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

Overview

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.

Interventions

• Device Impella
  US commercially approved Impella CP is the device that study inclusion will be based on. Only patients with AMICS who receive Impella CP as the first Impella device after cardiogenic shock onset will be included in the study.

Primary outcome measures

• Composite Safety [Time frame: All in-hospital events through discharge, an average of 15 days]

Secondary outcome measures (12)

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [Time frame: Up to 1 year post-Impella implant]
• All-cause mortality [Time frame: Up to 1 year post-Impella implant]
• Cardiovascular death [Time frame: Up to 1 year post-Impella implant]
• Cardiovascular hospitalizations [Time frame: Up to 1 year post-Impella implant]
• Heart failure hospitalizations [Time frame: Up to 1 year post-Impella implant]
• Heart transplant or durable LVAD implantation [Time frame: Up to 1 year post-Impella implant]
• Any new renal replacement therapy (RRT) [Time frame: Up to 1 year post-Impella implant]
• Acute kidney injury (AKI) [Time frame: In-hospital through discharge, up to 15 days]
• Major bleeding [Time frame: In-hospital through discharge, up to 15 days]
• Hemolysis [Time frame: In-hospital through discharge, up to 15 days]
• Acute limb ischemia (ALI) [Time frame: In-hospital through discharge, up to 15 days]
• Major vascular complications [Time frame: In-hospital through discharge, up to 15 days]

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), STEMI equivalents, or new or presumed new left bundle branch block 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 confirmed by at least two of the following:

• Tissue hypoperfusion, manifested by an arterial or venous blood lactate level ≥2.5 mmol/L or SvO2 <55% in the presence of a PaO2 > 90mmHg
• 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/m\^2 or a cardiac power output ≤0.6 W
• 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
• <12 hours after initiating primary PCI
• Patient was supported with Impella CP as the initial MCS device for cardiogenic shock
• Age ≥18 years
• Europe only: Subject or legally designated representative (LDR) or Independent Physician has provided written informed consent for participation in the observational study

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).
• 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, including acute bradyarrhythmias, tachyarrhythmias, or advanced heart block
• 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
• Procedural complication of the PCI that results in coronary perforation
• 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 are excluded if: They were not following verbal commands immediately prior to intubation, or They were not clearly following verbal commands after intubation within 6 hours post-PCI
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 18 centers

• Cardiology Associates Research Group (St. Bernard's Hospital) — Jonesboro
• St. Joseph Hospital Orange — Orange
• Torrance Memorial Medical Center — Torrance
• NCH Rooney Heart Institute — Naples
• Straub Benioff Medical Center — Honolulu
• OSF Saint Francis — Peoria
• Brigham and Women's Hospital — Boston
• Henry Ford Health System — Detroit
• … and 10 more centers

Publications

• Kapur NK, Kanwar M, Sinha SS, Thayer KL, Garan AR, Hernandez-Montfort J, Zhang Y, Li B, Baca P, Dieng F, Harwani NM, Abraham J, Hickey G, Nathan S, Wencker D, Hall S, Schwartzman A, Khalife W, Li S, Mahr C, Kim JH, Vorovich E, Whitehead EH, Blumer V, Burkhoff D. Criteria for Defining Stages of Cardiogenic Shock Severity. J Am Coll Cardiol. 2022 Jul 19;80(3):185-198. doi: 10.1016/j.jacc.2022.04.049 PMID 35835491
• Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR; Peer Review Committee Members. 2024 ACC/AHA/AACVPR/APMA/ PMID 38743805
• Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4. PMID 9308598
• 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 Inte PMID 23894025
• 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 1 PMID 30571511

Identifiers

NCT: NCT06964685 · ABMD-CIP-2024-04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