Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock

NCT06964685 | Recruiting FDA Device

• 1 other identifier: ABMD-CIP-2024-04
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 10

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 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

AMI Cardiogenic Shock

Outcome Measures

Primary Outcomes (1)

• Composite Safety

  Composite safety endpoint (major bleeding, acute limb ischemia, or acute kidney injury requiring renal replacement therapy)

  All in-hospital events through discharge, an average of 15 days

Secondary Outcomes (14)

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

  Up to 1 year post-Impella implant

• All-cause mortality

  Up to 1 year post-Impella implant

• Cardiovascular death

  Up to 1 year post-Impella implant

• Cardiovascular hospitalizations

  Up to 1 year post-Impella implant

• Heart failure hospitalizations

  Up to 1 year post-Impella implant

Interventions

Impella DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• Peripheral signs of tissue hypoperfusion (arterial or venous 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/m\^2 or a cardiac power output ≤0.6 W
• Cardiogenic shock that develops under one of the following conditions:
• a. prior to primary PCI, with \<24 hours from the onset of shock to cath lab arrival, or
• b. b. \<12 hours after initiating primary PCI
• Patient was supported with Impella CP as the initial MCS device for cardiogenic shock
• Age ≥18 years

You may not qualify if:

• 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
• 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 are excluded if:
• They were not following verbal commands immediately prior to intubation, or
• They were not clearly following verbal commands after intubation
• Infective endocarditis

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (10)

Cardiology Associates Research Group (St. Bernard's Hospital)

Jonesboro, Arkansas, 72401, United States

RECRUITING

St. Joseph Hospital Orange

Orange, California, 92868, United States

RECRUITING

NCH Rooney Heart Institute

Naples, Florida, 34102, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

New Mexico Heart

Albuquerque, New Mexico, 87102, United States

RECRUITING

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

RECRUITING

St. Francis

Tulsa, Oklahoma, 74136, United States

RECRUITING

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

RECRUITING

Parkwest Medical Center

Knoxville, Tennessee, 37923, United States

RECRUITING

Method Hospital

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jun 11;149(24):e1313-e1410. doi: 10.1161/CIR.0000000000001251. Epub 2024 May 14.

  PMID: 38743805 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 23894025 BACKGROUND

• 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.

  PMID: 30571511 BACKGROUND

Central Study Contacts

Sameera Dasari, PhD

CONTACT

978-914-8882; sdasar12@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 9, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (10)