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National Cardiogenic Shock Initiative

National Cardiogenic Shock Initiative (NCSI)

Overview

Overview

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.

Key Inclusion Criteria

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • 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:
  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.
  • Patient is supported with an Impella
  • Patient undergoes PCI
Key Exclusion Criteria

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.

  • 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
Learn More

Learn More

To learn more, visit ClinicalTrials.Gov

Study Type

Phase: Registry

Contact Us

Contact Us

To participate in this study, please contact Darla Howard at
864-560-1042