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National Cardiogenic Shock Initiative (NCSI)

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ClinicalTrials.gov Identifier: NCT03677180
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Abiomed Inc.
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
William W. O'Neill, Henry Ford Health System

Brief 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.

Condition or disease
Cardiogenic Shock Acute Myocardial Infarction STEMI - ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI Heart Attack

Detailed 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: National Cardiogenic Shock Initiative
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock




Primary Outcome Measures :
  1. Survival to discharge from hospital [ Time Frame: Hospital discharge (average= 11 days) ]
    All cause mortality at hospital discharge.


Secondary Outcome Measures :
  1. 30 Day Mortality [ Time Frame: 30 days ]
    All cause mortality at 30 days post-discharge.

  2. 1 Year Mortality [ Time Frame: 1 year ]
    All cause mortality at 1 year post-discharge


Other Outcome Measures:
  1. Use of MCS Pre-PCI [ Time Frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention) ]
    Number of patients who receive mechanical circulatory support (MCS) pre-PCI (percutaneous coronary intervention).

  2. Door to Support Time < 90 Minutes [ Time Frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention) ]
    Time from patient presentation at hospital to time that MCS (mechanical circulatory support) was started.

  3. Establish TIMI III Flow [ Time Frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention) ]
    Establishment of TIMI III (thrombolysis in myocardial infarction) coronary blood flow during index PCI (percutaneous coronary intervention) in culprit lesions.

  4. Wean off Vasopressors & Inotropes [ Time Frame: At index PCI (percutaneous coronary intervention), 12-hours post-PCI, 24-hours post-PCI ]
    Ability to wean off vasopressor & inotropic medication use in patients being treated with early MCS (mechanical circulatory support) during treatment for AMICS (acute myocardial infarction with cardiogenic shock).

  5. Maintain CPO >0.6 Watts [ Time Frame: At index PCI (percutaneous coronary intervention), 12-hours post-PCI, 24-hours post-PCI ]
    Ability to maintain a cardiac power output (CPO) measurement of > 0.6 watts.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients presenting with acute myocardial infarction and cardiogenic shock treated with mechanical circulatory support.
Criteria

Registry Inclusion Criteria:

  1. Symptoms of acute myocardial infarction (AMI) with ECG and/or biomarker evidence of S-T elevation myocardial infarction (STEMI) or non-S-T elevation myocardial infarction (NSTEMI)
  2. Cardiogenic shock is defined as the presence of at least two of the following:

    1. Hypotension (systolic blood pressure ≤90 mm Hg, or inotropes/vasopressors to maintain systolic blood pressure ≥90 mmHg)
    2. Signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or elevated lactate levels)
    3. Hemodynamic criteria represented by a cardiac index of <2.2 L/min/m2 or a cardiac power output ≤0.6 watts.
  3. Patient is supported with an Impella
  4. Patient undergoes PCI

Registry Exclusion Criteria:

  1. Evidence of Anoxic Brain Injury
  2. Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes
  3. IABP placed prior to Impella
  4. Septic, anaphylactic, hemorrhagic, and neurologic causes of shock
  5. Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
  6. Active bleeding for which mechanical circulatory support is contraindicated
  7. Recent major surgery for which mechanical circulatory support is contraindicated
  8. Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
  9. Known left ventricular thrombus for which mechanical circulatory support is contraindicated
  10. Mechanical aortic prosthetic valve
  11. Contraindication to intravenous systemic anticoagulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677180


Contacts
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Contact: Babar Basir, DO 313-916-8708 NationalCSI@hfhs.org
Contact: Michael Hacala 313-916-8708 NationalCSI@hfhs.org

  Show 91 Study Locations
Sponsors and Collaborators
Henry Ford Health System
Abiomed Inc.
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: William W O'Neill, MD Henry Ford Health System
Study Director: Babar Basir, DO Henry Ford Health System
  Study Documents (Full-Text)

Documents provided by William W. O'Neill, Henry Ford Health System:
Study Protocol  [PDF] July 31, 2018


Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: William W. O'Neill, Medical Director, Center for Structural Heart Disease, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03677180     History of Changes
Other Study ID Numbers: NCSI
National CSI ( Other Identifier: Henry Ford Health System )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William W. O'Neill, Henry Ford Health System:
Cardiogenic shock
Mechanical circulatory support
National Cardiogenic Shock Initiative
Myocardial infarction
Heart attack
Acute MI
NCSI
National CSI
Impella
Shock
Hemodynamic Support
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Shock, Cardiogenic
Infarction
Shock
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases