N/A
N=406
National Cardiogenic Shock Initiative
Cardiogenic Shock · Acute Myocardial Infarction · STEMI - ST Elevation Myocardial Infarction · NSTEMI - Non-ST Segment Elevation MI · Heart Attack
Bottom Line
View on ClinicalTrials.gov: NCT03677180 ↗Enrolled (actual)
406
Serious AEs
22.7%
Results posted
Jul 2025
Primary outcome: Primary: Number of Participants Who Survived at Discharge — 287 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Survived at Discharge |
287 | — |
| SECONDARY Number of Participants Who Survived to 30 Days Post Hospital Discharge. |
272 | — |
| SECONDARY Number of Participants Who Survived to 1 Year Post Hospital Discharge. |
173 | — |
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.
Eligibility Criteria
Registry 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
Registry 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
- 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
Data sourced from ClinicalTrials.gov (NCT03677180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.