National Cardiogenic Shock Initiative (NCSI)

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.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction; Cardiogenic Shock; NSTEMI - Non-ST Segment Elevation MI; Heart Attack; STEMI - ST Elevation Myocardial Infarction

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.

• Study Type: Observational
• Enrollment (Actual): 406

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Hospital
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Washington Regional Medical Center
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
    • Springdale, Arkansas, United States, 72764
      • Northwest Medical Center - Springdale
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Orange, California, United States, 92868
      • St. Joseph Hospital Orange
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
    • Santa Monica, California, United States, 90404
      • UCLA Medical Center, Santa Monica
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • St. Anthony Hospital
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Stamford Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Gainesville, Florida, United States, 32605
      • North Florida Regional Medical Center
    • Hialeah, Florida, United States, 33016
      • Palmetto General Hospital
    • Jacksonville, Florida, United States, 32073
      • Orange Park Medical Center
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • Illinois
    • Elmhurst, Illinois, United States, 60126
      • Elmhurst Hospital
    • Naperville, Illinois, United States, 60540
      • Edward Hospital
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Heart Center at Mercy Medical Center
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Overland Park Regional Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • KentuckyOne Health Saint Joseph Hospital
    • Louisville, Kentucky, United States, 40202
      • KentuckyOne Health Jewish Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Henry Ford Macomb Hospital
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48236
      • Ascension St. John Hospital
    • Detroit, Michigan, United States, 48201
      • DMC Heart Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Fred and Lena Meijer Heart Center
    • Pontiac, Michigan, United States, 48341
      • St. Joseph Mercy Oakland Hospital
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital, Royal Oak
    • Troy, Michigan, United States, 48085
      • Beaumont Hospital, Troy
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
    • Saint Louis, Missouri, United States, 63110
      • SSM Health St. Louis University Hospital
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • CHI Health Nebraska Heart
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital
    • Neptune, New Jersey, United States, 07753
      • Hackensack Meridian Health Jersey Shore University Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Presbyterian Hospital
    • Farmington, New Mexico, United States, 87401
      • San Juan Regional Medical Center
  • New York
    • Buffalo, New York, United States, 14203
      • Buffalo General Medical Center
    • Buffalo, New York, United States, 14220
      • Mercy Hospital of Buffalo
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
  • Oregon
    • Springfield, Oregon, United States, 97477
      • PeaceHealth Sacred Heart Medical Center at Riverbend
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Darby, Pennsylvania, United States, 19023
      • Mercy Fitzgerald Hospital
    • Greensburg, Pennsylvania, United States, 15601
      • Excela Westmoreland Regional Hospital
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hospital
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
    • Knoxville, Tennessee, United States, 37934
      • Turkey Creek Medical Center
    • Knoxville, Tennessee, United States, 37916
      • Fort Sanders Regional Medical Center
    • Knoxville, Tennessee, United States, 37849
      • North Knoxville Medical Center
    • Knoxville, Tennessee, United States, 37917
      • Physicians Regional Medical Center
    • Knoxville, Tennessee, United States, 37923
      • Parkwest Regional Medical Center
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital
    • Nashville, Tennessee, United States, 37203
      • TriStar Centennial Medical center
    • Oak Ridge, Tennessee, United States, 37830
      • Methodist Medical Center
  • Texas
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin
    • Dallas, Texas, United States, 75231
      • Texas Health Presbyterian Hospital Dallas
    • San Antonio, Texas, United States, 78234
      • Brooke Army Medical Center
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • UVA University Hospital
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients presenting with acute myocardial infarction and cardiogenic shock treated with mechanical circulatory support.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival to discharge from hospital	All cause mortality at hospital discharge.	Hospital discharge (average= 11 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 Day Mortality	All cause mortality at 30 days post-discharge.	30 days
1 Year Mortality	All cause mortality at 1 year post-discharge	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of MCS Pre-PCI	Number of patients who receive mechanical circulatory support (MCS) pre-PCI (percutaneous coronary intervention).	At index Cath Lab procedure/PCI (percutaneous coronary intervention)
Door to Support Time < 90 Minutes	Time from patient presentation at hospital to time that MCS (mechanical circulatory support) was started.	At index Cath Lab procedure/PCI (percutaneous coronary intervention)
Establish TIMI III Flow	Establishment of TIMI III (thrombolysis in myocardial infarction) coronary blood flow during index PCI (percutaneous coronary intervention) in culprit lesions.	At index Cath Lab procedure/PCI (percutaneous coronary intervention)
Wean off Vasopressors & Inotropes	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).	At index PCI (percutaneous coronary intervention), 12-hours post-PCI, 24-hours post-PCI
Maintain CPO >0.6 Watts	Ability to maintain a cardiac power output (CPO) measurement of > 0.6 watts.	At index PCI (percutaneous coronary intervention), 12-hours post-PCI, 24-hours post-PCI

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Chiesi Farmaceutici S.p.A.; Abiomed Inc.
• Investigators: Study Director: Babar Basir, DO, Henry Ford Health System

