National Cardiogenic Shock Initiative
- Conditions
- Heart AttackCardiogenic ShockNSTEMI - Non-ST Segment Elevation MISTEMI - ST Elevation Myocardial InfarctionAcute Myocardial Infarction
- Registration Number
- NCT03677180
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 406
-
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)
-
Cardiogenic shock is defined as the presence of at least two of the following:
- Hypotension (systolic blood pressure ≤90 mm Hg, or inotropes/vasopressors to maintain systolic blood pressure ≥90 mmHg)
- Signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or elevated lactate levels)
- Hemodynamic criteria represented by a cardiac index of <2.2 L/min/m2 or a cardiac power output ≤0.6 watts.
-
Patient is supported with an Impella
-
Patient undergoes PCI
Registry
- Evidence of Anoxic Brain Injury
- Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes
- IABP placed prior to Impella
- Septic, anaphylactic, hemorrhagic, and neurologic causes of shock
- Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
- Active bleeding for which mechanical circulatory support is contraindicated
- Recent major surgery for which mechanical circulatory support is contraindicated
- Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
- Known left ventricular thrombus for which mechanical circulatory support is contraindicated
- Mechanical aortic prosthetic valve
- Contraindication to intravenous systemic anticoagulation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival to discharge from hospital Hospital discharge (average= 11 days) All cause mortality at hospital discharge.
- Secondary Outcome Measures
Name Time Method 1 Year Mortality 1 year All cause mortality at 1 year post-discharge
30 Day Mortality 30 days All cause mortality at 30 days post-discharge.
Trial Locations
- Locations (75)
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
St. Joseph Hospital Orange
🇺🇸Orange, California, United States
Overland Park Regional Medical Center
🇺🇸Overland Park, Kansas, United States
UCLA Medical Center, Santa Monica
🇺🇸Santa Monica, California, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
George Washington University Hospital
🇺🇸Washington, District of Columbia, United States
Elmhurst Hospital
🇺🇸Elmhurst, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
UAB Hospital
🇺🇸Birmingham, Alabama, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Hackensack Meridian Health Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Presbyterian Hospital
🇺🇸Albuquerque, New Mexico, United States
Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
Spectrum Health Fred and Lena Meijer Heart Center
🇺🇸Grand Rapids, Michigan, United States
Henry Ford Macomb Hospital
🇺🇸Clinton Township, Michigan, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Physicians Regional Medical Center
🇺🇸Knoxville, Tennessee, United States
Buffalo General Medical Center
🇺🇸Buffalo, New York, United States
Beaumont Hospital, Royal Oak
🇺🇸Royal Oak, Michigan, United States
Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
North Knoxville Medical Center
🇺🇸Knoxville, Tennessee, United States
Fort Sanders Regional Medical Center
🇺🇸Knoxville, Tennessee, United States
Methodist Medical Center
🇺🇸Oak Ridge, Tennessee, United States
San Juan Regional Medical Center
🇺🇸Farmington, New Mexico, United States
Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Parkwest Regional Medical Center
🇺🇸Knoxville, Tennessee, United States
Carilion Roanoke Memorial Hospital
🇺🇸Roanoke, Virginia, United States
St. Anthony Hospital
🇺🇸Lakewood, Colorado, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Northwest Medical Center - Springdale
🇺🇸Springdale, Arkansas, United States
Palmetto General Hospital
🇺🇸Hialeah, Florida, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Orange Park Medical Center
🇺🇸Jacksonville, Florida, United States
SSM Health St. Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital of Buffalo
🇺🇸Buffalo, New York, United States
PeaceHealth Sacred Heart Medical Center at Riverbend
🇺🇸Springfield, Oregon, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
DMC Heart Hospital
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Brooke Army Medical Center
🇺🇸San Antonio, Texas, United States
TriStar Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Methodist Hospital
🇺🇸San Antonio, Texas, United States
Edward Hospital
🇺🇸Naperville, Illinois, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Mercy Fitzgerald Hospital
🇺🇸Darby, Pennsylvania, United States
Excela Westmoreland Regional Hospital
🇺🇸Greensburg, Pennsylvania, United States
Texas Health Presbyterian Hospital Dallas
🇺🇸Dallas, Texas, United States
UVA University Hospital
🇺🇸Charlottesville, Virginia, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
CHI Health Nebraska Heart
🇺🇸Lincoln, Nebraska, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
St. Joseph Mercy Oakland Hospital
🇺🇸Pontiac, Michigan, United States
Beaumont Hospital, Troy
🇺🇸Troy, Michigan, United States
Washington Regional Medical Center
🇺🇸Fayetteville, Arkansas, United States
Englewood Hospital
🇺🇸Englewood, New Jersey, United States
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
KentuckyOne Health Saint Joseph Hospital
🇺🇸Lexington, Kentucky, United States
Iowa Heart Center at Mercy Medical Center
🇺🇸Des Moines, Iowa, United States
KentuckyOne Health Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States