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Cardiogenic ShockNCSINCT03677180

National Cardiogenic Shock Initiative

An observational study of Cardiogenic Shock and Acute Myocardial Infarction, run by Henry Ford Health System at 75 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
406 participants
Where
75 sitesUnited States
Study dates
19 May 2016to 31 Dec 2020
How long will I take part?
1 Year
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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:
  3. Hypotension (systolic blood pressure ≤90 mm Hg, or inotropes/vasopressors to maintain systolic blood pressure ≥90 mmHg)
  4. Signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or elevated lactate levels)
  5. Hemodynamic criteria represented by a cardiac index of <2.2 L/min/m2 or a cardiac power output ≤0.6 watts.
  6. Patient is supported with an Impella
  7. 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

Trial locations and contacts

75 sites in 1 country.

75 sites in 1 country

United States75 sites

  • Presbyterian Hospital

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Heart Hospital of Austin

    Austin, Texas, 78756

  • UAB Hospital

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Buffalo General Medical Center

    Buffalo, New York, 14203

  • Mercy Hospital of Buffalo

    Buffalo, New York, 14220

  • UVA University Hospital

    Charlottesville, Virginia, 22903

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Henry Ford Macomb Hospital

    Clinton Township, Michigan, 48038

  • Texas Health Presbyterian Hospital Dallas

    Dallas, Texas, 75231

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • Iowa Heart Center at Mercy Medical Center

    Des Moines, Iowa, 50314

  • DMC Heart Hospital

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Ascension St. John Hospital

    Detroit, Michigan, 48236

  • Elmhurst Hospital

    Elmhurst, Illinois, 60126

  • Englewood Hospital

    Englewood, New Jersey, 07631

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • San Juan Regional Medical Center

    Farmington, New Mexico, 87401

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703

  • North Florida Regional Medical Center

    Gainesville, Florida, 32605

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Spectrum Health Fred and Lena Meijer Heart Center

    Grand Rapids, Michigan, 49503

  • Excela Westmoreland Regional Hospital

    Greensburg, Pennsylvania, 15601

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Palmetto General Hospital

    Hialeah, Florida, 33016

  • Orange Park Medical Center

    Jacksonville, Florida, 32073

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • North Knoxville Medical Center

    Knoxville, Tennessee, 37849

  • Fort Sanders Regional Medical Center

    Knoxville, Tennessee, 37916

  • Physicians Regional Medical Center

    Knoxville, Tennessee, 37917

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Parkwest Regional Medical Center

    Knoxville, Tennessee, 37923

  • Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

  • St. Anthony Hospital

    Lakewood, Colorado, 80228

  • KentuckyOne Health Saint Joseph Hospital

    Lexington, Kentucky, 40504

  • CHI Health Nebraska Heart

    Lincoln, Nebraska, 68526

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • KentuckyOne Health Jewish Hospital

    Louisville, Kentucky, 40202

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Edward Hospital

    Naperville, Illinois, 60540

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

  • Hackensack Meridian Health Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Methodist Medical Center

    Oak Ridge, Tennessee, 37830

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • St. Joseph Hospital Orange

    Orange, California, 92868

  • Overland Park Regional Medical Center

    Overland Park, Kansas, 66215

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • St. Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

  • Beaumont Hospital, Royal Oak

    Royal Oak, Michigan, 48073

  • Mercy General Hospital

    Sacramento, California, 95819

  • Methodist Hospital

    San Antonio, Texas, 78229

  • Brooke Army Medical Center

    San Antonio, Texas, 78234

  • UCLA Medical Center, Santa Monica

    Santa Monica, California, 90404

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Northwest Medical Center - Springdale

    Springdale, Arkansas, 72764

  • PeaceHealth Sacred Heart Medical Center at Riverbend

    Springfield, Oregon, 97477

  • SSM Health St. Louis University Hospital

    St Louis, Missouri, 63110

  • Stamford Hospital

    Stamford, Connecticut, 06902

  • Beaumont Hospital, Troy

    Troy, Michigan, 48085

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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.

Read the 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.

Keywords
Cardiogenic shock, Mechanical circulatory support, National Cardiogenic Shock Initiative, Myocardial infarction, Heart attack, Acute MI, NCSI, National CSI, Impella, Shock, Hemodynamic Support
Medical subject headings
Shock, Cardiogenic, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Myocardial Infarction, Shock

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Survived at Discharge

    Number of Participants Who Survived at Discharge

    Measured: through study completion (hospital discharge), an average of 30 days.

Secondary outcomes (2)

  1. Number of Participants Who Survived to 30 Days Post Hospital Discharge.

    Number of Participants Who Survived to 30 Days Post Hospital Discharge.

    Measured: 30 days post-hospital discharge.

  2. Number of Participants Who Survived to 1 Year Post Hospital Discharge.

    Number of Participants Who Survived to 1 Year Post Hospital Discharge.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2018
  2. Study start19 May 2016
  3. Primary completion1 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
406 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03677180
Sponsor's protocol ID
NCSI
Other IDs
National CSI
Acronym
NCSI
Status last verified
Jun 2025
First submitted
17 Aug 2018
Last updated
1 Jul 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28335901

  • 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.

    PubMed 28040188

  • 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.

    PubMed 29266676

  • 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.

    PubMed 26884615

  • 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.

    PubMed 24419737

  • 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.

    PubMed 11176812

  • 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.

    PubMed 26724199

  • 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.

    PubMed 22920912

  • 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.

    PubMed 6059183

  • 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.

    PubMed 25277608

  • 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.

    PubMed 31025538

  • 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.

    PubMed 34011835

  • 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.

    PubMed 33606413

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiogenic Shock and Acute Myocardial Infarction, run by Henry Ford Health System at 75 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Survived at Discharge (time frame: through study completion (hospital discharge), an average of 30 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03677180, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.

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