Clinical trial NCT05800951: Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock
Official title: Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock (CERAMICS Study)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cardiogenic Shock
Acute Myocardial Infarction
STEMI - ST Elevation Myocardial Infarction
NSTEMI - Non-ST Segment Elevation MI
STEMI
NSTEMI
Acute Myocardial Infarction of Right Ventricle (Disorder)
Acute Myocardial Infarction of Left Ventricle
Acute Myocardial Infarction With ST Elevation
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Abiomed Inc.
First posted: 2023-04-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who present with an acute myocardial infarction (AMI) with cardiogenic shock (AMICS) prior to PCI.

Brief summary: The CERAMICS study is designed to more clearly delineate the current care of acute myocardial infarction with cardiogenic shock (AMICS) patients who are treated with mechanical circulatory support (MCS) devices in the United States with significant experience in MCS, all of whom have the capability of MCS escalation on-site. Study enrollment is targeted at 120 patients at 20 hospital sites, evaluating clinical outcomes, and focusing on outcomes MCS escalation decision making and ICU level management.

Detailed description: The National Cardiogenic Shock Initiative (NCSI) was an initial step in helping to provide team based protocolized care in AMICS. Over the past 5 years, further evaluation and research has helped identify additional best practices that may contribute to further improving outcomes.

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of acute AMI confirmed by a medical professional, with changes in serum biomarkers or evidence of ischemic EKG changes (STEMI or NSTEMI).
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 Registry Exclusion Criteria:

AMICS patients who meet any of the following study exclusion criteria will have a limited set of data collected via a single-page Patient Exclusion Form completed and submitted within 45 days of hospital discharge, which includes the reason for exclusion, date of index PCI, and assessment of patient survival to hospital discharge:

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 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.

Primary outcomes:
measure: Hospital discharge survival/survival at 30 days
timeFrame: Hospital discharge survival/survival at 30 days
Secondary outcomes:
measure: All-cause mortality at 1 year
timeFrame: All-cause mortality at 1 year
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Orange
country: United States
facility: Providence St. Joseph Hospital Orange
state: California
city: Lakewood
country: United States
facility: St. Anthony Hospital
state: Colorado
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Northside Hospital Atlanta
state: Georgia
city: Edgewood
country: United States
facility: St. Elizabeth Edgewood Hospital
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Ascenion St. John Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals Fred and Lena Meijer Heart Center
state: Michigan
city: Neptune
country: United States
facility: Hackensack Meridian Jersey Shore University Medical Center
state: New Jersey
city: Allentown
country: United States
facility: Lehigh Valley Hospital-Cedar Crest
state: Pennsylvania
city: Knoxville
country: United States
facility: Fort Sanders Regional Medical Center
state: Tennessee
city: Nashville
country: United States
facility: TriStar Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Parkwest Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Charlottesville
country: United States
facility: UVA University Hospital
state: Virginia
Study officials:
affiliation: Henry Ford Health
name: Mir B Basir, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health
name: William W O'Neill, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
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, 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.
citation: 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.