment and conference room, which can be broadcast anywhere around the globe
• Hard wired audio/visual capabilities with ability to record as well as transmit multiple live feeds from the ORs, Cath labs, monitoring equipment, and conference room; internally, across the street, or around the globe.

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Training and Education

SJTRI serves as a physical juncture for researchers and physicians to learn from each other. Saint Joseph's plays an important role in training end users on emerging treatments and devices, keeping medical professionals up-to-date on the latest discoveries in patient care. This collaboration among scientists and physicians enables researchers to identify patient needs at the bedside and work on solutions in the lab to meet them.

SJTRI's two fully functioning operating rooms and two fully functioning catheterization labs provide a realistic, tier-one facility for physician or staff training, live case exhibits, focus groups, and other educational opportunities. Additionally, the spacious facility features a full-sized conference room with seating for up to 18 boardroom style or 24 classroom style. For more about SJTRI's training and education capabilities, please visit http://www.sjtri.org/training.

International Research Fellowship

SJTRI promotes scientific development through our international fellowship program. This program provides fellows with comprehensive training in cardiovascular research and education, preparing them for careers as pioneers in the development of novel solutions for patient care. Representing a powerful tool in accelerating the process of scientific advancement and standard-of-care treatment, the program allows fellows to learn innovative techniques through close, daily interaction with SJTRI researchers whose expertise spans from cardiac surgery to regenerative medicine. For more information about SJTRI's International Research Fellowship program, please visit www.sjtri.org/preclinical-research-fellowships.