Actively Recruiting
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Led by Abiomed Inc. · Updated on 2026-03-20
350
Participants Needed
10
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute myocardial infarction (AMI) of less than 36 hours duration from symptom onset to cath lab arrival, confirmed by ECG and/or biomarker evidence of STEMI, STEMI equivalents, new or presumed new left bundle branch block, or NSTEMI with angiographic evidence of culprit vessels
- Cardiogenic shock confirmed by at least two of the following: tissue hypoperfusion (blood lactate 2.5 mmol/l or SvO2 <55% with normal PaO2), systolic blood pressure <100 mmHg or need for vasoactive agents, or cardiac index <2.2 L/min/m or cardiac power output 0.6 W
- Cardiogenic shock developing prior to primary PCI with less than 24 hours from shock onset to cath lab arrival or less than 12 hours after starting primary PCI
- Patient supported with Impella CP as the initial mechanical circulatory support device for cardiogenic shock
- Age 18 years or older
You will not qualify if you...
- Any contraindication listed in the Impella CP instructions for use, including mural thrombus in left ventricle, mechanical aortic valve or heart constrictive device, severe aortic valve stenosis or insufficiency, severe arterial disease preventing Impella placement, atrial or ventricular septal defect, significant right heart failure, left ventricular rupture, cardiac tamponade, or combined cardiorespiratory failure
- Shock mainly due to causes other than left ventricular failure such as right ventricular infarction, hypovolemia, anaphylaxis, hemorrhage, sepsis, myocarditis, pulmonary embolism, pneumothorax, or high cardiac output shock
- Severe arrhythmias as the primary cause of low cardiac output
- Known mechanical complications of AMI causing cardiogenic shock such as free wall rupture, ventricular septal defect, or papillary muscle rupture with acute mitral regurgitation
- Other mechanical circulatory support devices already in place or Impella CP placed before transfer to cath lab
- Acute or chronic aortic dissection
- Prior PCI at another institution for the present infarction
- Thrombolytic therapy for the present infarction
- Not following verbal commands after cardiac arrest indicating possible brain injury; intubated subjects not following commands before or after intubation
- Infective endocarditis
- Severe other diseases with life expectancy less than 1 year (excluding cardiogenic shock)
- Participation in another active clinical study of an investigational drug or device that has not reached its primary endpoint
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Cardiology Associates Research Group (St. Bernard's Hospital)
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
St. Joseph Hospital Orange
Orange, California, United States, 92868
Actively Recruiting
3
NCH Rooney Heart Institute
Naples, Florida, United States, 34102
Actively Recruiting
4
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
5
New Mexico Heart
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
6
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Actively Recruiting
7
St. Francis
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
8
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
9
Parkwest Medical Center
Knoxville, Tennessee, United States, 37923
Actively Recruiting
10
Method Hospital
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
S
Sameera Dasari, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here