National Cardiogenic Shock Initiative (NCT03677180) | Clinical Trial Compass
CompletedNot Applicable
National Cardiogenic Shock Initiative
United States406 participantsStarted 2016-05-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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