National Cardiogenic Shock Initiative

Acute Myocardial Infarction Clinical Trial

— NCSI  

Official title:

National Cardiogenic Shock Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677180
• Other study ID #: NCSI
• Secondary ID: National CSI
• Status: Completed
• Start date: May 19, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: December 31, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiogenic Shock
• Heart Attack
• Infarction
• Myocardial Infarction
• NSTEMI - Non-ST Segment Elevation MI
• Shock
• Shock, Cardiogenic
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
United States	Presbyterian Hospital	Albuquerque	New Mexico
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Heart Hospital of Austin	Austin	Texas
United States	UAB Hospital	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Buffalo General Medical Center	Buffalo	New York
United States	Mercy Hospital of Buffalo	Buffalo	New York
United States	UVA University Hospital	Charlottesville	Virginia
United States	The Christ Hospital	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Henry Ford Macomb Hospital	Clinton Township	Michigan
United States	Texas Health Presbyterian Hospital Dallas	Dallas	Texas
United States	Mercy Fitzgerald Hospital	Darby	Pennsylvania
United States	Iowa Heart Center at Mercy Medical Center	Des Moines	Iowa
United States	Ascension St. John Hospital	Detroit	Michigan
United States	DMC Heart Hospital	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Elmhurst Hospital	Elmhurst	Illinois
United States	Englewood Hospital	Englewood	New Jersey
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	San Juan Regional Medical Center	Farmington	New Mexico
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	North Florida Regional Medical Center	Gainesville	Florida
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Spectrum Health Fred and Lena Meijer Heart Center	Grand Rapids	Michigan
United States	Excela Westmoreland Regional Hospital	Greensburg	Pennsylvania
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Palmetto General Hospital	Hialeah	Florida
United States	Orange Park Medical Center	Jacksonville	Florida
United States	Research Medical Center	Kansas City	Missouri
United States	Kettering Medical Center	Kettering	Ohio
United States	Fort Sanders Regional Medical Center	Knoxville	Tennessee
United States	North Knoxville Medical Center	Knoxville	Tennessee
United States	Parkwest Regional Medical Center	Knoxville	Tennessee
United States	Physicians Regional Medical Center	Knoxville	Tennessee
United States	Turkey Creek Medical Center	Knoxville	Tennessee
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	St. Anthony Hospital	Lakewood	Colorado
United States	KentuckyOne Health Saint Joseph Hospital	Lexington	Kentucky
United States	CHI Health Nebraska Heart	Lincoln	Nebraska
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	KentuckyOne Health Jewish Hospital	Louisville	Kentucky
United States	Methodist University Hospital	Memphis	Tennessee
United States	Edward Hospital	Naperville	Illinois
United States	TriStar Centennial Medical Center	Nashville	Tennessee
United States	Hackensack Meridian Health Jersey Shore University Medical Center	Neptune	New Jersey
United States	Methodist Medical Center	Oak Ridge	Tennessee
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	St. Joseph Hospital Orange	Orange	California
United States	Overland Park Regional Medical Center	Overland Park	Kansas
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	St. Joseph Mercy Oakland Hospital	Pontiac	Michigan
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Beaumont Hospital, Royal Oak	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	SSM Health St. Louis University Hospital	Saint Louis	Missouri
United States	Brooke Army Medical Center	San Antonio	Texas
United States	Methodist Hospital	San Antonio	Texas
United States	UCLA Medical Center, Santa Monica	Santa Monica	California
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	Northwest Medical Center - Springdale	Springdale	Arkansas
United States	PeaceHealth Sacred Heart Medical Center at Riverbend	Springfield	Oregon
United States	Stamford Hospital	Stamford	Connecticut
United States	Beaumont Hospital, Troy	Troy	Michigan
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	George Washington University Hospital	Washington	District of Columbia
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Henry Ford Health System	Abiomed Inc., Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United States, 

References & Publications (11)

Bainey KR, Armstrong PW. Transatlantic Comparison of ST-Segment Elevation Myocardial Infarction Guidelines: Insights From the United States and Europe. J Am Coll Cardiol. 2016 Jan 19;67(2):216-229. doi: 10.1016/j.jacc.2015.11.010. Epub 2015 Dec 23. Review. — View Citation

Basir MB, Kapur NK, Patel K, Salam MA, Schreiber T, Kaki A, Hanson I, Almany S, Timmis S, Dixon S, Kolski B, Todd J, Senter S, Marso S, Lasorda D, Wilkins C, Lalonde T, Attallah A, Larkin T, Dupont A, Marshall J, Patel N, Overly T, Green M, Tehrani B, Tru — View Citation

