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Researchers in Northwestern Memorial Hospital's Center for Coronary Disease at the Bluhm Cardiovascular Institute are conducting clinical research trials to learn more about treating coronary disease. The following clinical research trial(s), specific to coronary disease, are currently recruiting volunteers. Clinical research trials search for new and better ways to understand and treat disease. Participating in a clinical research trial is an informative learning experience for the volunteer. Please consider volunteering in a clinical research trial as your participation will contribute to important advancements of medical knowledge. |
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| Name of Research Trial: | Prospective, Single Blind, Randomized, Multi-Center, Study Comparing The CYPHER® ELITE™ And The CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems P07-6330 |
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| Principal Investigator: | Charles Davidson, MD |
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| IRB Project Number: | STU00001564 |
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| Description of Research Trial: | Patients with coronary artery disease undergoing percutaneous coronary intervention of one or two new lesions (blockages) have the opportunity to participate in this research study. The study will evaluate an investigational stent called the Cypher® Elite comparing it to the Cypher® Bx Velocity which is approved by the Food and Drug Administration for commercial use. Both stents are coated with a drug called sirolimus which helps to prevent renarrowing of treated arteries that is seen in some patients. The purpose of this study is to evaluate the safety and effectiveness of the new stent. Participation in this study will last for 5 years and will involve 2 follow-up visits and 6 follow-up telephone calls. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Lynne Goodreau, M.S., R.N. at (312) 926-5855 or e-mail lgoodrea@nmh.org |
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| Name of Research Trial: | A Phase 3 Clinical Trial to Assess Perfusion and Obstruction Identified by Non-invasive Technology using PB127 Ultrasound Contrast Agent in Patients with Suspected Obstructive Coronary Artery Disease |
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| Principal Investigator: | Issam Mikati, MD |
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| IRB Project Number: | STU00001626 |
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| Description of Research Trial: | This study is being done to test how well a new contrast called PB127 Ultrasound Contrast Agent (study drug) works in detecting coronary artery disease when used during an ultrasound of the heart. This study is looking for patients who have been scheduled for or have recently completed imaging of the arteries that bring blood to the heart muscle (coronary angiography). Participation in this study will involve 2 outpatient visits, each about 3 hours. |
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| Research Trial Contact Information: | Information:For more information, interested participants and clinicians may contact Karissa Fortney, MSN, BS, RN at (312) 926-4801or e-mail
k-fortney@northwestern.edu |
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| Name of Research Trial: | CARES (Contrast EchocArdiography REgistry for Safety Surveillance): A Prospective, Phase IV, Open-Label, Nonrandomized, Multicenter, Surveillance Registry Study to Evaluate The Safety of Definity in Clinical Practice. |
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| Principal Investigator: | Issam Mikati, MD |
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| IRB Project Number: | STU00002748 |
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| Description of Research Trial: | This research registry is looking for patients who are scheduled to have an echocardiogram with contrast. An echocardiogram (echo for short) is a safe and painless way of evaluating heart function that cardiologists have been using for many years. Images generated from an echo show the structure of the heart. In some instances a poor quality echo limits the cardiologist's ability to see the images clearly; therefore, the use of a contrast agent to help enhance the images is often required. The purpose of this registry study is to provide safety data to the FDA on the use of the approved contrast agent, Definity®, used routinely in clinical practice. Participation in this study will last approximately 24 hours. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Karissa Fortney, MSN, BS, RN at (312) 926-4801or e-mail kfortney@nmh.org |
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| Name of Research Trial: | Plasma Brain Natriuretic Peptide Response To Rapid Right Ventricular Pacing; The Initial Responses To Ventricular Pacing (IRVING) Study |
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| Principal Investigator: | Jason Jacobson, MD |
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| IRB Project Number: | STU00002760 |
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| Description of Research Trial: | This study is looking for patients that have a weakened left vertricle (lower chamber of the heart) and that also have a dual-chambered pacemaker or an ICD (implantable cardioverter-defibrillator). The purpose of the study is to determine the effects that single-chamber pacing and dual-chamber pacing have on the heart. Specifically, we will be measuring the levels of plasma brain natriuretic peptide (BNP) before, during and after a pacing procedure. BNP is produced by the heart and has been shown to be a sensitive and specific indicator of how hard the heart is working. Our goal is to identify patients which may benefit from one type of pacing versus another in an attempt to prevent the development of heart failure symptoms and hospitalizations for heart failure. These measurements may suggest ways to improve pacemaker/ICD treatment in patients with heart failure. Participation in this study will last for about 6 months and will involve one study visit and a follow-up phone call. Compensation and parking will be provided. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact the principal investigator, Dr. Jacobson at jasonjacobson@nmff.org or (312) 695-0054. |
