National Cardiogenic Shock Initiative

  • STATUS
    Not Recruiting
  • End date
    May 17, 2022
  • participants needed
    500
  • sponsor
    Henry Ford Health System
Updated on 2 February 2021
Investigator
Babar Basir, DO
Primary Contact
Hackensack Meridian Health Jersey Shore University Medical Center (2.2 mi away) Contact
+92 other location
hypoperfusion
systolic blood pressure
myocardial infarction
stemi
infarct
inotropes
mechanical circulatory support
vasopressor
oliguria
early identification
vasopressors
acute myocardial infarction
inotropic agent

Summary

This study evaluates the use of early mechanical circulatory support in patients presenting with acute myocardial infarction and cardiogenic shock. Patients are treated according to the National Cardiogenic Shock Initiative protocol, which emphasizes early identification of cardiogenic shock and rapid delivery of mechanical circulatory support based on invasive hemodynamics. All patients treated in this manner are enrolled in the National Cardiogenic Shock registry.

Description

Acute myocardial infarction complicated by cardiogenic shock (AMICS) is a deadly condition with a historical in-hospital survival of only 50%. To date, the only therapy proven to benefit patients in AMICS using data from randomized control trials has been early mechanical reperfusion. Accordingly, current American and European guidelines confer a class IB indication for reperfusion therapy in the setting of AMICS. Unfortunately, little progress has been made on improving survival with subsequent therapies, including intra-aortic balloon pump counter-pulsation (IABP). This lack of progress is worrisome since the incidence of AMICS appears to be increasing.

With the FDA approval of Impella (Abiomed, Danvers, MA) in AMICS, a powerful new tool has become available for hemodynamic support. Impella is a transcatheter axial flow pump, delivered percutaneous, with the ability to provide 2.5 to 4.0 liters/minute of forward flow. The device should provide sufficient forward cardiac flow to support vital organs in the majority of patients who present with AMICS. Since Impella is the only percutaneous temporary ventricular support device approved as safe and effective for use in AMICS, the use of the device has steadily grown. Unfortunately, there is little data available to providers as to the best practice patterns associated with the delivery and use of Impella in AMICS.

Using the most up-to-date research, a treatment algorithm for AMICS was developed and subsequently implemented as a quality improvement initiative throughout southeast Michigan. Patient information was gathered by each of the sites and collected in a retrospective registry. Outcomes and results were shared during quarterly meetings and concluded with a 41-patient pilot feasibility study. This initial pilot study revealed a 76% survival to discharge, a significant improvement compared to prior historical controls.

Given the promising outcomes, leaders from around the world have implemented the treatment algorithm in their local clinical practices with similar results. The investigators have therefore launched the National Cardiogenic Shock Initiative (NCSI). The aim of the NCSI is to bring together experienced centers across the nation who are experts in mechanical reperfusion therapies and have a large experience with the use of mechanical circulatory support devices to systematize care in AMICS.

Our goal is to dramatically decrease the duration patients remain in cardiogenic shock and attempt to decrease total usage and duration of vasopressors and ionotropic agents. The investigators aim to further demonstrate that rapid delivery of mechanical circulatory support will improve hemodynamics, reverse the spiraling neuro-hormonal cascade associated with cardiogenic shock, allowing clinicians to decrease use of vasopressors and inotropic agents and ultimately improve survival.

Healthcare systems that have agreed to adopt the NCSI treatment algorithm are being asked to participate in this prospective registry so that patient outcomes can be analyzed. Participating investigators will be asked to voluntarily provide data from patients completing the treatment algorithm to be included in the NCSI Registry.

Details
Condition Myocardial Infarction, Cardiogenic shock, Ischemic Heart Disease, Heart Attack (Myocardial Infarction), Acute Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, Cardiac Ischemia, Myocardial Ischemia, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, heart attack, myocardial infarction (mi), cardiac infarction, heart attacks, myocardial necrosis, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI
Clinical Study IdentifierNCT03677180
SponsorHenry Ford Health System
Last Modified on2 February 2021

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