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Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock

Launched by HENRY FORD HEALTH SYSTEM · Mar 23, 2023

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

The National Cardiogenic Shock Initiative (NCSI) was an initial step in helping to provide team based protocolized care in AMICS. Over the past 5 years, further evaluation and research has helped identify additional best practices that may contribute to further improving outcomes.

Vasopressors have been identified as being independently associated with worse outcomes and MCS escalation may lead to improvement. While sites participating in the NCSI were early adopters of MCS in AMICS, MCS escalation was open ended and dictated by variable local practice patterns. This contributed to the ove...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Diagnosis of acute AMI confirmed by a medical professional, with changes in serum biomarkers or evidence of ischemic EKG changes (STEMI or NSTEMI).
  • 2. Cardiogenic Shock present as defined by the presence of 2 OR MORE of the following criteria prior to PCI:
  • Hypotension: systolic blood pressure ≤ 90mmHg at baseline (prior to PCI) or the use of inotropes or vasopressors to maintain SBP ≥ 90mmHg
  • Evidence of end organ hypoperfusion: elevated serum lactate levels (venous or arterial), cool extremities, oliguria/anuria
  • Hemodynamic criteria: Cardiac Index of \< 2.2 L/min/m2 or a cardiac power output (CPO) of ≤ 0.6 watts
  • 3. Patient underwent PCI within 12 hours of hospital presentation.
  • Exclusion Registry Exclusion Criteria:
  • AMICS patients who meet any of the following study exclusion criteria will have a limited set of data collected via a single-page Patient Exclusion Form completed and submitted within 45 days of hospital discharge, which includes the reason for exclusion, date of index PCI, and assessment of patient survival to hospital discharge:
  • 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 MCS
  • 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 MCS is contraindicated
  • 7. Recent major surgery for which MCS is contraindicated
  • 8. Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
  • 9. Known left ventricular thrombus for which MCS is contraindicated
  • 10. Mechanical aortic prosthetic valve
  • 11. Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.

About Henry Ford Health System

Henry Ford Health System is a comprehensive, nonprofit healthcare organization based in Detroit, Michigan, renowned for its commitment to advancing medical research and patient care. With a robust network of hospitals, outpatient facilities, and specialty clinics, Henry Ford Health System is dedicated to innovation in clinical trials, focusing on translating scientific discoveries into effective treatments. The organization emphasizes multidisciplinary collaboration, leveraging its extensive resources and expertise to address diverse health challenges. Through its clinical research initiatives, Henry Ford Health System aims to enhance patient outcomes and contribute to the advancement of medical knowledge on both a local and global scale.

Locations

Loma Linda, California, United States

Detroit, Michigan, United States

Washington, District Of Columbia, United States

Allentown, Pennsylvania, United States

Los Angeles, California, United States

San Antonio, Texas, United States

Knoxville, Tennessee, United States

Lakewood, Colorado, United States

Nashville, Tennessee, United States

Grand Rapids, Michigan, United States

Charlottesville, Virginia, United States

Atlanta, Georgia, United States

Edgewood, Kentucky, United States

Neptune, New Jersey, United States

Orange, California, United States

Detroit, Michigan, United States

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Mir B Basir, DO

Principal Investigator

Henry Ford Health

William W O'Neill, MD

Principal Investigator

Henry Ford Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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