Status:
RECRUITING
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Lead Sponsor:
Abiomed Inc.
Conditions:
AMI Cardiogenic Shock
Eligibility:
All Genders
18+ years
Brief 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 safe...
Eligibility Criteria
Inclusion
- Acute myocardial infarction (AMI) of \<36 hours duration from symptom onset to cath lab arrival, confirmed by:
- ECG and/or biomarker evidence of ST-segment elevation myocardial infarction (STEMI) or
- ECG and/or biomarker evidence of non-ST-segment elevation myocardial infarction (NSTEMI) and angiographic evidence of one or more culprit vessels
- Cardiogenic shock that develops under one of the following conditions: prior to primary PCI, with \<24 hours from the onset of shock to cath lab arrival, or within 12 hours after initiating primary PCI. Cardiogenic shock is confirmed by at least two of the following:
- Peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5 mmol/l or SvO2 \<55% with a normal PaO2)
- Systolic blood pressure \<100 mmHg or need for vasoactive agents to maintain systolic blood pressure ≥100 mmHg
- Hemodynamic criteria represented by a cardiac index of \<2.2 L/min/m2 or a cardiac power output ≤0.6 W
- Patient received PCI to treat the AMI
- Patient was supported with Impella CP as the initial MCS device for cardiogenic shock
- Age ≥18 years
Exclusion
- Any contraindication listed in the Impella CP IFU if known to be present (i.e. mural thrombus in the left ventricle; presence of a mechanical aortic valve or heart constrictive device; aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); severe arterial disease precluding placement of the Impella system; presence of an atrial or ventricular septal defect (including post-infarct VSD); significant right heart failure; left ventricular rupture; cardiac tamponade; combined cardiorespiratory failure).
- 2\. Shock principally due to a cause other than LV failure, including:
- RV 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 that may cause cardiogenic shock such as free wall rupture, ventricular septal defect or papillary muscle rupture with acute mitral regurgitation
- Other mechanical circulatory support already in place for present indication, including intra-aortic balloon counter-pulsation or patients with Impella CP placement prior to transfer to the cath lab at the tertiary facility
- Acute or chronic aortic dissection
- Prior PCI at another institution for the present infarction
- Thrombolytic therapy for the present infarction
- Not obeying verbal commands after preadmission or in-hospital cardiac arrest, indicative of possible anoxic brain injury NOTE:
- Non-intubated subjects: A positive and appropriate response to commands must be repeatable on at least two (2) instances to rule out reflex response to voice
- Intubated subjects: May be included if:
- They were following verbal commands immediately prior to intubation, or
- They were clearly following verbal commands after intubation
- Infective endocarditis
- Other severe, concomitant disease with limited life expectancy \<1 year (other than cardiogenic shock)
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached the timing of its primary endpoint
Key Trial Info
Start Date :
July 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06964685
Start Date
July 10 2025
End Date
October 30 2028
Last Update
September 4 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Joseph Hospital Orange
Orange, California, United States, 92868
2
Ascension via Christi
Wichita, Kansas, United States, 67226
3
New Mexico Heart
Albuquerque, New Mexico, United States, 87102