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

Use our guide to learn which trials are right for you!

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
85
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
1500 Northwest 12th Avenue # 106
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
?
mi
from
Allentown, PA
Click here to add this to my saved trials
Atlantis, Florida 33462
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
12221 North Mopac Expressway
Austin, Texas 78758
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78756
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bentonville, Arkansas 72712
?
mi
from
Bentonville, AR
Click here to add this to my saved trials
Browns Mills, New Jersey 08015
?
mi
from
Browns Mills, NJ
Click here to add this to my saved trials
Buffalo, New York 14214
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Buffalo, New York 14203
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Clinton Township, Michigan 48038
?
mi
from
Clinton Township, MI
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Darby, Pennsylvania 19023
?
mi
from
Darby, PA
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
22101 Moross Road
Detroit, Michigan 48236
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Downers Grove, Illinois
?
mi
from
Downers Grove, IL
Click here to add this to my saved trials
Elmhurst, Illinois 60126
?
mi
from
Elmhurst, IL
Click here to add this to my saved trials
Englewood, New Jersey 07631
?
mi
from
Englewood, NJ
Click here to add this to my saved trials
Everett, Washington 98201
?
mi
from
Everett, WA
Click here to add this to my saved trials
Farmington, New Mexico 87401
?
mi
from
Farmington, NM
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
Gainesville, Florida 32605
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
Greensburg, Pennsylvania 15601
?
mi
from
Greensburg, PA
Click here to add this to my saved trials
Greenville, South Carolina 29601
?
mi
from
Greenville, SC
Click here to add this to my saved trials
701 Grove Rd
Greenville, South Carolina 29605
(864) 455-7000
Greenville Memorial Hospital Greenville Memorial Medical Campus is a regional referral center for the diagnosis...
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Hialeah, Florida
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Jacksonville, Florida 32073
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
?
mi
from
Kettering, OH
Click here to add this to my saved trials
1924 Alcoa Highway
Knoxville, Tennessee 37916
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Knoxville, Tennessee 37917
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Knoxville, Tennessee 37923
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Knoxville, Tennessee 37934
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lakewood, Colorado 80228
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
1 Saint Joseph Drive
Lexington, Kentucky 40504
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Lincoln, Nebraska 68526
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Memphis, Tennessee 38104
?
mi
from
Memphis, TN
Click here to add this to my saved trials
1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
University of Miami Hospital The University of Miami changed the face of modern health care...
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Naperville, Illinois 60566
?
mi
from
Naperville, IL
Click here to add this to my saved trials
2300 Patterson Street
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
?
mi
from
Novi, MI
Click here to add this to my saved trials
990 Oak Ridge Turnpike
Oak Ridge, Tennessee 37830
?
mi
from
Oak Ridge, TN
Click here to add this to my saved trials
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Overland Park, Kansas 66215
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Pontiac, Michigan 48341
?
mi
from
Pontiac, MI
Click here to add this to my saved trials
Poughkeepsie, New York 12601
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
?
mi
from
Providence, RI
Click here to add this to my saved trials
Roanoke, Virginia 24033
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Royal Oak, Michigan 48314
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Sacramento, California 95819
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
3660 Vista Avenue
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78234
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
2210 Troy Schenectady Road
Schenectady, New York 12309
?
mi
from
Schenectady, NY
Click here to add this to my saved trials
Seattle, Washington 98122
?
mi
from
Seattle, WA
Click here to add this to my saved trials
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Southfield, MI
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
Springdale, Arkansas 72764
?
mi
from
Springdale, AR
Click here to add this to my saved trials
?
mi
from
Springfield, OR
Click here to add this to my saved trials
Stamford, Connecticut 06904
?
mi
from
Stamford, CT
Click here to add this to my saved trials
44201 Dequindre Road
Troy, Michigan 48085
?
mi
from
Troy, MI
Click here to add this to my saved trials
Tupelo, Mississippi 38801
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
?
mi
from
Warren, MI
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Worcester, Massachusetts 01605
?
mi
from
Worcester, MA
Click here to add this to my saved trials
Wynnewood, Pennsylvania 19096
?
mi
from
Wynnewood, PA
Click here to add this to my saved trials