Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy



Status:Recruiting
Conditions:Cardiology, Cardiology, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:6/4/2016
Start Date:November 2013
Contact:Hiroo Takayama, MD, PhD
Email:ht2225@cumc.columbia.edu
Phone:212-305-0828

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The purpose of this study is to gather information on patients who have heart failure and
are eligible for one of the following two procedures: 1) mechanical support, i.e.
ventricular assist device (VAD) or 2) heart transplant. the study seeks to determine which
patient populations benefit from heart transplant or ventricular assist device. This will
allow to offer the state-of-the-art care to the patients in heart failure.

Cardiogenic shock (CS) develops in the end stage of various etiologies of heart failure and
continues to hold high mortality; ranging from 50 to 80%. Expert consensus recommends use of
more powerful mechanical circulatory support device (MCSD) in this patient population;
however, scientific evidence has been anecdotal relying on mostly single-center small case
series and, more fundamentally, because there is no unified definition to grade the severity
of the highly heterogeneous condition CS. Well-designed studies are warranted to precisely
characterize the various "phenotypes" of CS as well as the role of MCSD in this condition
with still excessive mortality.

This multicenter registry will be the first multicenter large-scale registry focused on
mechanical circulatory support (MCS) therapy for CS. The fundamental goal of RESCUE is to
advance the understanding and application of MCSD in order to improve the persistently
dismal survival of patients with CS with the following intents:

1. Elucidate current indication and outcomes of MCSD use in CS.

2. Redefine CS with better description of this disease entity, which will allow better
prediction of outcomes, selection of treatment strategy, and comparison and design of
studies.

3. Facilitate the refinement of patient selection to maximize outcomes with current and
new device options.

4. Improve and expedite new device clinical trials by providing historical control data.

5. Develop consensus "best practice" guidelines to improve clinical management by reducing
short and long-term complications of MCSD therapy.

Inclusion Criteria:

- Adult patients who receive any MCSD including Veno-Arterial Extracorporeal Membrane
Oxygenation (VA ECMO), surgical VAD, and percutaneous VAD, used to treat CS on or
after 9/30/10. Intraaortic balloon pumping (IABP) is not considered an MCSD in this
Registry.

- Adult patients who have signed informed consent. For patients who are too ill to give
informed consent the health care proxy of the patient or next of kin will be
approached for the informed consent.

Exclusion Criteria:

- patients younger than 18 years of age.
We found this trial at
7
sites
Valhalla, New York 10595
Phone: 914-493-8793
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Aurora, Colorado 80045
Phone: 720-848-9745
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-681-5925
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Minneapolis, Minnesota 55407
Phone: 612-863-3900
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Minneapolis, MN
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Hiroo Takayama, MD, PHD
Phone: 212-305-0828
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Phone: 973-926-7904
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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St Louis, Missouri 63110
Phone: 314-362-8008
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St Louis, MO
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