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| Name of Research Trial: | A Randomized, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of AZD6140 Compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO - a study of PLATelet inhibition and patient Outcomes] |
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| Principal Investigator: | Dan Fintel, MD |
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| IRB Project Number: | STU00001616 |
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| Description of Research Trial: | This study is looking for patients who have been diagnosed with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. The purpose of this study is to compare an experimental drug called AZD6140 with clopidogrel (Plavix) to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS. Participation in this study will involve about 6 three hour outpatient visits. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Elizabeth Karpf, BSN, RN at (312) 926-1096 or e-mail ekarpf@nmh.org |
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| Name of Research Trial: | A multi-center, phase 3b, stratified, randomized, open-label clinical trial to evaluate the efficacy of Intensive Apidra®/Lantus® therapy versus Sliding Scale Insulin on infarct size in hyperglycemic subjects with Anterior STEMI (ST elevation myocardial infarction) undergoing PCI (percutaneous coronary intervention) |
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| Principal Investigator: | Charles Davidson, MD |
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| IRB Project Number: | STU00002247 |
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| Description of Research Trial: | Patients presenting to the emergency department with a heart attack (also called an acute myocardial infarction) have the opportunity to participate in this research study. Subjects will receive insulin to investigate its protective effects when given to patients having a heart attack. The purpose of the study is to determine whether maintaining close glycemic (blood sugar) control will help patients recover better from a heart attack by making the size of the heart attack smaller and reducing the loss of the heart's pumping ability. Participation in this study will last for 90 days and will involve 2 follow-up clinic visits and 1 follow-up telephone contact. Subjects will undergo two cardiac Magnetic Resonance Imagings (MRIs). One will be done 2-3 days after the percutaneous coronary intervention and the other will be done 90 days later. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Lynne Goodreau, M.S., R.N. at (312) 926-5855 or e-mail lgoodrea@nmh.org |
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Name of Research Trial:
| CT-STAT: Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment |
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| Principal Investigator: | Isaam Mikati, MD |
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| IRB Project Number: | STU00000715 |
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| Description of Research Trial: | This study is looking for patients who present to the emergency room (ER) with low to intermediate chest pain. The purpose of this study is to determine if a new test, Cardiac CT scan, is as safe and accurate as the "usual" ER testing procedures for diagnosing chest pain. Computed tomography (CT) or "cat scan" is a special procedure used for diagnostic purposes. Cardiac CT, using the newest scanners, is an improved way of looking at the coronary arteries, which supply blood to the heart muscle. If these arteries are clogged this may cause chest pain or even a heart attack. The images of the coronary arteries obtained by CT scanners (during a 5-10 minute procedure) have been shown by many studies to be accurate, especially for detecting no or minimal stenosis (narrowing) or severe stenosis (narrowing), when compared to the conventional invasive cardiac catheterization procedure. Patients will be randomized into either a control group, who receive the standard of care. or a trial group, who will receive a cardiac CT. Researchers are looking to see if using a CT scan results a faster diagnosis, which in turn will contribute to decreased cost of care. Participation in this study will last approximately 6 months and will involve two follow-up phone calls at 1 and 6 months after the ER visit. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Karissa Fortney, MSN, BS, RN at (312) 926-4801or e-mail kfortney@nmh.org |
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| Name of Research Trial: | The PACE-MI Trial: PACEmaker and Beta-Blocker Therapy after Myocardial Infarction |
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| Principal Investigator: | Dan Fintel, MD |
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| National Principal Investigator: | Jeffrey Goldberger, MD |
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| IRB Project Number: | STU00001050 |
