Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock (CERAMICS)

April 14, 2026 updated by: Mir Babar Basir, Henry Ford Health System

Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock (CERAMICS Study)

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Orange, California, United States, 92868
        • Providence St. Joseph Hospital Orange
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • St. Anthony Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • George Washington University Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital Atlanta
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Edgewood Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48236
        • Ascenion St. John Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospitals Fred and Lena Meijer Heart Center
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Hackensack Meridian Jersey Shore University Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Fort Sanders Regional Medical Center
      • Nashville, Tennessee, United States, 37203
        • TriStar Centennial Medical Center
      • Nashville, Tennessee, United States, 37923
        • Parkwest Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Methodist Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who present with an acute myocardial infarction (AMI) with cardiogenic shock (AMICS) prior to PCI.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital discharge survival/survival at 30 days
Time Frame: Hospital discharge survival/survival at 30 days
Hospital discharge survival/survival at 30 days
Hospital discharge survival/survival at 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality at 1 year
Time Frame: All-cause mortality at 1 year
All-cause mortality at 1 year
All-cause mortality at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

Abiomed Inc.

Investigators

  • Principal Investigator: Mir B Basir, DO, Henry Ford Health
  • Principal Investigator: William W O'Neill, MD, Henry Ford Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERAMICS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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