National Cardiogenic Shock Initiative

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

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

To learn more, visit ClinicalTrials.Gov

Study Type

Phase: Registry