Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04985708
Eligibility Criteria:
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)
* Systolic blood pressure \< 90mm at baseline or use of inotropes or vasopressors to maintain SBP \> 90 + LVEDP \> 15
* Evidence of end organ hypoperfusion
* 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 in 30 minutes
* IABP placed prior to Impella
* Patient is already supported with an 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04985708
Study Brief:
Protocol Section:
NCT04985708