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| Description of the Trial: | This research study is evaluating, whether following a myocardial infarction, patients with either bradycardia or heart block precluding the use of beta-blockers, have improved outcomes with a pacemaker to facilitate beta-blocker therapy. Males and females over the age of 30, who are not able to take beta-blockers after a heart attack are screened for eligibility. If qualified, subjects will be randomized to receive pacemaker and beta-blocker therapy compared to current therapy, which does not include pacemaker or beta-blocker. All subjects will be followed for two years. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Elizabeth Karpf, BSN, RN at (312) 926-1096 or e-mail ekarpf@nmh.org |
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| Sponsor: | NIH National Heart, Lung and Blood Institute |
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| Name of Research Trial: | Improvement of Dysfunctional Myocardium with Ranexa® in Ischemic Heart Disease |
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| Principal Investigator: | Edwin Wu, MD |
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| IRB Project Number: | STU00000754 |
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| Description of Research Trial: | This research study is looking for patients who have chronic angina (chest pain) and have a decreased left ventricular (lower chamber of the heart) function. The purpose of the study is to determine if Cardiac Magnetic Resonance Imaging (CMR) can be used to identify areas in the left ventricle that may not be working properly or are injured. CMR is a widely used clinical test that uses magnetic fields and radio waves rather than x-rays to provide detailed pictures of internal organs. For this study, CMR will be used to evaluate if any improvements are seen in the left ventricle after 3 months of treatment with the antianginal medication (drug used to treat chest pain), ranolazine (Ranexa®). Ranolazine is approved by the U.S. FDA for the treatment of angina. The MRI system is approved by the U.S. Food and Drug Administration (FDA) for diagnosing a broad range of conditions in all parts of the body, including the heart. However, the use of CMR to measure improvements or changes in LV function is considered experimental.
Participation in the study will last approximately 3 months and will involve a minimum of 3 visits. All of your study visits, CMR, and study medication will be provided at no cost to you. Parking will be provided free of charge. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Schnabel Samson, RN, Clinical Research Coordinator at (312) 503-1497 or e-mail
s-samson@northwestern.edu |
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| Name of Research Trial: | ACT34-CMI 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. |
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| Principal Investigator: | Charles Davidson, MD |
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| IRB Project Number: | STU00000314 |
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| Description of Research Trial: | This research study is looking for individuals with chronic cardiac ischemia. The purpose of this research study is to investigate the tolerability, safety and effectiveness of one’s own stem cells delivered with a catheter (tube) into the areas of the heart with poor blood flow. Participation in this study will require 5 outpatient visits, one 24-hr hospitalization, and 7 follow-up visits. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Sherrie Wolfe, Project Coordinator at (312) 926-3413 or e-mail s-wolfe@northwestern.edu |
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| Name of Research Trial: | The Embolic Protection with Reverse Flow (EMPiRE) Study of the GORE Neuro Protection System in Carotid Stenting of Subjects at High Risk for Carotid Endarterectomy |
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| Principal Investigator: | Mark Eskandari, MD |
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| IRB Project Number: | 1038-020 |
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Description of Research Trial:
| This research study is looking for individuals who have been diagnosed with a carotid artery narrowing:
> 80 % narrowing, with no neurological symptoms and are surgically at high-risk
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> 50% narrowing, with neurological symptoms and are surgically at high-risk
The Gore Neuro Protection System is intended to provide embolic protection during carotid artery angioplasty and stenting for subjects diagnosed with carotid artery stenosis and who have appropriate anatomy. The purpose of this study is to evaluate the safety and efficacy of Gore Neuro Protection System in the treatment of carotid artery disease with patients at high risk for carotid endarterectomy. Follow-up will occur at 1 month after procedure and will include a physical and National Institute of Health Stroke Scale, and a carotid ultrasound. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Meadows, BSN, RN at (312) 695-2928 or e-mail wmeadows@nmh.org or Mary Evans, BSN, RN at (312) 695-3410 or e-mail mevans@nmh.org |
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| Name of Research Trial: | Physiology of Heart Rate Recovery After Submaximal Exercise in Subjects with Coronary Artery Disease |
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| Principal Investigator: | Jeffrey Goldberger, MD |
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| IRB Project Number: | 0225-026 |
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| Description of Research Trial: | This research study is looking for individuals with coronary artery disease. The purpose of this research study is to investigate how the heart returns to its normal rate after moderate exercise. Participation in this study will require 3 outpatient visits and each study visit will last between 2 and 4 hours. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact the Project Coordinator, Bill Godley, at (312) 695-2525 |
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