Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock

• Conditions: STEMI; Acute Myocardial Infarction of Right Ventricle (Disorder); STEMI - ST Elevation Myocardial Infarction; NSTEMI; Cardiogenic Shock; NSTEMI - Non-ST Segment Elevation MI; Acute Myocardial Infarction of Left Ventricle; Acute Myocardial Infarction With ST Elevation; Acute Myocardial Infarction

• Registration Number: NCT05800951
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study Start: 2022-07-22
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital discharge survival/survival at 30 days	Hospital discharge survival/survival at 30 days	Hospital discharge survival/survival at 30 days

Secondary Outcome Measures

Name	Time	Method
All-cause mortality at 1 year	All-cause mortality at 1 year	All-cause mortality at 1 year

Trial Locations

Locations (17)

Spectrum Health Hospitals Fred and Lena Meijer Heart Center; 🇺🇸 Grand Rapids, Michigan, United States

Hackensack Meridian Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

Fort Sanders Regional Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Parkwest Medical Center; 🇺🇸 Nashville, Tennessee, United States

UVA University Hospital; 🇺🇸 Charlottesville, Virginia, United States

Providence St. Joseph Hospital Orange; 🇺🇸 Orange, California, United States

Methodist Hospital; 🇺🇸 San Antonio, Texas, United States

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

St. Anthony Hospital; 🇺🇸 Lakewood, Colorado, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

George Washington University Hospital; 🇺🇸 Washington, 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

Lehigh Valley Hospital-Cedar Crest; 🇺🇸 Allentown, Pennsylvania, United States

Ascenion St. John Hospital; 🇺🇸 Detroit, Michigan, United States

TriStar Centennial Medical Center; 🇺🇸 Nashville, Tennessee, United States