Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock
NCT ID: NCT05800951
Last Updated: 2025-04-27
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
120 participants
OBSERVATIONAL
2022-07-22
2025-12-31
Brief Summary
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Detailed Description
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Vasopressors have been identified as being independently associated with worse outcomes and MCS escalation may lead to improvement. While sites participating in the NCSI were early adopters of MCS in AMICS, MCS escalation was open ended and dictated by variable local practice patterns. This contributed to the overall low rate of MCS escalation which occurred in NCSI.
Approximately 30-40% of patients with AMICS have concomitant right ventricular failure (RVF), which is associated with worse morality and may therefore benefit from consideration of early right ventricular mechanical circulatory support (RV-MCS) devices.
A total of 20 total sites will be accepted into the CERAMICS study with the goal of gathering data and outcomes of 120 patients treated at participating centers. The study is expected to collect data for approximately 2 years. Prior to joining the study, each site must have broad adoption of the NCSI treatment algorithm as the standard of care for AMICS among at least 80% of the interventional cardiologists who take STEMI call, as confirmed by the site principal investigator (PI).
It is critically important to track consecutive AMICS patients at each site to assess outcomes by identifying the total sample size treated and to help identify if there were particular biases regarding the use of MCS or escalation of MCS. We will also track survival to hospital discharge of those AMICS patients not treated with MCS via an exclusion form, as well as with patients treated with MCS including when care deviates from the study protocol.
All study data collection is occurring retrospectively at each time-point only using EMR, and there will be no contact between study personnel and patients. Patients will be discharged or deceased at the time of study entry. During participation in the study, study sites will regularly screen all acute MI patient records (STEMI and NSTEMI) for patients who presented with cardiogenic shock (AMICS) via a screening form.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Cardiogenic Shock present as defined by the presence of 2 OR MORE of the following criteria prior to PCI:
* Hypotension: systolic blood pressure ≤ 90mmHg at baseline (prior to PCI) or the use of inotropes or vasopressors to maintain SBP ≥ 90mmHg
* Evidence of end organ hypoperfusion: elevated serum lactate levels (venous or arterial), cool extremities, oliguria/anuria
* Hemodynamic criteria: Cardiac Index of \< 2.2 L/min/m2 or a cardiac power output (CPO) of ≤ 0.6 watts
3. Patient underwent PCI within 12 hours of hospital presentation.
Exclusion Criteria
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 MCS
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 MCS is contraindicated
7. Recent major surgery for which MCS is contraindicated
8. Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
9. Known left ventricular thrombus for which MCS is contraindicated
10. Mechanical aortic prosthetic valve
11. Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.
18 Years
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Henry Ford Health System
OTHER
Responsible Party
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Mir Babar Basir
Director of the Acute Mechanical Circulatory Support Program and STEMI Programs
Principal Investigators
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Mir B Basir, DO
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health
William W O'Neill, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health
Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Providence St. Joseph Hospital Orange
Orange, California, United States
St. Anthony Hospital
Lakewood, Colorado, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Northside Hospital Atlanta
Atlanta, Georgia, United States
St. Elizabeth Edgewood Hospital
Edgewood, Kentucky, United States
Henry Ford Hospital
Detroit, Michigan, United States
Ascenion St. John Hospital
Detroit, Michigan, United States
Spectrum Health Hospitals Fred and Lena Meijer Heart Center
Grand Rapids, Michigan, United States
Hackensack Meridian Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Parkwest Medical Center
Nashville, Tennessee, United States
Methodist Hospital
San Antonio, Texas, United States
UVA University Hospital
Charlottesville, Virginia, United States
Countries
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References
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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.
Hanson ID, Tagami T, Mando R, Kara Balla A, Dixon SR, Timmis S, Almany S, Naidu SS, Baran D, Lemor A, Gorgis S, O'Neill W, Basir MB; National Cardiogenic Shock Investigators. SCAI shock classification in acute myocardial infarction: Insights from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv. 2020 Nov;96(6):1137-1142. doi: 10.1002/ccd.29139. Epub 2020 Jul 16.
Goldsweig AM, Tak HJ, Alraies MC, Park J, Smith C, Baker J, Lin L, Patel N, O'Neill WW, Basir MB; National Cardiogenic Shock Initiative Investigators. Mechanical Circulatory Support Following Out-of-Hospital Cardiac Arrest: Insights From the National Cardiogenic Shock Initiative. Cardiovasc Revasc Med. 2021 Nov;32:58-62. doi: 10.1016/j.carrev.2020.12.021. Epub 2020 Dec 23.
Lemor A, Basir MB, Gorgis S, Todd J, Marso S, Gelormini J, Akhtar Y, Baker J, Chahin J, Abdul-Waheed M, Thukral N, O'Neill W. Impact of Age in Acute Myocardial Infarction Cardiogenic Shock: Insights From the National Cardiogenic Shock Initiative. Crit Pathw Cardiol. 2021 Sep 1;20(3):163-167. doi: 10.1097/HPC.0000000000000255.
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, Truesdell AG, Sharma R, Akhtar Y, McRae T 3rd, O'Neill B, Finley J, Rahman A, Foster M, Askari R, Goldsweig A, Martin S, Bharadwaj A, Khuddus M, Caputo C, Korpas D, Cawich I, McAllister D, Blank N, Alraies MC, Fisher R, Khandelwal A, Alaswad K, Lemor A, Johnson T, Hacala M, O'Neill WW; National Cardiogenic Shock Initiative Investigators. Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1173-1183. doi: 10.1002/ccd.28307. Epub 2019 Apr 25.
Ahlers MJ, Srivastava PK, Basir MB, O'Neill WW, Hacala M, Ammar K, Khalil S, Hollowed J, Nsair A. Characteristics and outcomes of patients presenting with acute myocardial infarction and cardiogenic shock during COVID-19. Catheter Cardiovasc Interv. 2022 Oct;100(4):568-574. doi: 10.1002/ccd.30390. Epub 2022 Sep 7.
Provided Documents
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Document Type: Study Protocol
Related Links
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Henry Ford Hospital web page for NCSI/CERAMICS
Other Identifiers
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CERAMICS
Identifier Type: -
Identifier Source: org_study_id
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