Publications and helpful links

General Publications

• Killip T 3rd, Kimball JT. Treatment of myocardial infarction in a coronary care unit. A two year experience with 250 patients. Am J Cardiol. 1967 Oct;20(4):457-64. doi: 10.1016/0002-9149(67)90023-9. No abstract available.
• Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.
• Hochman JS, Sleeper LA, White HD, Dzavik V, Wong SC, Menon V, Webb JG, Steingart R, Picard MH, Menegus MA, Boland J, Sanborn T, Buller CE, Modur S, Forman R, Desvigne-Nickens P, Jacobs AK, Slater JN, LeJemtel TH; SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. One-year survival following early revascularization for cardiogenic shock. JAMA. 2001 Jan 10;285(2):190-2. doi: 10.1001/jama.285.2.190.
• O'Neill W, Basir M, Dixon S, Patel K, Schreiber T, Almany S. Feasibility of Early Mechanical Support During Mechanical Reperfusion of Acute Myocardial Infarct Cardiogenic Shock. JACC Cardiovasc Interv. 2017 Mar 27;10(6):624-625. doi: 10.1016/j.jcin.2017.01.014. No abstract available.
• Basir MB, Schreiber TL, Grines CL, Dixon SR, Moses JW, Maini BS, Khandelwal AK, Ohman EM, O'Neill WW. Effect of Early Initiation of Mechanical Circulatory Support on Survival in Cardiogenic Shock. Am J Cardiol. 2017 Mar 15;119(6):845-851. doi: 10.1016/j.amjcard.2016.11.037. Epub 2016 Dec 18.
• Basir MB, Schreiber T, Dixon S, Alaswad K, Patel K, Almany S, Khandelwal A, Hanson I, George A, Ashbrook M, Blank N, Abdelsalam M, Sareen N, Timmis SBH, O'Neill Md WW. Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: The Detroit cardiogenic shock initiative. Catheter Cardiovasc Interv. 2018 Feb 15;91(3):454-461. doi: 10.1002/ccd.27427. Epub 2017 Dec 20.
• Goldberg RJ, Makam RC, Yarzebski J, McManus DD, Lessard D, Gore JM. Decade-Long Trends (2001-2011) in the Incidence and Hospital Death Rates Associated with the In-Hospital Development of Cardiogenic Shock after Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2016 Mar;9(2):117-25. doi: 10.1161/CIRCOUTCOMES.115.002359. Epub 2016 Feb 16.
• Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, Fonarow GC. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States. J Am Heart Assoc. 2014 Jan 13;3(1):e000590. doi: 10.1161/JAHA.113.000590.
• Bainey KR, Armstrong PW. Transatlantic Comparison of ST-Segment Elevation Myocardial Infarction Guidelines: Insights From the United States and Europe. J Am Coll Cardiol. 2016 Jan 19;67(2):216-229. doi: 10.1016/j.jacc.2015.11.010. Epub 2015 Dec 23.
• Stretch R, Sauer CM, Yuh DD, Bonde P. National trends in the utilization of short-term mechanical circulatory support: incidence, outcomes, and cost analysis. J Am Coll Cardiol. 2014 Oct 7;64(14):1407-15. doi: 10.1016/j.jacc.2014.07.958.
• Basir MB, Kapur NK, Patel K, Salam MA, Schreiber T, Kaki A, Hanson I, Almany S, Timmis S, Dixon S, Kolski B, Todd J, Senter S, Marso S, Lasorda D, Wilkins C, Lalonde T, Attallah A, Larkin T, Dupont A, Marshall J, Patel N, Overly T, Green M, Tehrani B, Truesdell AG, Sharma R, Akhtar Y, McRae T 3rd, O'Neill B, Finley J, Rahman A, Foster M, Askari R, Goldsweig A, Martin S, Bharadwaj A, Khuddus M, Caputo C, Korpas D, Cawich I, McAllister D, Blank N, Alraies MC, Fisher R, Khandelwal A, Alaswad K, Lemor A, Johnson T, Hacala M, O'Neill WW; National Cardiogenic Shock Initiative Investigators. Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1173-1183. doi: 10.1002/ccd.28307. Epub 2019 Apr 25.
• Lorusso R. First Myocardial Resting or First Myocardial Revascularization for Cardiogenic Shock After Acute Myocardial Infarction-Related Cardiac Arrest? Still a Hamlet Dilemma...Now, With Some More Clues.... Crit Care Med. 2021 Jun 1;49(6):999-1000. doi: 10.1097/CCM.0000000000004932. No abstract available.
• Lemor A, Basir MB, Gorgis S, Todd J, Marso S, Gelormini J, Akhtar Y, Baker J, Chahin J, Abdul-Waheed M, Thukral N, O'Neill W. Impact of Age in Acute Myocardial Infarction Cardiogenic Shock: Insights From the National Cardiogenic Shock Initiative. Crit Pathw Cardiol. 2021 Sep 1;20(3):163-167. doi: 10.1097/HPC.0000000000000255.

Helpful Links

• National Cardiogenic Shock Initiative Website - Henry Ford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Shock; Myocardial infarction; Impella; Cardiogenic shock; Mechanical circulatory support; National Cardiogenic Shock Initiative; Heart attack; Acute MI; NCSI; National CSI; Hemodynamic Support
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: NCSI; National CSI (Other Identifier: Henry Ford Health System)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No