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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Cardiology Associates Research Group (St. Bernard's Hospital)
  Jonesboro, Arkansas, United States Recruiting
• St. Joseph Hospital Orange
  Orange, California, United States Recruiting
• Torrance Memorial Medical Center
  Torrance, California, United States Recruiting
• NCH Rooney Heart Institute
  Naples, Florida, United States Recruiting
• Straub Benioff Medical Center
  Honolulu, Hawaii, United States Recruiting
• OSF Saint Francis
  Peoria, Illinois, United States Recruiting

Study contacts

• Study coordinator: Sameera Dasari, PhD
• Email: sdasar12@its.jnj.com
• Phone: 978-914-8882

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Factors Influencing Outcomes in ECMO and Impella Patients

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  Recruiting Gottsegen National Cardiovascular Institute · Budapest · NCT07885618

• Evaluating a noninvasive tissue sensor to detect cardiogenic shock earlier in heart patients

  This pilot, noninvasive study tests whether the NIRSense wearable can help detect deterioration in adults with cardiogenic shock risk due to heart attack or heart failure.

  Recruiting NIRSense Inc. · Weston, Florida · NCT07825363

• Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock

  This study tests whether an extracorporeal ventricular assist device can safely provide short-term heart support and help patients with cardiogenic shock or trouble weaning from bypass.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07769528

• Left Ventricular Support and Advanced Monitoring in AMI–Cardiogenic Shock: Immediate Impella Use and PAC/Monitoring vs Standard Care

  In adults with heart attack-related cardiogenic shock, this trial tests whether using an Impella left ventricular assist device and/or protocolized pulmonary artery catheter monitoring improves survival compared with standard care.

  Recruiting Leipzig Heart Science gGmbH · Leipzig, Saxony · NCT07762560

• CRP Apheresis for infarct-related cardiogenic shock

  This study tests whether selectively removing C-reactive protein with apheresis, in addition to standard care, helps people with cardiogenic shock after a heart attack.

  Recruiting Leipzig Heart Science gGmbH · Leipzig, Saxony · NCT07687017

• Compare two ventilator modes in adults with cardiac ICU needs and invasive ventilation

  This pilot tests whether volume-controlled versus pressure-controlled ventilation can be safely used in adults with heart disease and respiratory failure who need invasive ventilation.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07656259

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.