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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03677180
Other study ID # NCSI
Secondary ID National CSI
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 allClick 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
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