Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Start Date
7/10/2025
Completion Date
10/30/2028
Summary
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 350 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Impella
Conditions
Locations
Cardiology Associates Research Group (St. Bernard's Hospital)
Jonesboro, Arkansas 72401
United States
St. Joseph Hospital Orange
Orange, California 92868
United States
Torrance Memorial Medical Center
Torrance, California 90505
United States
NCH Rooney Heart Institute
Naples, Florida 34102
United States
Straub Benioff Medical Center
Honolulu, Hawaii 96813
United States
OSF Saint Francis
Peoria, Illinois 61637
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
New Mexico Heart
Albuquerque, New Mexico 87102
United States
Bethesda North Hospital
Cincinnati, Ohio 45242
United States
Saint Francis Hospital
Tulsa, Oklahoma 74136
United States
Providence St. Vincent Medical Center
Portland, Oregon 97225
United States
Legacy Emanuel Medical Center
Portland, Oregon 97227
United States
Parkwest Medical Center
Knoxville, Tennessee 37923
United States
Texas Health Presbyterian Hospital Dallas
Dallas, Texas 75231
United States
UTHealth Memorial Hermann
Houston, Texas 77030
United States
Methodist Hospital
San Antonio, Texas 78229
United States
Inova Fairfax
Falls Church, Virginia 22042
United States