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National Cardiogenic Shock Initiative (NCSI)

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ClinicalTrials.gov Identifier: NCT03677180
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Abiomed Inc.
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
William W. O'Neill, Henry Ford Health System

Brief Summary:
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.

Condition or disease
Cardiogenic Shock Acute Myocardial Infarction STEMI - ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI Heart Attack

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: National Cardiogenic Shock Initiative
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock




Primary Outcome Measures :
  1. Survival to discharge from hospital [ Time Frame: Hospital discharge (average= 11 days) ]
    All cause mortality at hospital discharge.


Secondary Outcome Measures :
  1. 30 Day Mortality [ Time Frame: 30 days ]
    All cause mortality at 30 days post-discharge.

  2. 1 Year Mortality [ Time Frame: 1 year ]
    All cause mortality at 1 year post-discharge


Other Outcome Measures:
  1. Use of MCS Pre-PCI [ Time Frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention) ]
    Number of patients who receive mechanical circulatory support (MCS) pre-PCI (percutaneous coronary intervention).

  2. Door to Support Time < 90 Minutes [ Time Frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention) ]
    Time from patient presentation at hospital to time that MCS (mechanical circulatory support) was started.

  3. Establish TIMI III Flow [ Time Frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention) ]
    Establishment of TIMI III (thrombolysis in myocardial infarction) coronary blood flow during index PCI (percutaneous coronary intervention) in culprit lesions.

  4. Wean off Vasopressors & Inotropes [ Time Frame: At index PCI (percutaneous coronary intervention), 12-hours post-PCI, 24-hours post-PCI ]
    Ability to wean off vasopressor & inotropic medication use in patients being treated with early MCS (mechanical circulatory support) during treatment for AMICS (acute myocardial infarction with cardiogenic shock).

  5. Maintain CPO >0.6 Watts [ Time Frame: At index PCI (percutaneous coronary intervention), 12-hours post-PCI, 24-hours post-PCI ]
    Ability to maintain a cardiac power output (CPO) measurement of > 0.6 watts.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients presenting with acute myocardial infarction and cardiogenic shock treated with mechanical circulatory support.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677180


Contacts
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Contact: Babar Basir, DO 313-916-8708 NationalCSI@hfhs.org
Contact: Michael Hacala 313-916-8708 NationalCSI@hfhs.org

