The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella CP during percutaneous coronary intervention (PCI) and who are managed with Impella best practices while receiving guideline-directed standard of care. This prospective, multicenter study will enroll up to 250 hemodynamically unstable patients with cardiogenic shock of less than 12 hours duration and acute myocardial infarction (AMI) of less than 24 hours duration. Cardiogenic shock will be confirmed by tissue hypoperfusion (lactate ≥ 2.5mmol/L and/or SvO2 \<55% with a normal PaO2) and systolic blood pressure \<100 mmHg and/or need for vasopressor therapy (dopamine/norepinepherine or epinephrine). Patients will be assessed for various safety endpoints, including a composite safety endpoint involving major bleeding, acute limb ischemia, and acute kidney injury. Secondary endpoints will evaluate all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), and hospitalizations through 1-year post-Impella implant. All patients presenting with AMICS at study sites will be screened for inclusion in the study after hospital discharge (or after death, if prior to hospital discharge). IRB approved consent waiver will be used to collect data from electronic health records from; Impella placement to discharge and post-discharge at 30 days post-Impella implant, 6 months post-Impella implant, and 1 year post-Impella implant.
Study Type
OBSERVATIONAL
Enrollment
250
US commercially approved Impella CP is the device that study inclusion will be based on. Only patients with AMICS who receive Impella CP as the first Impella device after cardiogenic shock onset will be included in the study.
St. Joseph Hospital Orange
Orange, California, United States
RECRUITINGAscension via Christi
Wichita, Kansas, United States
NOT_YET_RECRUITINGNew Mexico Heart
Albuquerque, New Mexico, United States
RECRUITINGComposite Safety
Composite safety endpoint (major bleeding, acute limb ischemia, or acute kidney injury requiring renal replacement therapy)
Time frame: All in-hospital events through discharge, an average of 15 days
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: Up to 1 year post-Impella implant
All-cause mortality
Time frame: Up to 1 year post-Impella implant
Cardiovascular death
Time frame: Up to 1 year post-Impella implant
Cardiovascular hospitalizations
Time frame: Up to 1 year post-Impella implant
Heart failure hospitalizations
Time frame: Up to 1 year post-Impella implant
Heart transplant or durable LVAD implantation
Time frame: Up to 1 year post-Impella implant
Any new renal replacement therapy (RRT)
Time frame: Up to 1 year post-Impella implant
Acute kidney injury (AKI)
Time frame: In-hospital through discharge, up to 15 days
Major bleeding
Time frame: In-hospital through discharge, up to 15 days
Hemolysis
Time frame: In-hospital through discharge, up to 15 days
Acute limb ischemia (ALI)
Time frame: In-hospital through discharge, up to 15 days
Major vascular complications
Time frame: In-hospital through discharge, up to 15 days
Stroke
Time frame: In-hospital through discharge, up to 15 days
Worsening Aortic Regurgitation
Time frame: In-hospital through discharge, up to 15 days
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