National Cardiogenic Shock Initiative



Status:Recruiting
Conditions:Cardiology, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:May 1, 2016
End Date:May 2022
Contact:Babar Basir, DO
Email:NationalCSI@hfhs.org
Phone:313-916-8708

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This study evaluates the use of early mechanical circulatory support in patients presenting
with acute myocardial infarction and cardiogenic shock. Patients are treated according to the
National Cardiogenic Shock Initiative protocol, which emphasizes early identification of
cardiogenic shock and rapid delivery of mechanical circulatory support based on invasive
hemodynamics. All patients treated in this manner are enrolled in the National Cardiogenic
Shock registry.

Acute myocardial infarction complicated by cardiogenic shock (AMICS) is a deadly condition
with a historical in-hospital survival of only 50%. To date, the only therapy proven to
benefit patients in AMICS using data from randomized control trials has been early mechanical
reperfusion. Accordingly, current American and European guidelines confer a class IB
indication for reperfusion therapy in the setting of AMICS. Unfortunately, little progress
has been made on improving survival with subsequent therapies, including intra-aortic balloon
pump counter-pulsation (IABP). This lack of progress is worrisome since the incidence of
AMICS appears to be increasing.

With the FDA approval of Impella (Abiomed, Danvers, MA) in AMICS, a powerful new tool has
become available for hemodynamic support. Impella is a transcatheter axial flow pump,
delivered percutaneous, with the ability to provide 2.5 to 4.0 liters/minute of forward flow.
The device should provide sufficient forward cardiac flow to support vital organs in the
majority of patients who present with AMICS. Since Impella is the only percutaneous temporary
ventricular support device approved as safe and effective for use in AMICS, the use of the
device has steadily grown. Unfortunately, there is little data available to providers as to
the best practice patterns associated with the delivery and use of Impella in AMICS.

Using the most up-to-date research, a treatment algorithm for AMICS was developed and
subsequently implemented as a quality improvement initiative throughout southeast Michigan.
Patient information was gathered by each of the sites and collected in a retrospective
registry. Outcomes and results were shared during quarterly meetings and concluded with a
41-patient pilot feasibility study. This initial pilot study revealed a 76% survival to
discharge, a significant improvement compared to prior historical controls.

Given the promising outcomes, leaders from around the world have implemented the treatment
algorithm in their local clinical practices with similar results. The investigators have
therefore launched the National Cardiogenic Shock Initiative (NCSI). The aim of the NCSI is
to bring together experienced centers across the nation who are experts in mechanical
reperfusion therapies and have a large experience with the use of mechanical circulatory
support devices to systematize care in AMICS.

Our goal is to dramatically decrease the duration patients remain in cardiogenic shock and
attempt to decrease total usage and duration of vasopressors and ionotropic agents. The
investigators aim to further demonstrate that rapid delivery of mechanical circulatory
support will improve hemodynamics, reverse the spiraling neuro-hormonal cascade associated
with cardiogenic shock, allowing clinicians to decrease use of vasopressors and inotropic
agents and ultimately improve survival.

Healthcare systems that have agreed to adopt the NCSI treatment algorithm are being asked to
participate in this prospective registry so that patient outcomes can be analyzed.
Participating investigators will be asked to voluntarily provide data from patients
completing the treatment algorithm to be included in the NCSI Registry.

Registry Inclusion Criteria:

1. Symptoms of acute myocardial infarction (AMI) with ECG and/or biomarker evidence of
S-T elevation myocardial infarction (STEMI) or non-S-T elevation myocardial infarction
(NSTEMI)

2. Cardiogenic shock is defined as the presence of at least two of the following:

1. Hypotension (systolic blood pressure ≤90 mm Hg, or inotropes/vasopressors to
maintain systolic blood pressure ≥90 mmHg)

2. Signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or
elevated lactate levels)

3. Hemodynamic criteria represented by a cardiac index of <2.2 L/min/m2 or a cardiac
power output ≤0.6 watts.

3. Patient is supported with an Impella

4. Patient undergoes PCI

Registry Exclusion Criteria:

1. Evidence of Anoxic Brain Injury

2. Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of
spontaneous circulation (ROSC) is not achieved within 30 minutes

3. IABP placed prior to Impella

4. Septic, anaphylactic, hemorrhagic, and neurologic causes of shock

5. Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax,
myocarditis, tamponade, etc.)

6. Active bleeding for which mechanical circulatory support is contraindicated

7. Recent major surgery for which mechanical circulatory support is contraindicated

8. Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute
papillary muscle rupture)

9. Known left ventricular thrombus for which mechanical circulatory support is
contraindicated

10. Mechanical aortic prosthetic valve

11. Contraindication to intravenous systemic anticoagulation
We found this trial at
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Stamford, Connecticut 06904
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800 Washington St
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(617) 636-5000
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330 Brookline Ave
Boston, Massachusetts 02215
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
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Atlantis, Florida 33462
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12221 North Mopac Expressway
Austin, Texas 78758
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Austin, Texas 78756
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Bentonville, Arkansas 72712
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Browns Mills, New Jersey 08015
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Buffalo, New York 14214
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Buffalo, New York 14203
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
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Clearwater, Florida 33756
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Clinton Township, Michigan 48038
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Darby, Pennsylvania 19023
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Detroit, Michigan 48201
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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22101 Moross Road
Detroit, Michigan 48236
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Downers Grove, Illinois
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Elmhurst, Illinois 60126
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Englewood, New Jersey 07631
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Everett, Washington 98201
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Fayetteville, Arkansas 72703
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Gainesville, Florida 32605
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743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
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Greensburg, Pennsylvania 15601
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Greenville, South Carolina 29601
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701 Grove Rd
Greenville, South Carolina 29605
(864) 455-7000
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Hialeah, Florida
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Jacksonville, Florida 32073
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
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3535 Southern Blvd
Kettering, Ohio 45429
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1924 Alcoa Highway
Knoxville, Tennessee 37916
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Knoxville, Tennessee 37917
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Lakewood, Colorado 80228
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1 Saint Joseph Drive
Lexington, Kentucky 40504
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Lincoln, Nebraska 68526
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11234 Anderson St
Loma Linda, California 92354
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Los Angeles, California 90095
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Memphis, Tennessee 38104
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
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Naperville, Illinois 60566
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2300 Patterson Street
Nashville, Tennessee 37203
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990 Oak Ridge Turnpike
Oak Ridge, Tennessee 37830
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Orange, California 92868
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Overland Park, Kansas 66215
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
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Pontiac, Michigan 48341
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Poughkeepsie, New York 12601
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
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Roanoke, Virginia 24033
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Royal Oak, Michigan 48314
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Sacramento, California 95819
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3660 Vista Avenue
Saint Louis, Missouri 63110
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San Antonio, Texas 78234
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Santa Monica, California 90404
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2210 Troy Schenectady Road
Schenectady, New York 12309
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Seattle, Washington 98122
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
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Springdale, Arkansas 72764
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44201 Dequindre Road
Troy, Michigan 48085
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Tupelo, Mississippi 38801
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Winston-Salem, North Carolina 27157
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Wynnewood, Pennsylvania 19096
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