Condition: AMI Cardiogenic Shock · Sponsor: Abiomed Inc.
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 el…
This description comes directly from the study's public registry record.
Sameera Dasari, PhD · 978-914-8882 · sdasar12@its.jnj.com
Always discuss trial participation with your own doctor first.
| Cardiology Associates Research Group (St. Bernard's Hospital) | Jonesboro, Arkansas, United States | Recruiting |
| St. Joseph Hospital Orange | Orange, California, United States | Recruiting |
| Torrance Memorial Medical Center | Torrance, California, United States | Recruiting |
| NCH Rooney Heart Institute | Naples, Florida, United States | Recruiting |
| Straub Benioff Medical Center | Honolulu, Hawaii, United States | Recruiting |
| OSF Saint Francis | Peoria, Illinois, United States | Recruiting |
| Brigham and Women's Hospital | Boston, Massachusetts, United States | Recruiting |
| Henry Ford Health System | Detroit, Michigan, United States | Recruiting |
| New Mexico Heart | Albuquerque, New Mexico, United States | Recruiting |
| Bethesda North Hospital | Cincinnati, Ohio, United States | Recruiting |
| Saint Francis Hospital | Tulsa, Oklahoma, United States | Recruiting |
| Providence St. Vincent Medical Center | Portland, Oregon, United States | Recruiting |
+ 6 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06964685