Impella CP with best-practice care during PCI for heart attack with cardiogenic shock

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

This project will see if using Impella CP with specified best-practice management during PCI is safe for people who have a heart attack complicated by cardiogenic shock.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abiomed Inc. (Industry-sponsored)
• Locations: 10 sites (Jonesboro, Arkansas and 9 other locations)
• Trial ID: NCT06964685 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter observational registry enrolling up to 350 hemodynamically unstable patients with acute myocardial infarction complicated by cardiogenic shock who receive an Impella CP during PCI. Cardiogenic shock is confirmed by tissue hypoperfusion (for example, lactate ≥2.5 mmol/L or SvO2 <55%) together with low systolic blood pressure or the need for vasopressors. Participants are managed using predefined Impella best-practice protocols alongside guideline-directed medical therapy, and the study collects predefined safety endpoints including composite adverse events. As an observational cohort, there is no randomized comparison; investigators will describe real-world practice patterns and safety outcomes across participating centers.

Who should consider this trial

Good fit: Adults with a recent acute myocardial infarction complicated by cardiogenic shock who receive Impella CP during PCI and meet hemodynamic and perfusion criteria (for example, lactate ≥2.5 mmol/L or SvO2 <55% and low systolic blood pressure or need for vasopressors) are the intended participants.

Not a fit: People who are hemodynamically stable, have chronic or late-presenting shock outside the specified time windows, or who do not receive an Impella CP during PCI are unlikely to benefit directly from this study's findings.

Why it matters

Potential benefit: If successful, this could clarify safer ways to use Impella CP in heart attack patients with cardiogenic shock and help reduce device-related complications.

How similar studies have performed: Prior observational registries and single-center series have reported mixed safety and outcome signals for Impella in cardiogenic shock, while randomized data remain limited.

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:

  * 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

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 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
* 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

Where this trial is running

Jonesboro, Arkansas and 9 other locations

• Cardiology Associates Research Group (St. Bernard's Hospital) — Jonesboro, Arkansas, United States (Recruiting)
• St. Joseph Hospital Orange — Orange, California, United States (Recruiting)
• NCH Rooney Heart Institute — Naples, Florida, United States (Recruiting)
• Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
• New Mexico Heart — Albuquerque, New Mexico, United States (Recruiting)
• Bethesda North Hospital — Cincinnati, Ohio, United States (Recruiting)
• St. Francis — Tulsa, Oklahoma, United States (Recruiting)
• Providence St. Vincent Medical Center — Portland, Oregon, United States (Recruiting)
• Parkwest Medical Center — Knoxville, Tennessee, United States (Recruiting)
• Method Hospital — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Sameera Dasari, PhD

Conditions AMI Cardiogenic Shock