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Research Trials in the Center for Coronary Disease

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.

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.  The following clinical research trial(s), specific to coronary disease, are currently recruiting volunteers:

ABSORB III: Clinical Evaluation of the Absorb™ Bioresorbable Vascular Scaffold (BVS) in the Treatment of Subjects with de novo Native Coronary Artery Lesions

Principal Investigator:
Mark Ricciardi, MD (profile opens in new window)
IRB Project Number:
STU00058807
Description of Research Trial:

The purpose of this Study is to assess the safety and effectiveness of treating blockages in the coronary arteries (blood vessels in the heart) with an investigational device called Absorb™ Bioresorbable Vascular Scaffold (BVS) System (the “Study Device”) compared to a US Food and Drug Administration (FDA) approved drug-eluting stent (DES) system (the “Control Device”).

The main blood vessels that supply oxygen and nutrients to your heart are called heart arteries. Sometimes these heart arteries become narrowed so that the blood flow to the heart is decreased, which can cause pain in the chest and/or other symptoms. 

To help increase blood flow to the heart a small metal mesh tube coated with medication, called a drug-eluting stent, can be placed in the narrowed area (lesion) of the artery. A drug-eluting stent has a drug coating or filling that is meant to prevent tissue re-growth where the stent is placed. The stent helps keep the arteries open and decreases the chance of artery narrowing again. Drug-eluting stents stay in the wall of your heart artery as a permanent implant.

The Study Device is a temporary device which functions like a drug-eluting stent, but is not made out of metal. Instead it consists of a plastic scaffold made out of materials that will gradually break down over time and be absorbed into the artery wall, leaving behind no permanent implant.  The Study Device is investigational, which means that the FDA has not approved it for use. 

This is a randomized Study; participants will be randomized to receive either the Study Device or the Control Device.  Participants will have a two out of three (2/3) chance of being assigned to receive the Study Device, and a one out of three (1/3) chance of being assigned to receive the Control Device.  It is twice more likely participants will receive the Study Device than the Control Device.

The ABSORB study will enroll approximately 2250 patients at about 220 sites in the United States and outside the United States. Subject participation in this study will last approximately 5 years.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Kate Jordan at (312) 926-0840 or e-mail kjordan@nmh.org 

A Prospective, Randomized, Double-Blinded, Placebo-Controlled Phase II Trial of Intra-Coronary Infusion of AMR-001, a Bone Marrow Derived Autologous CD34+ Selected Cell Product, in Patients with Acute Myocardial Infarction “PreSERVE AMI”

Principal Investigator:
Charles Davidson, MD (profile opens in new window)
IRB Project Number:
STU00057389
Description of Research Trial:

This is a study being done to find out if using specialized cells collected from your bone marrow can preserve heart muscle function after a heart attack.    The cells (or placebo) are infused into the artery where the heart attack occurred and passes into the damaged muscle.  This study is for patients who have a recent heart attack caused by a blockage in a blood vessel in the heart. This blockage stops oxygen rich blood from reaching parts of the heart muscle which become damaged and can lead to heart failure. The process of placing bone marrow cells into the heart has not been approved by the US Food and Drug Administration and is experimental.

Patients will be assigned to one of two groups:  either AMR-001 (specialized processed bone marrow cells) or placebo (inactive substance).

Participation in the study will last approximately 36 months.  There will be 10 study visits during the 36 months. About 160 patients will take part in this study across approximately 60 sites in the US. 

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Dan Roshevsky at (312) 695-3264 or e-mail droshevs@nmh.org

4D Magnetic Resonance Imaging (MRI) Cardiovascular Flow Imaging

Principal Investigator:
Patrick McCarthy, MD (profile opens in new window)
IRB Project Number:
STU00057580
Description of Research Trial:

This study is looking for patients with known heart disease. The purpose of this study is to use new MRI technology, known as 4D MRI, to help researchers develop clearer and more accurate pictures of the heart.  MRI is a widely used non-invasive clinical test that uses magnetic fields and radio waves rather than x-rays to provide detailed pictures of internal organs, including the heart.  When a doctor looks at these images, he/she can gather information that can be used to diagnose certain diseases of the body.

Approximately 500 subjects will be enrolled in the study at Northwestern.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Berenice Hernandez at (312) 695-1991 or e-mail bhernan1@nmh.org

CANTOS (ACZ885M-2301)

Principal Investigator:
Dan J. Fintel, MD (profile opens in new window)
IRB Project Number:
STU00047633
Description of Research Trial:

The ACZ 885 study is looking for patients who have had a heart attack at least 30 days ago as well as ongoing increased inflammation in their blood vessels.

The purpose of this study is to find out if canakinumab (“study drug”) reduces inflammation and is both safe and beneficial in reducing future cardiovascular events (such as heart attacks and strokes) in patients who have had a heart attack and ongoing increased inflammation in their blood vessels. This study will also test whether or not the study drug reduces the development of Type 2 diabetes in subjects who have had abnormal blood sugar levels after their heart attack. 

Both cardiovascular disease and Type 2 diabetes (adult-onset diabetes) involve inflammation.  In cardiovascular disease, interleukin-1 beta (IL-1ß) in the bloodstream and tissues may promote further cardiovascular disease events through ongoing inflammation of the blood vessel walls. In patients with Type 2 diabetes, there is a resistance to the effects of insulin, (a hormone that regulates the movement of sugar into the body’s cells) or the body doesn't produce enough insulin to maintain a normal glucose (blood sugar) level. IL-1ß in the bloodstream and tissues is thought to contribute to decreased insulin production over time which may result in development of Type 2 diabetes.

The study drug has not yet been tested or approved for reduction of cardiovascular disease events or the development of Type 2 diabetes. Therefore, in this study canakinumab is an “investigational drug.” An “investigational drug” is one that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). 

This clinical trial will involve approximately 7,302 adult patients in about 700 study centers in 20 countries. We hope to enroll up to 8 subjects here at Northwestern University.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Maggie McCarthy at (312) 926-9874 or e-mail mmccart3@nmh.org
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This page last updated 

February 11, 2014
Feinberg School of Medicine home page

Bluhm Cardiovascular Institute - Clinical Trials Unit (CTU)
Feinberg School of Medicine
676 North Saint Clair Street, Suite 1700
Chicago, IL 60611-2969
Phone: (312) 926-4000
Email: heartresearch@northwestern.edu

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