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Research Trials in the Center for Preventive Cardiology

Researchers in Northwestern Memorial Hospital's Center for Preventive Cardiology at the Bluhm Cardiovascular Institute are conducting clinical research trials to learn more about treating heart failure.

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 heart failure, are currently recruiting volunteers:

A Prospective, Randomized Study to Compare Progel® Vascular Sealant to Gelfoam® Plus as an Adjunct for the Control of Bleeding in Subjects Undergoing Thoracic Aortic Surgery

Principal Investigator:
S Chris Malaisrie, MD (profile opens in new window)
IRB Project Number:
Description of Research Trial:

This study is looking to enroll patients who are scheduled to have an aortic repair and/or aortic reconstruction surgery.  Bleeding from blood vessels is a common occurrence during or after aortic surgery.  If this bleeding is not treated, these blood vessel leaks can lead to complications and lengthen the duration of the stay in the hospital.  Bleeding from blood vessels is usually treated with a combination of stitches, staples, and/or cautery (using electricity to close the tissue) to close the tissue to stop this bleeding; however, these procedures are not always successful in stopping all of the bleeding from these blood vessels.  When these standard techniques do not completely stop this bleeding, the doctor may use additional products to stop the bleeding. 

The sponsor of the research study, Neomend, has developed a surgical sealant called Progel® Vascular Sealant, which has been previously approved by the United States Food and Drug Administration (FDA) to close air leaks that occur during open lung surgery.  The sponsor is now seeking approval from FDA for a new use of Progel® Vascular Sealant as a blood sealant during aortic thoracic (on the heart within the chest) surgery and is therefore is considered an experimental device in this study. 

Progel® Vascular Sealant is a single use device that looks like a gel and is applied to the site of suture closure or repair using a syringe like device with a spray tip forming a flexible seal over the area.  After bleeding from the blood vessel stops, the gel will stay in place.  Within 30 days of when the Progel® Vascular Sealant was applied, its components will break down in the body and the broken down material will be removed from body through urine

Approximately 160 subjects will participate in this study (approximately 107 patients will receive Progel® Vascular Sealant and approximately 53 patients who will receive the control device) at up to 20 clinical centers in the United States. 

Participation in this study will last for about 1–1 ½ months (4-6 weeks) and will involve a one-month follow-up visit after surgery.
Research Trial Contact Information:
For more information, interested participants and clinicians may contact Susan Herman at (312)926-9769 or e-mail sherman2@nmh.org or Kelly Johnston at (312) 926-7312 or e-mail kjohnst1@nmh.org

AlloCure AC 6071103

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

This study is recruiting people who will be having heart surgery that requires use of a cardio-pulmonary bypass pump (“CPB” or “the heart lung machine”), or who have already had this surgery and have acute evidence of acute kidney injury (AKI). 

Acute kidney injury (AKI) is a sudden loss of kidney function, meaning the kidneys cannot keep up with cleaning the blood of waste substances the way they need to.  AKI is a serious complication that can cause the body to hold on to too much fluid and be unable to make urine properly, and so it may require extended hospitalization and/or kidney dialysis. People that have heart surgery with use of a cardio-pulmonary bypass pump are at risk of developing AKI, although it does not happen to everyone.  Currently, there are no drugs available for AKI and the only way to treat someone with AKI is with supportive care like managing the amount of fluid they get, and possibly dialysis.  

The purpose of this research study is to find out if a new treatment, called AC607 (“Study Drug”), can help people who have had heart surgery and who develop AKI after their operation.  Researchers also want to find out if the Study Drug is safe and tolerable for patients over time. 

The Study Drug is made from human mesenchymal stem cells (hMSC).  These cells are taken from the bone marrow of healthy adult people who volunteered to donate their cells (not from embryos) then the cells are grown in an FDA-approved manufacturing facility.  Previous research in animals has shown that hMSCs protect the kidneys and reduce or prevent AKI.  Researchers hope that this type of treatment may prevent people from having severe AKI, may help to repair the kidneys after AKI develops, and may reduce the chances of dying from AKI. 

This research study includes a 90-day follow-up period after the surgery and the treatment to see how safe and effective it is, plus a 3-year extended follow-up period.  Approximately 200 people will be in this study. We hope to enroll approximately 10 patients here at Northwestern.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Catherine Crooke at (312) 695-4189 or e-mail ccrooke@nmh.org

RenalGuard CIN-RG: A Study to Evaluate RenalGuard™ System Safety and Efficacy when Compared with Standard Care in the Prevention of Contrast Induced Nephropathy in the Setting of a Catheterization Laboratory

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

The RenalGuard CIN-RG study is recruiting patients with impaired kidney function who are scheduled to undergo a catheterization procedure that may involve a percutaneous coronary intervention (PCI).  These patients may be at a higher risk for developing contrast induced nephropathy (CIN), which is kidney damage caused by exposure to the contrast agent used during the catheterization procedure.  Physicians believe that CIN can lead to further medical problems both right after the catheterization and in the future.

The purpose of this study is to determine if a new treatment, called induced diuresis (increased urine production) with matched hydration, is a safe and potentially effective way to protect the  kidneys during catheterization procedures.  The way that induced diuresis and matched hydration therapy is accomplished is by making the kidneys produce more urine than usual, then matching the amount of urine produced by replacing it with the same volume of a standard, sterile salt solution (saline).  The saline is infused (given) via a small intravenous (IV) catheter (a small tube) that is placed into a vein in the arm.  It is believed that the therapy works by more rapidly flushing the contrast agent out of the body making the kidneys at lower risk for damage.  It is also believed that by replacing only the amount of fluid produced from the body during urination, potential side effects from either putting too much or not enough fluid into the body will be prevented.

At this time, the sponsor is conducting a study to show that induced diuresis with matched hydration using The RenalGuard System (“Study Device”) is better than the current treatment in the prevention of CIN.

The trial will enroll 326 subjects at up to 30 different hospitals.  This hospital expects to enroll approximately 10 to 15 subjects.  Participation in this study is expected to last up to 90 days after the catheterization procedure is performed.  .

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 
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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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