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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

Tracking Information
First Submitted Date August 17, 2018
First Posted Date September 19, 2018
Last Update Posted Date August 7, 2019
Actual Study Start Date May 1, 2016
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2018)
Survival to discharge from hospital [ Time Frame: Hospital discharge (average= 11 days) ]
All cause mortality at hospital discharge.
Original Primary Outcome Measures
 (submitted: September 17, 2018)
Survival to discharge from hospital [ Time Frame: Hospital discharge (average= 11 days) ]
All cause mortality at hospital discharge
Change History Complete list of historical versions of study NCT03677180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 11, 2018)
  • 30 Day Mortality [ Time Frame: 30 days ]
    All cause mortality at 30 days post-discharge.
  • 1 Year Mortality [ Time Frame: 1 year ]
    All cause mortality at 1 year post-discharge
Original Secondary Outcome Measures
 (submitted: September 17, 2018)
  • 30 Day Mortality [ Time Frame: 30 days ]
    All cause mortality at 30 days post-discharge
  • 1 Year Mortality [ Time Frame: 1 year ]
    All cause mortality at 1 year post-discharge
Current Other Pre-specified Outcome Measures
 (submitted: December 11, 2018)
  • 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).
  • 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.
  • 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.
  • 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).
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title National Cardiogenic Shock Initiative
Official Title National Cardiogenic Shock Initiative
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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients presenting with acute myocardial infarction and cardiogenic shock treated with mechanical circulatory support.
Condition
  • Cardiogenic Shock
  • Acute Myocardial Infarction
  • STEMI - ST Elevation Myocardial Infarction
  • NSTEMI - Non-ST Segment Elevation MI
  • Heart Attack
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 17, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Babar Basir, DO 313-916-8708 NationalCSI@hfhs.org
Contact: Michael Hacala 313-916-8708 NationalCSI@hfhs.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03677180
Other Study ID Numbers NCSI
National CSI ( Other Identifier: Henry Ford Health System )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party William W. O'Neill, Henry Ford Health System
Study Sponsor Henry Ford Health System
Collaborators
  • Abiomed Inc.
  • Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: William W O'Neill, MD Henry Ford Health System
Study Director: Babar Basir, DO Henry Ford Health System
PRS Account Henry Ford Health System
Verification Date August 2019