  Hide Study Locations
Locations
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United States, Alabama
UAB Hospital Not yet recruiting
Birmingham, Alabama, United States, 35233
United States, Arkansas
Northwest Medical Center - Bentonville Withdrawn
Bentonville, Arkansas, United States, 72712
Washington Regional Medical Center Recruiting
Fayetteville, Arkansas, United States, 72703
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Northwest Medical Center - Springdale Recruiting
Springdale, Arkansas, United States, 72764
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
St. Joseph Hospital Orange Recruiting
Orange, California, United States, 92868
Mercy General Hospital Not yet recruiting
Sacramento, California, United States, 95819
UCLA Medical Center, Santa Monica Recruiting
Santa Monica, California, United States, 90404
United States, Colorado
St. Anthony Hospital Not yet recruiting
Lakewood, Colorado, United States, 80228
United States, Connecticut
Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06902
United States, Florida
JFK Medical Center - Main Campus Recruiting
Atlantis, Florida, United States, 33462
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
North Florida Regional Medical Center Recruiting
Gainesville, Florida, United States, 32605
Palmetto General Hospital Recruiting
Hialeah, Florida, United States, 33016
Orange Park Medical Center Recruiting
Jacksonville, Florida, United States, 32073
Jackson Memorial Hospital Not yet recruiting
Miami, Florida, United States, 33136
University of Miami Hospital Not yet recruiting
Miami, Florida, United States, 33136
United States, Georgia
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
United States, Illinois
Advocate Good Samaritan Hospital Recruiting
Downers Grove, Illinois, United States, 60515
Elmhurst Hospital Recruiting
Elmhurst, Illinois, United States, 60126
Edward Hospital Recruiting
Naperville, Illinois, United States, 60540
United States, Iowa
Iowa Heart Center at Mercy Medical Center Recruiting
Des Moines, Iowa, United States, 50314
United States, Kansas
Overland Park Regional Medical Center Recruiting
Overland Park, Kansas, United States, 66215
United States, Kentucky
KentuckyOne Health Saint Joseph Hospital Recruiting
Lexington, Kentucky, United States, 40504
KentuckyOne Health Jewish Hospital Recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01605
United States, Michigan
Henry Ford Macomb Hospital Recruiting
Clinton Township, Michigan, United States, 48038
DMC Heart Hospital Suspended
Detroit, Michigan, United States, 48201
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Ascension St. John Hospital Recruiting
Detroit, Michigan, United States, 48236
Spectrum Health Fred and Lena Meijer Heart Center Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Ascension Providence Hospital, Novi Campus Recruiting
Novi, Michigan, United States, 48374
St. Joseph Mercy Oakland Hospital Recruiting
Pontiac, Michigan, United States, 48341
Beaumont Hospital, Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Ascension Providence Hospital, Southfield Campus Recruiting
Southfield, Michigan, United States, 48075
Beaumont Hospital, Troy Recruiting
Troy, Michigan, United States, 48085
Ascension St. John Macomb-Oakland Hospital, Warren Recruiting
Warren, Michigan, United States, 48093
United States, Mississippi
North Mississippi Medical Center Suspended
Tupelo, Mississippi, United States, 38801
United States, Missouri
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
SSM Health St. Louis University Hospital Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
CHI Health Nebraska Heart Recruiting
Lincoln, Nebraska, United States, 68526
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Englewood Hospital Recruiting
Englewood, New Jersey, United States, 07631
Hackensack Meridian Health Jersey Shore University Medical Center Not yet recruiting
Neptune, New Jersey, United States, 07753
United States, New Mexico
Presbyterian Hospital Recruiting
Albuquerque, New Mexico, United States, 87106
San Juan Regional Medical Center Active, not recruiting
Farmington, New Mexico, United States, 87401
United States, New York
Buffalo General Medical Center Recruiting
Buffalo, New York, United States, 14203
Mercy Hospital of Buffalo Not yet recruiting
Buffalo, New York, United States, 14220
Vassar Brothers Medical Center Recruiting
Poughkeepsie, New York, United States, 12601
Ellis Hospital Recruiting
Schenectady, New York, United States, 12308
United States, North Carolina
Wake Forest Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
University Hospitals Cleveland Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
United States, Oregon
PeaceHealth Sacred Heart Medical Center at Riverbend Recruiting
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Mercy Fitzgerald Hospital Recruiting
Darby, Pennsylvania, United States, 19023
Excela Westmoreland Regional Hospital Recruiting
Greensburg, Pennsylvania, United States, 15601
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
United States, South Carolina
St. Francis Hospital Not yet recruiting
Greenville, South Carolina, United States, 29601
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Spartanburg Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
North Knoxville Medical Center Recruiting
Knoxville, Tennessee, United States, 37849
Fort Sanders Regional Medical Center Recruiting
Knoxville, Tennessee, United States, 37916
Physicians Regional Medical Center Completed
Knoxville, Tennessee, United States, 37917
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Parkwest Regional Medical Center Recruiting
Knoxville, Tennessee, United States, 37923
Turkey Creek Medical Center Recruiting
Knoxville, Tennessee, United States, 37934
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38104
TriStar Centennial Medical Center Recruiting
Nashville, Tennessee, United States, 37203
Methodist Medical Center Recruiting
Oak Ridge, Tennessee, United States, 37830
United States, Texas
Heart Hospital of Austin Recruiting
Austin, Texas, United States, 78756
St. David's North Austin Medical Center Recruiting
Austin, Texas, United States, 78758
Texas Health Presbyterian Hospital Dallas Recruiting
Dallas, Texas, United States, 75231
Methodist Hospital Not yet recruiting
San Antonio, Texas, United States, 78229
Brooke Army Medical Center Not yet recruiting
San Antonio, Texas, United States, 78234
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Carilion Roanoke Memorial Hospital Recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Providence Regional Medical Center - Everett Recruiting
Everett, Washington, United States, 98201
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Swedish Cherry Hill Campus Recruiting
Seattle, Washington, United States, 98122
United States, Wisconsin
Froedtert Hospital / Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Henry Ford Health System
Abiomed Inc.
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: William W O'Neill, MD Henry Ford Health System
Study Director: Babar Basir, DO Henry Ford Health System
  Study Documents (Full-Text)

Documents provided by William W. O'Neill, Henry Ford Health System:
Study Protocol  [PDF] July 31, 2018


Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: William W. O'Neill, Medical Director, Center for Structural Heart Disease, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03677180     History of Changes
Other Study ID Numbers: NCSI
National CSI ( Other Identifier: Henry Ford Health System )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William W. O'Neill, Henry Ford Health System:
Cardiogenic shock
Mechanical circulatory support
National Cardiogenic Shock Initiative
Myocardial infarction
Heart attack
Acute MI
NCSI
National CSI
Impella
Shock
Hemodynamic Support
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Shock, Cardiogenic
Infarction
Shock
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases