National Cardiogenic Shock Initiative
NCSI
2 other identifiers
observational
406
1 country
75
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2016
CompletedFirst Submitted
Initial submission to the registry
August 17, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedResults Posted
Study results publicly available
July 1, 2025
CompletedJuly 1, 2025
June 1, 2025
4.5 years
August 17, 2018
December 6, 2022
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Survived at Discharge
Number of Participants Who Survived at Discharge
through study completion (hospital discharge), an average of 30 days.
Secondary Outcomes (2)
Number of Participants Who Survived to 30 Days Post Hospital Discharge.
30 days post-hospital discharge.
Number of Participants Who Survived to 1 Year Post Hospital Discharge.
1 year
Other Outcomes (5)
Use of MCS Pre-PCI
At index Cath Lab procedure/PCI (percutaneous coronary intervention)
Door to Support Time < 90 Minutes
At index Cath Lab procedure/PCI (percutaneous coronary intervention)
Number of Participants With Establishment of TIMI III Coronary Blood Flow
At index Cath Lab procedure/PCI (percutaneous coronary intervention).
- +2 more other outcomes
Eligibility Criteria
Adult patients presenting with acute myocardial infarction and cardiogenic shock treated with mechanical circulatory support.
You may qualify if:
- 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)
- Cardiogenic shock is defined as the presence of at least two of the following:
- Hypotension (systolic blood pressure ≤90 mm Hg, or inotropes/vasopressors to maintain systolic blood pressure ≥90 mmHg)
- Signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or elevated lactate levels)
- Hemodynamic criteria represented by a cardiac index of \<2.2 L/min/m2 or a cardiac power output ≤0.6 watts.
- Patient is supported with an Impella
- Patient undergoes PCI
You may not qualify if:
- Evidence of Anoxic Brain Injury
- Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes
- IABP placed prior to Impella
- Septic, anaphylactic, hemorrhagic, and neurologic causes of shock
- Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
- Active bleeding for which mechanical circulatory support is contraindicated
- Recent major surgery for which mechanical circulatory support is contraindicated
- Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
- Known left ventricular thrombus for which mechanical circulatory support is contraindicated
- Mechanical aortic prosthetic valve
- Contraindication to intravenous systemic anticoagulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henry Ford Health Systemlead
- Abiomed Inc.collaborator
- Chiesi Farmaceutici S.p.A.collaborator
Study Sites (75)
UAB Hospital
Birmingham, Alabama, 35233, United States
Washington Regional Medical Center
Fayetteville, Arkansas, 72703, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Northwest Medical Center - Springdale
Springdale, Arkansas, 72764, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
St. Joseph Hospital Orange
Orange, California, 92868, United States
Mercy General Hospital
Sacramento, California, 95819, United States
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404, United States
St. Anthony Hospital
Lakewood, Colorado, 80228, United States
Stamford Hospital
Stamford, Connecticut, 06902, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
North Florida Regional Medical Center
Gainesville, Florida, 32605, United States
Palmetto General Hospital
Hialeah, Florida, 33016, United States
Orange Park Medical Center
Jacksonville, Florida, 32073, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Elmhurst Hospital
Elmhurst, Illinois, 60126, United States
Edward Hospital
Naperville, Illinois, 60540, United States
Iowa Heart Center at Mercy Medical Center
Des Moines, Iowa, 50314, United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215, United States
KentuckyOne Health Saint Joseph Hospital
Lexington, Kentucky, 40504, United States
KentuckyOne Health Jewish Hospital
Louisville, Kentucky, 40202, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038, United States
DMC Heart Hospital
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Ascension St. John Hospital
Detroit, Michigan, 48236, United States
Spectrum Health Fred and Lena Meijer Heart Center
Grand Rapids, Michigan, 49503, United States
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48073, United States
Beaumont Hospital, Troy
Troy, Michigan, 48085, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
SSM Health St. Louis University Hospital
St Louis, Missouri, 63110, United States
CHI Health Nebraska Heart
Lincoln, Nebraska, 68526, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Englewood Hospital
Englewood, New Jersey, 07631, United States
Hackensack Meridian Health Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Presbyterian Hospital
Albuquerque, New Mexico, 87106, United States
San Juan Regional Medical Center
Farmington, New Mexico, 87401, United States
Buffalo General Medical Center
Buffalo, New York, 14203, United States
Mercy Hospital of Buffalo
Buffalo, New York, 14220, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
PeaceHealth Sacred Heart Medical Center at Riverbend
Springfield, Oregon, 97477, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, 19023, United States
Excela Westmoreland Regional Hospital
Greensburg, Pennsylvania, 15601, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
North Knoxville Medical Center
Knoxville, Tennessee, 37849, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916, United States
Physicians Regional Medical Center
Knoxville, Tennessee, 37917, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Parkwest Regional Medical Center
Knoxville, Tennessee, 37923, United States
Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
TriStar Centennial Medical Center
Nashville, Tennessee, 37203, United States
Methodist Medical Center
Oak Ridge, Tennessee, 37830, United States
Heart Hospital of Austin
Austin, Texas, 78756, United States
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
Brooke Army Medical Center
San Antonio, Texas, 78234, United States
UVA University Hospital
Charlottesville, Virginia, 22903, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Related Publications (13)
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.
PMID: 28335901BACKGROUNDBasir 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.
PMID: 28040188BACKGROUNDBasir 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.
PMID: 29266676BACKGROUNDGoldberg 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.
PMID: 26884615BACKGROUNDKolte 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.
PMID: 24419737BACKGROUNDHochman 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.
PMID: 11176812BACKGROUNDBainey 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.
PMID: 26724199BACKGROUNDThiele 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.
PMID: 22920912BACKGROUNDKillip 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.
PMID: 6059183BACKGROUNDStretch 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.
PMID: 25277608BACKGROUNDBasir 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.
PMID: 31025538RESULTLorusso 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.
PMID: 34011835DERIVEDLemor 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.
PMID: 33606413DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Given the observational nature of this study, selection bias may have contributed to the exclusion of certain patients despite aggressive measures to perform screening of consecutive patients. Similarly, reports of adverse events were self-reported without oversight or monitoring hence are prone to being under reported.
Results Point of Contact
- Title
- Dr. Mir Babar Basir
- Organization
- Henry Ford Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
William W O'Neill, MD
Henry Ford Health System
- STUDY DIRECTOR
Babar Basir, DO
Henry Ford Health System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, Center for Structural Heart Disease
Study Record Dates
First Submitted
August 17, 2018
First Posted
September 19, 2018
Study Start
May 19, 2016
Primary Completion
December 1, 2020
Study Completion
December 31, 2020
Last Updated
July 1, 2025
Results First Posted
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share