|
|
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. |
|
| Name of Research Trial: | Appraise II |
| |
| Principal Investigator: | Dan Fintel, MD |
| |
| IRB Project Number: | STU00010650 |
| |
| Description of Research Trial: | This study is being done to determine if the study drug, apixaban, when given in addition to standard treatment to subjects who recently experienced unstable agina (chest pain due to decreased oxygen being supplied to the heart) or a heart attack, is safe and can prevent further cardiovascular events, such as another heart attack, unstable agina, or stroke (occurs when blood flow to a region of the brain is obstructed and may result in death of brain tissue). Participation is this study will last approximately 34 months. |
| |
| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Elizabeth Karpf, BSN, RN at (312) 926-6106 or e-mail ekarpf@northwestern.edu |
| |
|
| Name of Research Trial: | A Phase IV, Open-Label Safety Evaluation of the Effect of DEFINITY on Pulmonary Artery Hemodynamics in Patients with Normal and Increased Pulmonary Artery Pressure |
| |
| Principal Investigator: | Issam Mikati, MD |
| |
| IRB Project Number: | STU00011735 |
| |
| Description of Research Trial: | Individuals coming to Northwestern Memorial Hospital for a right heart catheterization will be eligible to be in this clinical trial that aims to obtain information about how a contrast agent, called DEFINITY, affects blood flow in the artery that takes blood from the heart to the lungs. The study will also assess the safety of the drug and any affects it may have on your immune system. About 30 patients are expected to take part in the study at up to 6 sites in the United States. The total duration of participation in this study is expected to be about 4 to 7 days. It is important to note that the study drug has been approved by the U.S. Food and Drug Administration for use in humans for heart imaging. Participation in this study will last approximately 4-7 days. |
| |
| Research Trial Contact Information: | For more information, interested participants and clinicians may contact the Bluhm Cardiovascular Institute's Clinical Trials Unit at (312) 926-4000. |
| |
|
| Name of Research Trial: | Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation (DETERMINE trial) |
| |
| Principal Investigator: | Jeffrey Goldberger, MD |
| |
| IRB Project Number: | STU00000623 |
| |
| Description of Research Trial: | Sudden Cardiac Death (SCD) is a sudden, unexpected death that occurs when electrical impulses in a diseased heart become very irregular. This abnormal heart rhythm (arrhythmia) causes the heart to suddenly stop beating. SCD is the largest cause of natural death in the United States with more than 80% of events occurring in individuals with coronary artery disease (CAD) resulting in 325,000 deaths each year - or 890 fatalities each day. Researchers at Northwestern University Feinberg School of Medicine are looking for patients with CAD who have had, or are scheduled to have, a cardiac MRI. Cardiac MRI is used to evaluate the heart's structure and function and may be able to identify characteristics of the heart that increase a patient's risk for SCD. The purpose of the study is to see if cardiac MRI results can predict SCD, and if, implantable cardioverter defibrillator (ICD) therapy in combination with medical therapy improves survival in patients with coronary artery disease compared to medical therapy alone. An ICD is an electronic, battery-powered device that is surgically implanted underneath the skin, most often, near the collarbone. The ICD senses or detects an abnormal fast heart rhythm and delivers an electrical pulse to your heart to help your heart beat regularly again. The point of entry for all patients in the DETERMINE trial is the Registry. Participation in the registry will involve the collection and review of medical tests that the patient is about to undergo or has already completed to assess the extent of heart muscle damage. The Registry will also include: one blood draw, an ECG, a medical history interview and answering a follow-up questionnaire mailed to patient every 6 months until the end of the study. Patients who qualify for second portion of the trial and agree to participate, will be randomly assigned to receive either an ICD device (in addition to present medical therapy) or will continue with standard medical therapy alone. Additionally, we will follow-up with all patients every 6 months until the study ends. |
| |
| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Trocchio, RN at (312) 695-0045 or e-mail wtrocchi@nmh.org |
| |
|
| Name of Research Trial: | Virtual cardiac electrophysiologic testing for sudden death risk stratification |
| |
| Principal Investigator: | Jason Ng, PhD |
| |
| IRB Project Number: | STU00004691 |
| |
| Description of Research Trial: | This study seeks two groups of individuals. Those who are healthy to serve as "control subjects" and those who have a history of a heart attack and will be undergoing electrophysiology testing and cardiac MRIs as part of their medical treatment. The goal of this study is to improve the ability to identify patients with Coronary Artery Disease (CAD) who are at risk for sudden cardiac death. Currently, there is no single test or method to identify CAD patients who have a high risk and exclude patients who have a low risk for sudden cardiac death. The researchers will be collecting data from cardiac MRIs and electrocardiograms (ECGs) to develop a "virtual" electrophysiology testing tool for this purpose. As a subject in this study, you will have a cardiac MRI if you have not already had one. Or if you have had one, give your permission to collect information from your cardiac MRIs and ECGs. Participation in this study will last through one clinic visit and cardiac MRI if applicable. |
| |
| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Jason Ng, Ph.D. at (312) 926-1927 or e-mail jsnng@northwestern.edu |
| |
|
| Name of Research Trial: | Plasma Brain Natriuretic Peptide Response To Rapid Right Ventricular Pacing; The Initial Responses To Ventricular Pacing (IRVING) Study |
| |
| Principal Investigator: | Jason Jacobson, MD |
| |
| IRB Project Number: | STU00002760 |
| |
| 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. |
| |
| 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. |
| |
|
| Name of Research Trial: | The PACE-MI Trial: PACEmaker and Beta-Blocker Therapy after Myocardial Infarction |
| |
| Principal Investigator: | Dan Fintel, MD |
| |
| National Principal Investigator: | Jeffrey Goldberger, MD |
| |
| IRB Project Number: | STU00001050 |
| |
| 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. |
| |
| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Elizabeth Karpf, BSN, RN at (312) 926-6106 or e-mail ekarpf@northwestern.edu |
| |
| Sponsor: | NIH National Heart, Lung and Blood Institute |
| |
|
| 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. |
| |
| Principal Investigator: | Charles Davidson, MD |
| |
| IRB Project Number: | STU00000314 |
| |
| 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. |
| |
| 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 |
| |
|
| 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 |
| |
| Principal Investigator: | Mark Eskandari, MD |
| |
| IRB Project Number: | 1038-020 |
| |
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
or
> 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. |
| |
| 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 Anna Busman at (312) 695-3410 or e-mail mailto:a-busman@northwestern.edu |
| |
|
| |