Basir MB, Schreiber T, Dixon S, Alaswad K, Patel K, Almany S, Khandelwal A, Hanson I, George A, Ashbrook M, Blank N, Abdelsalam M, Sareen N, Timmis SBH, O'Neill Md WW. Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: The Detroit cardiogenic shock initiative. Catheter Cardiovasc Interv. 2018 Feb 15;91(3):454-461. doi: 10.1002/ccd.27427. Epub 2017 Dec 20. — View Citation

Basir MB, Schreiber TL, Grines CL, Dixon SR, Moses JW, Maini BS, Khandelwal AK, Ohman EM, O'Neill WW. Effect of Early Initiation of Mechanical Circulatory Support on Survival in Cardiogenic Shock. Am J Cardiol. 2017 Mar 15;119(6):845-851. doi: 10.1016/j.amjcard.2016.11.037. Epub 2016 Dec 18. — View Citation

Goldberg RJ, Makam RC, Yarzebski J, McManus DD, Lessard D, Gore JM. Decade-Long Trends (2001-2011) in the Incidence and Hospital Death Rates Associated with the In-Hospital Development of Cardiogenic Shock after Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2016 Mar;9(2):117-25. doi: 10.1161/CIRCOUTCOMES.115.002359. Epub 2016 Feb 16. — View Citation

Hochman JS, Sleeper LA, White HD, Dzavik V, Wong SC, Menon V, Webb JG, Steingart R, Picard MH, Menegus MA, Boland J, Sanborn T, Buller CE, Modur S, Forman R, Desvigne-Nickens P, Jacobs AK, Slater JN, LeJemtel TH; SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. One-year survival following early revascularization for cardiogenic shock. JAMA. 2001 Jan 10;285(2):190-2. — View Citation

Killip T 3rd, Kimball JT. Treatment of myocardial infarction in a coronary care unit. A two year experience with 250 patients. Am J Cardiol. 1967 Oct;20(4):457-64. — View Citation

Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, Fonarow GC. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States. J Am Heart Assoc. 2014 Jan 13;3(1):e000590. doi: 10.1161/JAHA.113.000590. — View Citation

O'Neill W, Basir M, Dixon S, Patel K, Schreiber T, Almany S. Feasibility of Early Mechanical Support During Mechanical Reperfusion of Acute Myocardial Infarct Cardiogenic Shock. JACC Cardiovasc Interv. 2017 Mar 27;10(6):624-625. doi: 10.1016/j.jcin.2017.01.014. — View Citation

Stretch R, Sauer CM, Yuh DD, Bonde P. National trends in the utilization of short-term mechanical circulatory support: incidence, outcomes, and cost analysis. J Am Coll Cardiol. 2014 Oct 7;64(14):1407-15. doi: 10.1016/j.jacc.2014.07.958. — View Citation

Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Böhm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of MCS Pre-PCI	Number of patients who receive mechanical circulatory support (MCS) pre-PCI (percutaneous coronary intervention).	At index Cath Lab procedure/PCI (percutaneous coronary intervention)
Other	Door to Support Time < 90 Minutes	Time from patient presentation at hospital to time that MCS (mechanical circulatory support) was started.	At index Cath Lab procedure/PCI (percutaneous coronary intervention)
Other	Establish TIMI III Flow	Establishment of TIMI III (thrombolysis in myocardial infarction) coronary blood flow during index PCI (percutaneous coronary intervention) in culprit lesions.	At index Cath Lab procedure/PCI (percutaneous coronary intervention)
Other	Wean off Vasopressors & Inotropes	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).	At index PCI (percutaneous coronary intervention), 12-hours post-PCI, 24-hours post-PCI
Other	Maintain CPO >0.6 Watts	Ability to maintain a cardiac power output (CPO) measurement of > 0.6 watts.	At index PCI (percutaneous coronary intervention), 12-hours post-PCI, 24-hours post-PCI
Primary	Survival to discharge from hospital	All cause mortality at hospital discharge.	Hospital discharge (average= 11 days)
Secondary	30 Day Mortality	All cause mortality at 30 days post-discharge.	30 days
Secondary	1 Year Mortality	All cause mortality at 1 year post-discharge	1 year

External Links

•   National Cardiogenic Shock Initiative Website - Henry Ford Hospital