Clinical trial NCT06964685: Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Official title: Observational Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: AMI Cardiogenic Shock
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only patients with AMICS who receive Impella CP as the first Impella device after cardiogenic shock onset will be included in the study.

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Composite Safety
timeFrame: All in-hospital events through discharge, an average of 15 days
Secondary outcomes:
measure: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: Up to 1 year post-Impella implant
measure: All-cause mortality
timeFrame: Up to 1 year post-Impella implant
measure: Cardiovascular death
timeFrame: Up to 1 year post-Impella implant
measure: Cardiovascular hospitalizations
timeFrame: Up to 1 year post-Impella implant
measure: Heart failure hospitalizations
timeFrame: Up to 1 year post-Impella implant
measure: Heart transplant or durable LVAD implantation
timeFrame: Up to 1 year post-Impella implant
measure: Any new renal replacement therapy (RRT)
timeFrame: Up to 1 year post-Impella implant
measure: Acute kidney injury (AKI)
timeFrame: In-hospital through discharge, up to 15 days
measure: Major bleeding
timeFrame: In-hospital through discharge, up to 15 days
measure: Hemolysis
timeFrame: In-hospital through discharge, up to 15 days
measure: Acute limb ischemia (ALI)
timeFrame: In-hospital through discharge, up to 15 days
measure: Major vascular complications
timeFrame: In-hospital through discharge, up to 15 days
measure: Stroke
timeFrame: In-hospital through discharge, up to 15 days
measure: Worsening Aortic Regurgitation
timeFrame: In-hospital through discharge, up to 15 days
Other outcomes:
Locations:
city: Orange
country: United States
facility: St. Joseph Hospital Orange
state: California
city: Wichita
country: United States
facility: Ascension via Christi
state: Kansas
city: Albuquerque
country: United States
facility: New Mexico Heart
state: New Mexico
Study officials:
References:
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citation: Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW; Society for Cardiovascular Angiography and Interventions. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). Catheter Cardiovasc Interv. 2014 Jan 1;83(1):27-36. doi: 10.1002/ccd.25135. Epub 2013 Oct 16.
citation: Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.